997 Drug Safety jobs in the United States

Job Description

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

The Sr. Manager / Associate Director, Drug Safety will interface and collaborate with cross-department members to provide safety operations support during the set-up of new clinical development programs. The Manager will be responsible for oversight of safety operation activities with Arrowhead CRO vendors and partners, implementing Arrowhead safety reporting processes ensuring compliance with global requirements and monitor compliance of internal standard operating procedures related to drug safety & pharmacovigilance.

Responsibilities

• Lead Case Processing and support safety medical review, generate appropriate queries to contact drug safety vendors (CROs) to complete and clarify SAE case information as needed and work with CRO to determine when cases are complete and ready to close.
• Ensure consistency in investigator causality assessment of SAE reports and source documentation for completeness, accuracy and legibility.
• Participate in the standardized set-up of new safety projects, including development of Safety plans and documents, and set-up of safety systems
• Prepare, support and track PVAs/SDEAs with partners.
• Monitor compliance with partner Safety related activities needed as per PVA/SDEA.
• Create and maintain Safety Management Plans and Reporting documents in collaboration with vendors.
• Review vendor scope and assist with study level budgets as needed.
• Provide vendor oversight, including tracking KPI's and collaborate with multiple vendors for process setup & improvements.
• Perform and manage SAE reconciliation between databases.
• Responsible for data clean-up and data migration from vendor Safety database.
• Oversee submission activities for ICSRs and aggregate reports.
• Collaborate with vendors for TMF Safety documents filing and review.
• Manage day to day operation of Safety database.
• Ensure that reported SAE (and events of special interest to include pregnancy and overdose) event reports are received, tracked, evaluated, processed and distributed/submitted in an efficient and timely manner, and in compliance with regulations and Arrowhead Management Plans/SOPs.
• Coordinate with vendors to ensure all internal/external timelines are met per PVA and ensure, potential issues are communicated, and resolution is achieved in a timely manner.
• Support activities related to implementing and maintaining the Safety Database, supporting ARGUS activities, Overseeing the Safety Vendors, and coordinating the Safety Reporting from Clinical Trials and Collaborators.
• Support other members of Safety Operations and Science personnel and ensure flawless execution of Safety and Pharmacovigilance processes
• Vendor management, manage Safety Vendors, CRO and other external parties helping Arrowhead's drug Safety and Pharmacovigilance.
• Facilitate the analysis of similar events for expedited safety reports occurring in pre-marketed clinical studies.
• Participate in tracking/monitoring of cases and other vendor or partner deliverables to ensure quality and timeliness of safety management activities, as well as adherence to regulatory and contractual obligations.
• Provide drug safety case management support to Safety medical monitors; assist in following up on queries for case reports, abnormal laboratory values, or any other relevant safety and medical data.
• Assist with the development and maintenance of departmental SOPs and other procedural documents.
• Support reviewing and monitoring of SAE/SUSAR case processing including, performing the secondary quality review for all case reports in the safety
• Support the development and updating of Clinical Risk Management Plans for all clinical Prepare and update study-specific Safety Monitoring Plans as needed
• Help in compiling safety data required for DSC and DSMB meetings for Arrowhead clinical studies
• Monitor SAE reconciliation with the Arrowhead PV vendor and study CRO to ensure the reconciliation process is occurring for all clinical studies
• Liaise with other company departments including, Clinical Operations, Quality, Regulatory, etc., and provide drug safety
• Participate in inspection-readiness activities to included document and eTMF support.
• Collaborate with Regulatory personal and CROs to communicate upcoming SAEs requiring expedited submissions to Regulatory Authorities, to include ad hoc reporting responsibilities form Arrowhead Safety.
• Support the Manager of Safety Operations and Head of Clinical Safety in the review and development of written materials including clinical trial protocols, Informed Consent Forms, Case Report Forms, adverse event (AE)/ serious adverse event {SAE) reporting forms, Clinical Study Reports, and Investigator's Brochures (including Reference Safety Information determinations)
• Informs Manager of safety related issues and potential trends and or signals arising from review of post-marketed safety data.
• Assist with safety database test configurations.
• Assist with review of cross-functional documents/plans (e.g., protocols, SAE Reconciliation Plans, etc.)
• Participate in tracking/monitoring of cases and other vendor or partner deliverables to ensure quality and timeliness of safety management activities, as well as adherence to regulatory and contractual obligations.
• Help in managing and updating safety surveillance procedures including signal detection review processes and monitoring abnormal trending of adverse events and laboratory results
• Support monitoring safety surveillance for Arrowhead's clinical development products to ensure corporate compliance with national and international adverse event reporting requirements
• Maintenance of Arrowhead safety operations documentation (e.g., safety case files), and management of the Safety Mailboxes.
• Help in quality assurance activities, including deviation reports and generating necessary CAPA to ensure Arrowhead is meeting all safety compliance requirements
• Participate in the production and validation of appropriate safety data output from the external or internal safety database for required safety deliverables (e.g. DSUR, IB, ad hoc analyses etc.).
• Manage Arrowhead's QMS for safety/Pharmacovigilance procedures
• Participate in and Help with preparation for regulatory inspections including a compiling of material relating to safety/pharmacovigilance reports and activities
• Responsible for UAT and Implementation of updates within Safety Database.
• Responsible for Argus console activities like maintaining user sites, groups, accounts, workflow, product, study configurations, and reporting rules.
• Perform periodic MedDRA and WHO Drug upgrades.
• Assist with periodic Disaster recovery and Business continuity tests as needed with Safety Database.
• Support Drug Safety team with listings and data from the Argus database.
• Author and maintain SOPs and WIs for Safety procedures.

