2,379 Director Of Safety jobs in the United States

Cedar Hill Regional Medical Center GW Health will be the first new full-service hospital in Washington, DC in more than 20 years, integrating clinical care with existing community providers, Federally Qualified Health Centers (FQHC's), The George Washington University Hospital, and our Urgent Care Center in Ward 8. This integrated delivery system will establish a robust network of care for all District residents, but more importantly, it will ensure residents of Wards 7 and 8 have access to high quality care in their community. This full-service hospital will include 136 beds (with the ability to expand to 184 beds), a verified trauma center, adult and pediatric emergency departments, maternal health and newborn delivery, an ambulatory pavilion for clinic visits and other outpatient services, a 500-car garage and a helipad for emergency transport. We are seeking an experienced Director of Safety and Security Our ideal candidate will be responsible for the overall delivery and quality of patient care provided in the designated area (s) of responsibility. The manager assists with developing and implementing performance initiatives, ensuring optimal patient safety outcomes, and customer satisfaction. This position responsibilities include managing daily work activities, ensuring quality, productivity and efficiency while assisting in accomplishing strategic and operational objectives. To learn more visit or As a Cedar Hill Regional Medical Center employee, you will be part of an exceptional team with the following benefit offerings: Challenging and rewarding work environment Competitive Compensation & Generous Paid Time Off Excellent Medical, Dental, Vision and Prescription Drug Plans 401(K) with company match and discounted stock plan SoFi Student Loan Refinancing Program Career development opportunities within UHS and its 300+ Subsidiaries! More information is available on our Benefits Guest Website: benefits.uhsguest.com. About Universal Health Services One of the nation's largest and most respected providers of hospital and healthcare services, Universal Health Services, Inc. (UHS) has built an impressive record of achievement and performance. Growing steadily since its inception into an esteemed Fortune 500 corporation, annual revenues were $14.3 billion in 2023. During the year, UHS was again recognized as one of the World's Most Admired Companies by Fortune; and listed in Forbes ranking of America's Largest Public Companies. Headquartered in King of Prussia, PA, UHS has approximately 96,700 employees and continues to grow through its subsidiaries. Operating acute care hospitals, behavioral health facilities, outpatient facilities and ambulatory care access points, an insurance offering, a physician network and various related services located all over the U.S. States, Washington, D.C., Puerto Rico and the United Kingdom. Responsibilities Cedar Hill Regional Medical Center Cedar Hill Regional Medical Center GW Health will be the first new full-service hospital in Washington, DC in more than 20 years, integrating clinical care with existing community providers, Federally Qualified Health Centers (FQHC's), The George Washington University Hospital, and our Urgent Care Center in Ward 8. This integrated delivery system will establish a robust network of care for all District residents, but more importantly, it will ensure residents of Wards 7 and 8 have access to high quality care in their community. This full-service hospital will include 136 beds (with the ability to expand to 184 beds), a verified trauma center, adult and pediatric emergency departments, maternal health and newborn delivery, an ambulatory pavilion for clinic visits and other outpatient services, a 500-car garage and a helipad for emergency transport. We are seeking an experienced Director of Safety and Security Our ideal candidate will be responsible for the overall delivery and quality of patient care provided in the designated area (s) of responsibility. The manager assists with developing and implementing performance initiatives, ensuring optimal patient safety outcomes, and customer satisfaction. This position responsibilities include managing daily work activities, ensuring quality, productivity and efficiency while assisting in accomplishing strategic and operational objectives. To learn more visit or As a Cedar Hill Regional Medical Center employee, you will be part of an exceptional team with the following benefit offerings: Challenging and rewarding work environment Competitive Compensation & Generous Paid Time Off Excellent Medical, Dental, Vision and Prescription Drug Plans 401(K) with company match and discounted stock plan SoFi Student Loan Refinancing Program Career development opportunities within UHS and its 300+ Subsidiaries! More information is available on our Benefits Guest Website: benefits.uhsguest.com. About Universal Health Services One of the nation's largest and most respected providers of hospital and healthcare services, Universal Health Services, Inc. (UHS) has built an impressive record of achievement and performance. Growing steadily since its inception into an esteemed Fortune 500 corporation, annual revenues were $14.3 billion in 2023. During the year, UHS was again recognized as one of the World's Most Admired Companies by Fortune; and listed in Forbes ranking of America's Largest Public Companies. Headquartered in King of Prussia, PA, UHS has approximately 96,700 employees and continues to grow through its subsidiaries. Operating acute care hospitals, behavioral health facilities, outpatient facilities and ambulatory care access points, an insurance offering, a physician network and various related services located all over the U.S. States, Washington, D.C., Puerto Rico and the United Kingdom. Qualifications Qualifications: CHPA required within 1 year of employment, CPP credential preferred 7 years security experience; 3-5 years of experience in a hospital setting 5 years' experience at the department management level Security contracting experience preferred Proven ability to develop and implement comprehensive safety and security policies and procedures to protect patients, staff, visitors, and property Ability to manage security technology systems, including surveillance cameras, access control systems, and alarm systems Proven experience leading and managing diverse workforce Education: AA or Bachelor's degree preferred Skills: Effective communication skills, both verbal and written Effective interpersonal skills Ability to maintain confidentiality Ability to adapt to multiple changing priorities Ability to provide care that is respectful of and responsive to the patient values in clinical decision making EEO Statement All UHS subsidiaries are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates. UHS subsidiaries are equal opportunity employers and as such, openly support and fully commit to recruitment, selection, placement, promotion and compensation of individuals without regard to race, color, religion, age, sex (including pregnancy, gender identity, and sexual orientation), genetic information, national origin, disability status, protected veteran status or any other characteristic protected by federal, state or local laws. We believe that diversity and inclusion among our teammates is critical to our success. Avoid and Report Recruitment Scams At UHS and all our subsidiaries, our Human Resources departments and recruiters are here to help prospective candidates by matching skill set and experience with the best possible career path at UHS and our subsidiaries. During the recruitment process, no recruiter or employee will request financial or personal information (e.g., Social Security Number, credit card or bank information, etc.) from you via email. Our recruiters will not email you from a public webmail client like Hotmail, Gmail, Yahoo Mail, etc. If you suspect a fraudulent job posting or job-related email mentioning UHS or its subsidiaries, we encourage you to report such concerns to appropriate law enforcement. We encourage you to refer to legitimate UHS and UHS subsidiary career websites to verify job opportunities and not rely on unsolicited calls from recruiters. Helping all candidates find great careers is our goal. The information you provide here is secure and confidential. We are now directing you to the original job posting. Please apply directly for this job at the employer’s website. #J-18808-Ljbffr