Requirements:

• Minimum of BS/BA degree in a health-related area (RN/BSN) and 8 years in the pharmaceutical industry or CRO
• 5-10 years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience
• Prior experience in Safety/Pharmacovigilance Operations is required.
• Strong working knowledge of case management and Experience in using ARGUS or other safety databases. Experience with MedDRA/WHO for coding AEs, medical history, and concomitant medications
• Experience with preparation with aggregate reports, preferably for investigational drugs (i.e., DSURs, IND Annual reports) or post-marketing products (i.e., PSUR/PBRER, PADERs)
• Working experience with Safety Databases (Argus, ArisG or other) is required.
• Knowledge of ICH E2B guidelines in clinical and post-marketing studies.
• Good organizational skills with the ability to perform multiple tasks efficiently and effectively.

California pay range

$150,000—$185,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.

California Applicant Privacy Policy

Job Description

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

The Manager of Safety Operations will be responsible for the flawless execution of Safety and Pharmacovigilance operations, reporting to and assisting the VP/Head of Drug Safety and Pharmacovigilance in implementing Arrowhead's safety reporting processes and ensuring compliance with FDA, international and global safety reporting requirements for all investigational clinical products, including monitoring and compliance of internal standard operating procedures related to drug safety. He/she will be responsible for maintaining Arrowhead's safety database, preparation and review of regulatory reports such as serious unexpected serious adverse reactions (SUSARs) and periodic aggregate reports in compliance with FDA, EMA and other international guidelines and regulations for the clinical programs. The manager will interface and collaborate with Clinical Operations, Quality Assurance, and Regulatory team members and provide safety support during the set-up of new clinical development programs as well as assist in the oversight of local CRO vendors who perform local safety reporting for Arrowhead.