Associate Director, Safety Science

Location: South San Francisco, CA

As Associate Director, Safety Science, you will lead signal detection efforts, conduct medical reviews of ICSRs, and contribute to the development of aggregate safety reports and risk management plans.

Key Responsibilities:

-Medical review of pre- and post-marketing ICSRs (seriousness, causality, expectedness, MedDRA coding)

-Signal detection and evaluation in collaboration with cross-functional teams

-Preparation of aggregate reports (PSUR, DSUR, PADER, etc.)

-Participation in Safety Management Teams and contribution to RMPs, protocols, IBs, and clinical study reports

Qualifications:

-Clinical or scientific degree (BSN, RN, PharmD, MD, DO, or equivalent)

-Experience in pharmacovigilance or drug safety

-Proficiency with safety databases (e.g., Argus)

-Strong understanding of global safety regulations and ICSR handling

If you’re passionate about drug safety and ready to make an impact, let's connect!

Mama’s Creations, Inc. (NASDAQ: MAMA) is a leading marketer and manufacturer of fresh deli prepared foods, found in over 8,500 grocery, mass, club and convenience stores nationally. The Company’s broad product portfolio, born as MamaMancini’s, from a rich history in Italian foods, now consists of a variety of high quality, fresh, clean and easy to prepare foods to address the needs of both our consumers and retailers. Our vision is to become a one-stop-shop deli solutions platform, leveraging vertical integration and a diverse family of brands to offer a wide array of prepared foods to meet the changing demands of the modern consumer. For more information, please visit

The Director, Safety & Security is responsible for cultivating a culture of safety, security, and operational resilience across all enterprise locations. This role ensures compliance, risk mitigation, and business continuity while aligning with the organization’s core values: Commit to Craftsmanship, Nurture Relationships, Honor Heritage, and deliver on our promise of Grandma Quality. The Director provides executive oversight of all safety and security operations, leads a network of site safety managers and functional leaders, and is accountable for ensuring every employee embraces a Safety-First mindset.