Responsibilities

• Lead activities related to implementing and maintaining the Safety Database, supporting ARGUS activities, Overseeing the Safety Vendors, and coordinating the Safety Reporting from Clinical Trials and Collaborators.
• Support and/or Lead Safety Operations and ensure flawless execution of Safety and Pharmacovigilance processes
• Vendor management, manage Safety Vendors, CRO and other external parties helping Arrowhead's drug Safety and Pharmacovigilance.
• Provide drug safety case management support to medical monitors; assist in following up on queries for case reports, abnormal laboratory values, or any other relevant safety and medical data
• Lead reviewing and monitoring of SAE/SUSAR case processing including, performing the secondary quality review for all case reports in the safety
• Supervise the development and updating of Clinical Risk Management Plans for all clinical Prepare and update study-specific Safety Monitoring Plans as needed
• Oversee compiling safety data required for DSC and DSMB meetings for Arrowhead clinical studies
• Monitor SAE reconciliation with the Arrowhead PV vendor and study CRO to ensure the reconciliation process is occurring for all clinical studies
• Liaise with other company departments including, Clinical Operations, Quality, Regulatory, etc., and provide drug safety support
• Support the Head of Safety in the review and development of written materials including clinical trial protocols, Informed Consent Forms, Case Report Forms, adverse event (AE)/ serious adverse event {SAE) reporting forms, Clinical Study Reports, and Investigator's Brochures (including Reference Safety Information determinations)
• Supervise managing and updating safety surveillance procedures including signal detection review processes and monitoring abnormal trending of adverse events and laboratory results
• Oversee monitoring safety surveillance for Arrowhead's clinical development products to ensure corporate compliance with national and international adverse event reporting requirements
• Support in quality assurance activities, including deviation reports and generating necessary CAPA to ensure Arrowhead is meeting all safety compliance requirements
• Manage Arrowhead's QMS for safety/Pharmacovigilance procedures
• Oversee with preparation for regulatory inspections including a compiling of material relating to safety/pharmacovigilance reports and activities

Requirements:

• Minimum of BS/BA degree in a health-related area
• 10 years in the pharmaceutical industry or CRO with at least 6 years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience
• Strong working knowledge of FDA and international adverse event reporting regulations (ICH, EMA GPV, GCP etc.) and the ability to interpret and apply applicable regulations
• Strong working knowledge of case management and Experience in using ARGUS or other safety databases. Experience with MedDRA/WHO for coding AEs, medical history, and concomitant medications
• Experience with preparation with aggregate reports, preferably for investigational drugs (i.e., DSURs, IND Annual reports) or post-marketing products (i.e., PSUR/PBRER, PADERs)
• Experience with quality assurance and compliance for drug safety
• Experience with regulatory inspections, as well as audits of service vendors/business partners would be helpful
• Good organizational skills with the ability to perform multiple tasks efficiently and effectively while mentoring and leading team members
• Proficiency in standard desktop software programs (Word, Excel, Outlook)
• Competency in obtaining, analyzing, and reporting safety data
• Strong oral and written communication skills
• Motivated self-starter who can lead teams and work independently
• Strong interpersonal skills with the ability to professionally interact with all levels of personnel

California pay range

$115,000—$135,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.

California Applicant Privacy Policy

The Associate Medical Director, Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials, identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products. The Global Safety Physician will represent Biogen Safety in internal and external meetings. The Global Safety Physician can be appointed as the Global Safety Officer for a specific product.

The Global Safety Physician will demonstrate the flexibility and capability to function at a high level across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through their life cycle.

1. Manage safety surveillance for assigned products

2. Provide safety strategic leadership for clinical development programs

a. Integrate the safety scientific component to build a strategic framework for clinical development plans.

3. Develop and maintain relationships with counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, Worldwide Medical.

4. Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timelines and timelines set by regulatory authorities.

This position is hybrid based in Cambridge, MA (USA).

You are a proven leader in safety & pharmacovigilance. You strive on developing, executing and advancing successful programs in development. You have experience working / leading high performing teams; providing the necessary guidance and mentoring for all to reach their goals.

Qualifications:

• MD or MD/PhD required; subspecialty focus in neuroscience, psychiatry, immunology, rare diseases preferred.
• Minimum 3+ years experience in the pharmaceutical industry or clinical care setting; ideally specific to pharmacovigilance.
• Prior experience in clinical trials preferred; academic and/or industry.
• Knowledge of pre- and post- marketing US and EU regulations.

Additional Information:

The base compensation range for this role is: $182,000.00-$50,000.00. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to 10,000 per calendar year
• Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

• MD or MD/PhD required; subspecialty focus in neuroscience, psychiatry, immunology, rare diseases preferred.
• Minimum 3+ years experience in the pharmaceutical industry or clinical care setting; ideally specific to pharmacovigilance.
• Prior experience in clinical trials preferred; academic and/or industry.
• Knowledge of pre- and post- marketing US and EU regulations.

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to 10,000 per calendar year
• Employee Resource Groups participation

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We're pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

Medical Director - Drug Safety Physician

Summary:

The Medical Director, Drug Safety Physician, collaborates with the Product Lead or Head of Drug Safety and is responsible for the clinical safety strategy for assigned drug projects and products. They provide drug safety expertise and guidance to Clinical Development, the Safety Oversight Committee (SOC), and the Clinical Project Teams, while also leading the proactive implementation of risk management initiatives in accordance with global regulatory requirements.

Responsibilities:

• Performs individual case report assessment and determines regulatory reporting responsibilities as required
• Provides medical review of case narratives for medical content, accuracy, and signal detection
• Interprets aggregate safety data for periodic reports and evaluating for potential new signals
• Provides support and is capable of leading signal detection, signal evaluation, data analysis, and benefit-risk evaluation for assigned compounds, including ability to author signal report in response to Health Authority inquiries
• Provides support and can lead risk management and risk mitigation activities, including medical and safety leadership for RMPs
• Writes individual case assessments and evaluates aggregate safety data for periodic reports as required
• Provides medical input into identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals
• Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources in order to predict/establish the safety profile of compounds in clinical development
• Offers medical judgment on complex safety issues
• Works cross functionally with clinical to determine the most appropriate monitoring and
• stopping rules for clinical trial protocols in partnership with the project's medical monitor
• Supports and can present safety data to DSMBs for assigned products
• Collaborates with partner company's drug safety team and clinicians, and provides regular
• safety summaries
• Contributes to/reviews the Safety Data Exchange Agreements and other documents shared with partners; provides vendor oversight for assigned products
• Participates in cross-functional project teams; communicates across organizational levels and functions
• Participates in SOP updates, audits, and inspection readiness
• Writes/updates core safety information for assigned projects
• Writes/reviews and provides technical input for the safety sections of regulatory documents for assigned projects (i.e., protocols, IBs, ICFs, CSRs, IND/MAA submissions, RMP, annual reports, etc.)
• Prepares and/or reviews safety documents (DSURs, PBRERs, 6MLL, etc) and provides strategic input into responses to regulatory inquiries
• Participates in external regulatory and non-regulatory meetings, including those with consultants and other companies, such as licensing partners
• May assist in due diligence activities
• May provide support to Legal for product liability litigation, as appropriate
• Supports the medical coding group on an ad hoc basis
• Participates in reconciliation procedures
• Guides and/or trains external personnel/parties involved in Ionis' clinical studies
• Collaborates effectively in cross-functional and cross-cultural project teams and environments, and work with external providers
• Maintains clinical and technical expertise in the therapeutic areas in which Ionis operates (i.e., through review of scientific journals, attendance at scientific and key technical meetings, etc.)
• May support and/or contribute to writing of white papers and other internal scientific publications
• Assists in accomplishing department and corporate objectives
• May participate/present safety material to Investigator's meetings and other medical meetings
• Participates in selection and bidding activities for vendors and contractors
• Managerial responsibilities as required
• Other duties and ad hoc activities as assigned

Requirements:

• Medical degree (e.g., MD, MBBS)
• At least 5 years of clinical experience post-registration
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals
• At least 5 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery
• A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities.
• Able to work across therapeutic areas and functions
• Works collaboratively (establishes shared purpose across boundaries)
• Develops people and the organization (invests in long-term development of others)

The pay scale for this position is $235,553 to $314,252.