This role may be based in our East Rutherford, NJ, or Farmingdale, NY location.

Key Responsibilities

• Develop, implement, enforce, and continuously improve a company-wide safety strategy rooted in craftsmanship, with rigorous standards that reflect our uncompromising commitment to Grandma Quality.
• Champion a proactive safety culture that values learning, accountability, and operational excellence, consistent with our commitment to Honor Heritage by protecting the legacy of safe work practices.
• Oversee and standardize incident reporting and Root Cause Analysis (RCA) protocols across all sites; ensure investigations lead to prevention-focused outcomes.
• Lead the creation and implementation of a comprehensive new hire, and continuing education safety training program to ensure preparedness before independent work, departmental transfer, and new process readiness.
• Build a behavior-based safety training program that nurtures responsibility at every level and reflects our belief in Nurturing Relationships through honest feedback and peer accountability.
• Ensure full compliance with OSHA-mandated training while embedding continuous learning into day-to-day culture through meaningful, hands-on education.
• Establish and manage a standardized condition audit program using lean and 5S principles to define “what good looks like” and uphold environments consistent with our Grandma Quality expectations.
• Promote Total Employee Involvement (TEI) by empowering all employees to take ownership of safety, reinforcing our belief in Nurturing Relationships and shared responsibility.
• Lead the development of digital hazard maps and structured risk prediction practices that reinforce forward-thinking hazard control—consistent with our commitment to craftsmanship.
• Oversee implementation of physical safeguards, PPE, and process controls that uphold the integrity and safety of our facilities.
• Own the enterprise-wide emergency response and crisis management strategy including evacuation, active threat, and HAZMAT protocols—protecting our people and honoring the responsibility we carry as stewards of our teams and facilities.
• Oversee physical security measures (CCTV, badge access, fencing, restricted areas) that ensure safe, secure, and compliant operations across all sites.
• Partner with IT to develop and implement a company-wide business continuity strategy
• Lead, mentor, and develop a high-performing network of site Safety Managers and Safety Functional Leaders (SFLs) across all shifts and facilities.
• Create recognition and reward systems that celebrate positive safety behaviors—to sustain a culture of excellence.
• Partner closely with People Operations and Plant Operations to ensure aligned, values-driven execution of safety and compliance strategies.

Qualifications

• Bachelor’s degree in Occupational Safety, Environmental Health, Risk Management, or related field
• 10–15 years of progressive safety and security leadership experience, including at least 5 years in a multi-site food or regulated manufacturing environment
• Certified Safety Professional (CSP) or equivalent credential strongly preferred
• Proven leadership in behavior-based safety, emergency planning, and regulatory compliance
• In-depth knowledge of OSHA, EPA, FDA, USDA, and industry standards
• Strong communicator and relationship-builder—able to influence and Nurture Relationships with employees at all levels and instill confidence and trust
• Results-driven with a passion for continuous improvement and a deep sense of ownership—a reflection of our commitment to craftsmanship
• Bilingual (English/Spanish) highly preferred

Essential Physical Requirements

• Ability to travel between all company facilities
• Ability to visually/physically inspect manufacturing environments including production floors, rooftops, and confined spaces
• Must be able to wear all required PPE and operate effectively in varying conditions (cold, heat, humidity, noise)

· Occasional lifting (up to 35 lbs) and prolonged standing or walking required during audits and site assessments

Salary commensurate with experience in the $140k - $160k range plus bonus eligibility. We offer health, dental, vision, and life insurances, FSA, PTO, holidays, and 401(k)

PLEASE APPLY VIA RESUME SUBMISSION VIA EMAIL

Qualified, interested candidates should submit a resume and/or detailed letter of interest to the office of People Operations via email at  

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Join to apply for the Assistant Director, Safety & Security role at BXP, Inc.