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company's pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases.

We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation - TRUE Innovation !

Position Summary:

The Medical Director, Pharmacovigilance role is responsible for providing medical oversight of safety data from clinical trials to ensure proactive and timely benefit-risk assessments for all products in the Zenas portfolio. This is an individual contributor role reporting to the Head of Pharmacovigilance.

Key Responsibilities:

• Performs and oversees medical review of safety events to ensure accuracy, integrity and completeness of safety information, and consistency of medical coding of safety data
• Identifies and evaluates safety signals through the assessment of single case safety reports and aggregate trend analyses
• Participates in cross-functional aggregate medical review with the medical monitors.
• Provides CRO feedback regarding quality of narratives and case processing.
• Leads the internal safety committee meetings and all signaling activities.
• Assists in authoring and reviewing aggregate reports such as DSURS.
• Ensures the ongoing evaluation of the overall safety profile for investigational products, serving as the product safety expert to bring potential safety issues to the attention of the clinical team and leadership
• Contributes to safety sections of clinical documents, including preparing, review and approval of the safety portion of protocols, IBs, ICFs, CSRs, integrated summary of safety (ISS), and other documents, as needed; Drives annual DSUR preparation.
• Provides input and review of responses to regulatory agency questions regarding patient safety
• Establishes and maintains policies and procedures for the PV function

• MD with a minimum of 8 years Drug Safety/Pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization
• Working knowledge of relevant FDA, EU, ICH guidelines and regulations
• Experience working with CRO/vendors, and relationship management preferred
• Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
• Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding
• Outstanding communication skills (verbal and written)
• Ability to manage multiple projects in a fast-paced environment
• Ability to effectively collaborate in a dynamic, cross-functional matrix environment
• The ability to establish and maintain excellent relationships when dealing with sensitive and/or complex issues and tight timelines.
• Ability to lead and influence project teams, committees, etc.
• Demonstrate excellent leadership and communication skills.

Job DescriptionJob DescriptionSystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

This individual is to lead medical assessment and interpretation of safety data from multiple sources, including clinical trials, and literature reports.  The individual will be closely collaborating with cross functional teams in supporting all clinical development programs, regulatory filling, and global safety related activities. This individual will also support the clinical R&D team in the oversight of PV service vendors and partners and will need to maintain medical knowledge, as well as current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.

This role requires a full-time onsite presence at our Princeton, NJ location.

Responsibilities

• Provide medical safety input and participate in safety surveillance activities (e.g., identification of safety signals and ensure timely assessment and communication of confirmed safety signals).
• Provide input in the of aggregate safety reports (e.g., DSURs, PADER, PBRER).
• Serve as a leading medical safety resource for the development and review of clinical trial protocols, informed consent forms (ICFs), investigator brochures (IBs) and Reference Safety Information (RSI).
• Collaborate with Medical Monitors and Clinical Research Scientists and vendor clinical staff as needed for ongoing clinical trials.
• Provide medical safety input in the development and/or updates of Risk Management Plans and the maintenance of these documents.
• Provide support and input to the development of Standard Operating Procedures, Working Instructions, and other guidance documents.
• Serve as a subject matter expert for vendors that provide drug safety and pharmacovigilance services.
• Work closely with other Product Safety Leads to respond to and resolve safety questions from health authorities as well as regulatory agency’s audits and inspections.

Qualifications

• 5+ years’ experience in Drug Safety/Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency.
• Medical Degree (MD) from a recognized medical school with medical practice experience. Oncology / Hematology experience strongly .
• Strong working knowledge of US and EU drug safety and pharmacovigilance regulations, CIOMS and ICH guidelines.
• Proven experience in medical safety assessments, safety surveillance and risk management activities.
• Proficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and of Analysis of Similar Event and company comment statements, including benefit-risk assessment.
• Experience with preparation of aggregate reports (e.g., DSUR, PSUR/PBRER, PADER)
• Experience in preparation of responses to regulatory authorities; experience with regulatory filing and related activities .

Compensation and Benefits:
The expected base salary range for this position is $150,000 - $250,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise align strongly with the requirements of the role.
 
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
 
We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.
 
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
 

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Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We're pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

MEDICAL DIRECTOR - DRUG SAFETY PHYSICIAN

SUMMARY:

The Medical Director, Drug Safety Physician, collaborates with the Product Lead or Head of Drug Safety and is responsible for the clinical safety strategy for assigned drug projects and products. They provide drug safety expertise and guidance to Clinical Development, the Safety Oversight Committee (SOC), and the Clinical Project Teams, while also leading the proactive implementation of risk management initiatives in accordance with global regulatory requirements.

Major areas of responsibility include continuous efficient evaluation of safety data to perform signal detection and evaluation and predict and manage the safety profile of compounds in clinical development, consistent communication of safety topics across all regulatory safety documents, and strategic collaboration with cross-functional teams in support of the products and Ionis business partners. This position reports to the Safety Team Lead of assigned products.

RESPONSIBILITIES:

• Performs individual case report assessment and determines regulatory reporting responsibilities as required
• Provides medical review of case narratives for medical content, accuracy, and signal detection
• Interpret aggregate safety data for periodic reports and evaluating for potential new signals
• Provides support and is capable of leading signal detection, signal evaluation, data analysis, and benefit-risk evaluation for assigned compounds, including ability to author signal report in response to Health Authority inquiries
• Provides support and can lead risk management and risk mitigation activities, including medical and safety leadership for RMPs
• Writes individual case assessments and evaluates aggregate safety data for periodic reports as required
• Provides medical input into identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals
• Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources in order to predict/establish the safety profile of compounds in clinical development
• Offers medical judgment on complex safety issues
• Works cross functionally with clinical to determine the most appropriate monitoring and
• stopping rules for clinical trial protocols in partnership with the project's medical monitor
• Supports and can present safety data to DSMBs for assigned products
• Collaborates with partner company's drug safety team and clinicians, and provisions regular
• safety summaries
• Contributes to/reviews the Safety Data Exchange Agreements and other documents shared with partners; provides vendor oversight for assigned products
• Participates in cross-functional project teams; communicates across organizational levels and functions
• Participates in SOP updates, audits, and inspection readiness
• Writes/updates core safety information for assigned projects
• Writes/reviews and provides technical input for the safety sections of regulatory documents for assigned projects (i.e., protocols, IBs, ICFs, CSRs, IND/MAA submissions, RMP, annual reports, etc.)
• Prepares and/or reviews safety documents (DSURs, PBRERs, 6MLL, etc) and provides strategic input into responses to regulatory inquiries
• Participates in external regulatory and non-regulatory meetings, including those with consultants and other companies, such as licensing partners
• May assist in due diligence activities
• May provide support to Legal for product liability litigation, as appropriate
• Supports the medical coding group on an ad hoc basis
• Participates in reconciliation procedures
• Guides and/or trains external personnel/parties involved in Ionis' clinical studies
• Collaborates effectively in cross-functional and cross-cultural project teams and environments, and work with external providers
• Maintain clinical and technical expertise in the therapeutic areas in which Ionis operates (i.e., through review of scientific journals, attendance at scientific and key technical meetings, etc.)
• May support and/or contribute to writing of white papers and other internal scientific publications
• Assist in accomplishing department and corporate objectives
• May participate/present safety material to Investigator's meetings and other medical meetings
• Participates in selection and bidding activities for vendors and contractors
• Managerial responsibilities as required
• Other duties and ad hoc activities as assigned