Primary Purpose of Position:

The Assistant Director, Safety & Security supports and assists in providing leadership, guidance, and implementation of regional security operations and emergency preparedness and management for the safety and security of all tenants, vendors, visitors and the protection of assets. With direction from the Director, Safety & Security and in partnership with the regional management team, this role manages and administers policies, procedures and technical standards related to security and emergency operations, while ensuring delivery of services, staffing, utilization of technology, and policies and procedures are prudent, cost effective and compliant with federal, state and local laws and regulations.

Job Description

Primary Purpose of Position:

The Assistant Director, Safety & Security supports and assists in providing leadership, guidance, and implementation of regional security operations and emergency preparedness and management for the safety and security of all tenants, vendors, visitors and the protection of assets. With direction from the Director, Safety & Security and in partnership with the regional management team, this role manages and administers policies, procedures and technical standards related to security and emergency operations, while ensuring delivery of services, staffing, utilization of technology, and policies and procedures are prudent, cost effective and compliant with federal, state and local laws and regulations.

Essential Functions:

Operations and Planning:

• Oversee security operations and collaborate with uniformed security service provider leadership to ensure compliance with all administrative and contractual requirements and all applicable policies, procedures, rules, and regulations.
• Review incident and activity reports to identify trends or direct corrective/preventative action.
• Interface extensively with regional management staff to ensure adequate and effective service levels are being provided and that tenant security and safety concerns are addressed. Research and analyze problems and concerns regarding security and safety issues. Respond to inquiries and recommend appropriate action.
• Maintain and update Emergency Preparedness and Management Plans in compliance with applicable laws. Assist in the coordination of developing and executing the regional Business Continuity Plan.
• Assist with managing overall operating and capital budgets regarding security and emergency preparedness and management. Provide support of the annual security operating budget and re-forecasts at the property level.
• Coordinate periodic inspections, incident after action reviews, and assessments of existing security and emergency preparedness programs. Identify and recommend improvement opportunities or enhancements. Perform feasibility and cost benefit analyses.
• Collaborate with regional leadership on projects and events and coordinate security and emergency preparedness support and assistance.
  
  

• Coordinate installation, maintenance and operation of existing security and emergency systems and related software with external service provider vendor teams, Information Systems teams, and on-site security, and property management teams.
• Collaborate with Development, Construction, Information Systems teams, and on-site security and property management teams for the design, specification, and implementation of integrated systems for new development projects, building improvement opportunities, and property re-positioning.
• Assist with researching and conducting cost benefit feasibility studies of new and innovative technology, products, and procedures for potential future implementation. Identify existing systems integrations for potential upgrade, replacement, or efficiency improvement opportunities.
  
  

• Interface extensively with tenant management on all matters relating to security and emergency preparedness and management, focusing on quality service delivery and client satisfaction.
• Coordinate and facilitate security and emergency operations seminars and awareness programs, and tabletop and readiness exercises for regional management staff, on-site service providers, and tenants. Coordinate mutual integration of building emergency plans with tenant business continuity plans.
• Maintain ongoing relationships and collaborate regularly with local business community security/emergency management leadership and local, state, and federal law enforcement, public safety and emergency response officials for mutual information sharing.
• Maintain up-to-date knowledge of security and emergency preparedness and management principles, practices, technology, and design, as well as applicable laws and regulations. Consult with security and emergency management colleagues, law enforcement and fire safety agencies, and industry vendors to discuss industry-wide approaches to common issues.
• Participate in security, emergency management, and commercial real estate local associations related meetings and events.
  
  

• BA/BS in business administration, criminal justice or related field and/or comparable experience in security/safety management positions, preferred.
• A minimum of 5 -10 years experience in asset protection and loss prevention.
• Physical Security Professional (PSP) or Certified Emergency Manager (CEM) desirable.
• Commercial Real Estate (CRE) experience preferred.
• In-depth knowledge of security/safety principles, standards, operations, and technology.
• Excellent written and oral communication skills.
• Proven initiative and the ability to create program timetables and execute them.
• Ability to work independently, as well as part of a team.
• Excellent analytical and project management skills.
• Demonstrated skills for organization and multi-task prioritization.
• Ability to coordinate work efficiently, set priorities and motivate others.
• Effective problem solving skills.
• Ability to work in a fast paced environment and adaptability to changing demands.
• Ability to provide quality customer service and excellent client/tenant relations.
• Proficiency with Microsoft Office Applications.
• Flexibility with being on-call around-the-clock (24x7) and working nights and weekends as needed for special events or responding to emergencies.
• Certified Protection Professional (CPP) desirable.
• Solid understanding of the Life Safety Code, OSHA regulations, and other basic security/safety principles, standards, operations and technology.
  