• Medical degree (e.g., MD, MBBS)
• At least 5 years of clinical experience post-registration
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals
• At least 5 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery
• A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities.
• Able to work across therapeutic areas and functions
• Works collaboratively (establishes shared purpose across boundaries)
• Develops people and the organization (invests in long-term development of others)

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

MEDICAL DIRECTOR - DRUG SAFETY PHYSICIAN

SUMMARY:

The Medical Director, Drug Safety Physician, collaborates with the Product Lead or Head of Drug Safety and is responsible for the clinical safety strategy for assigned drug projects and products. They provide drug safety expertise and guidance to Clinical Development, the Safety Oversight Committee (SOC), and the Clinical Project Teams, while also leading the proactive implementation of risk management initiatives in accordance with global regulatory requirements.

Major areas of responsibility include continuous efficient evaluation of safety data to perform signal detection and evaluation and predict and manage the safety profile of compounds in clinical development, consistent communication of safety topics across all regulatory safety documents, and strategic collaboration with cross-functional teams in support of the products and Ionis business partners. This position reports to the Safety Team Lead of assigned products.

RESPONSIBILITIES:

• Performs individual case report assessment and determines regulatory reporting responsibilities as required
• Provides medical review of case narratives for medical content, accuracy, and signal detection
• Interpret aggregate safety data for periodic reports and evaluating for potential new signals
• Provides support and is capable of leading signal detection, signal evaluation, data analysis, and benefit-risk evaluation for assigned compounds, including ability to author signal report in response to Health Authority inquiries
• Provides support and can lead risk management and risk mitigation activities, including medical and safety leadership for RMPs
• Writes individual case assessments and evaluates aggregate safety data for periodic reports as required
• Provides medical input into identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals
• Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources in order to predict/establish the safety profile of compounds in clinical development
• Offers medical judgment on complex safety issues
• Works cross functionally with clinical to determine the most appropriate monitoring and
• stopping rules for clinical trial protocols in partnership with the project’s medical monitor
• Supports and can present safety data to DSMBs for assigned products
• Collaborates with partner company’s drug safety team and clinicians, and provisions regular
• safety summaries
• Contributes to/reviews the Safety Data Exchange Agreements and other documents shared with partners; provides vendor oversight for assigned products
• Participates in cross-functional project teams; communicates across organizational levels and functions
• Participates in SOP updates, audits, and inspection readiness
• Writes/updates core safety information for assigned projects
• Writes/reviews and provides technical input for the safety sections of regulatory documents for assigned projects (i.e., protocols, IBs, ICFs, CSRs, IND/MAA submissions, RMP, annual reports, etc.)
• Prepares and/or reviews safety documents (DSURs, PBRERs, 6MLL, etc) and provides strategic input into responses to regulatory inquiries
• Participates in external regulatory and non-regulatory meetings, including those with consultants and other companies, such as licensing partners
• May assist in due diligence activities
• May provide support to Legal for product liability litigation, as appropriate
• Supports the medical coding group on an ad hoc basis
• Participates in reconciliation procedures
• Guides and/or trains external personnel/parties involved in Ionis’ clinical studies
• Collaborates effectively in cross-functional and cross-cultural project teams and environments, and work with external providers
• Maintain clinical and technical expertise in the therapeutic areas in which Ionis operates (i.e., through review of scientific journals, attendance at scientific and key technical meetings, etc.)
• May support and/or contribute to writing of white papers and other internal scientific publications
• Assist in accomplishing department and corporate objectives
• May participate/present safety material to Investigator’s meetings and other medical meetings
• Participates in selection and bidding activities for vendors and contractors
• Managerial responsibilities as required
• Other duties and ad hoc activities as assigned

• Medical degree (e.g., MD, MBBS)
• At least 5 years of clinical experience post-registration
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals
• At least 5 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery
• A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities.
• Able to work across therapeutic areas and functions
• Works collaboratively (establishes shared purpose across boundaries)
• Develops people and the organization (invests in long-term development of others)