  

• Involves work of a general office nature usually performed sitting such as operation of a computer.
• Involves work of a general office nature usually performed standing such as operation of a fax and printer.
• Involves work such as tours throughout property portfolio usually performed by walking and by climbing stairs.
• Involves movement between departments to facilitate work.
• Involves potentially stressful situations in responding to and mitigating emergency situations, as well as being exposed to adverse environmental conditions, such as severe weather, fumes, smoke, airborne particles, or caustic chemicals.
• This is an on-site position and requires in-person attendance.
  
  

• Regularly interfaces both verbally and in writing with tenant contacts, leasing, construction, development, and financial teams as well as external vendors, construction professionals, consultants, public safety officials, and with the general public.
  
  

• This position reports to the Director, Safety & Security who provides supervision, guidance and evaluates work performance on a periodic basis.
  
  

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Other, Information Technology, and Management

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Job Title: Associate Director, Safety Science

Job Description:

We are seeking an experienced Associate Director, Safety Science to lead safety signal detection, case review, and aggregate reporting for both investigational and marketed products. This role plays a key part in product safety evaluation across the product lifecycle, ensuring regulatory compliance and contributing to risk management strategies.

Key Responsibilities:

• Perform medical review of pre- and post-marketing individual case safety reports (ICSRs), ensuring accurate MedDRA coding, and proper assessment of seriousness, causality, expectedness, and reportability
• Collaborate cross-functionally to detect, evaluate, and manage potential safety signals
• Prepare and contribute to aggregate safety reports (e.g., PBRERs, DSURs, US PADERs, IND Annual Reports)
• Support development and updates of Risk Management Plans (RMPs) and safety surveillance strategies
• Participate in Safety Management Teams and interface with clinical teams, CROs, regulatory, and medical affairs
• Provide medical safety input for key clinical and regulatory documents including protocols, IBs, CSRs, NDAs/BLAs
• Maintain compliance with safety Data Exchange Agreements when interacting with external partners
• Timely, high-quality ICSR reviews in Argus
• Completed signal evaluation forms and safety signal work-ups
• Aggregate safety reports and RMPs
• Presentation materials for internal safety review committees

Qualifications:

• Degree in a health science field (BSN, RN, PharmD, MD, DO, or equivalent)
• Significant experience in pharmacovigilance or drug safety, with strong knowledge of global safety regulations

Apply now to make a direct impact on the safety of therapies that matter.

• Seniority level Director

• Employment type Contract

• Job function Science
• Industries Biotechnology Research and Pharmaceutical Manufacturing

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Medical insurance

Vision insurance

401(k)

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General Description:

The Associate Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to perform signal detection, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting. Physicians in this role are also expected to provide medical safety assessment. In this role, you will apply effective prioritization, critical thinking, and judgment-based decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal and external stakeholders is an important capability for this role. This role represents GPS Safety Science internally and externally at a global level and functions as an authoritative and professional member of relevant teams.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your manager regarding your actual job responsibilities and any related duties that may be required for the position.

Essential Functions of the Job:

Signal and Safety Data Evaluation

• Lead the identification, analysis, and evaluation of safety data for signal detection from all applicable sources

• Perform signal detection and signal assessment along with required documentation following BeiGene process

• Propose and lead data acquisition strategy, methodology, and approach for safety evaluations

• Lead analysis of safety data and author safety assessment

• Collaborate with PSLs, Safety Scientists, Pharmacoepidemiologists, and other cross-functional personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy

• Execute signal assessment analysis per strategy and assist with the preparation of presentations for Safety Management Team and Company Safety Committee

• Prepare and support the presentation of safety data at safety governance meetings (Safety Management Team and Company Safety Committee) and for Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/Data and Safety Monitoring Board (DSMB)

• Apply judgment-based decision-making principles to contribute to key scientific/clinical discussions

• Apply effective communication skills to lead and facilitate safety team meetings

• Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner

• Lead the development, update, and review of safety communication documents (e.g., Dear Investigator Letter, Informed Consent Form, Investigator's Brochure, Healthcare Professional communications (DHCP letter or DHPC), Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science team members and relevant cross-functional team members

Clinical Trial Support

• Lead the review of safety data and monitor the safety of patients on allocated clinical trials

• Lead the writing and review safety sections and provide safety expertise for development of Protocols, IBs, ICFs, Safety Analysis Plans (SAPs), Tables Figures and Listings (TFLs), Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project/study documents and answer ad-hoc safety queries from ethics committees

• Lead the authoring and review of safety sections of regulatory submissions, e.g., IND/CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members

• Support the authoring of Storyboards and Briefing Books for HA interactions

• Support ad-hoc review of the Safety Management Plans

• Lead Safety Science specific investigator training

Risk Assessment, Regulatory Inquiries, and Periodic Reporting

• Lead the analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report (PADER)/Periodic Adverse Experience Report (PAER), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs)

• Provide high quality support and fulfill additional evaluation requests from health authorities (e.g., PRAC PSUSA) for assigned compounds

• Identify safety related questions from the review of inquiries and assess the impact to applicable safety documents or safety section of clinical or regulatory documents.

• Support strategy development, analysis, and response to safety questions from health authorities, IRBs/ECs

• Author Health Hazard Evaluations

• Contribute to integrated Benefit/Risk assessments

Promote and Advance the Field of Pharmacovigilance

• Contribute to effective execution, communication and influence with internal stakeholders (e.g., clinical development, medical, regulatory, labeling) and external stakeholders (e.g. FDA, MHRA, EMA, other regulatory agencies)

• Contribute to continuous employee development programs, such as mentoring, coaching, and peer-to-peer learning

• Contribute to and provide Safety Science training to support team development

• Demonstrate knowledge and application of pharmacovigilance principles to related tasks that are medium in complexity

• Adhere to requirements in quality system document and process improvement initiatives to ensure compliance with internal processes, local laws and regulations

• Execute any other tasks assigned by manager to assist in departmental activities

Supervisory Responsibilities:

This position has no direct reports. The Associate Director, Safety Scientist is part of a team that performs high quality and timely scientific, operational, and applicable medical safety analysis. This position works closely with the Safety Science group as part of a matrix team to conduct safety assessment and safety risk management activities per BeiGene process and applicable regulations.

Computer Skills:

• Advanced knowledge working with a safety database (i.e., Argus) for retrieval of safety information

• Advanced knowledge of MedDRA and signal management system

• Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., Veeva)

• Advanced knowledge of data mining tools and analyses tools such as Spotfire and PowerBI

Other Qualifications:

• PharmD, NP, RN, or PhD in a medical field or biological science and 4+ years of experience as a Safety (Pharmacovigilance) Scientist.ORMD (or internationally recognized equivalent) plus accredited residency or have completed a comparable level of post-medical school clinical training relevant to the country of hiring. 6+ years of clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of general medicine and ideally 2+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred.

• Pharmaceutical product development experience

• Experienced in global regulatory requirements for pharmacovigilance

Travel: Less than 10%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

• Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving company products to ensure accuracy of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting.
• Assist in follow-up of important ICSRs to ensure relevant information is sought.
• Collaborate with Clinical Science, Medical Affairs, PV colleagues and applicable functional specialists to identify, evaluate and manage safety signals.
• Participate in the development development of safety surveillance and risk management plans for drug development programs.
• Contribute to the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR (PBRER format), US PADER, Annual Safety Report, DSUR, IND Annual Report).
• Serve on Safety Management Team and liaise with clinical study/project teams, Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees and other entities as needed.
• Participate in the preparation and revision of company product labeling and RMP as appropriate.
• Assist with preparation and review safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other safety documents.
• Interface with business partners as needed in accordance with applicable safety Data Exchange Agreements.

• ICSR reviews in Argus safety database.
• Completed quarterly signal evaluation forms.
• Completed signal issue work-ups.
• Completed aggregate reports.
• Risk Management Plans.
• Slide decks for Safety Management Team/Product Safety Committee meetings.