2,151 Pharmacovigilance jobs in the United States

September 2, 2025

United States

Corporate FTE

Masters Degree

Non- Technical

No

Full Time

Fulltime

Job Title: Head – Pharmacovigilance & Medical Affairs

Company Overview:

Pulivarthi Group is a trusted global provider of staffing and IT technology solutions. With expertise across healthcare, finance, government, and beyond, we deliver tailored workforce solutions to meet diverse client needs. Operating in the United States, Canada, and Mexico, we pride ourselves on aligning with client cultures, deploying top-tier talent, and ensuring compliance with industry standards.

Job Summary:

We are seeking a Head of Pharmacovigilance & Medical Affairs to lead and oversee pharmacovigilance operations, regulatory compliance, and medical affairs strategy for North America. The role involves managing drug safety, ensuring regulatory adherence, supporting audits and inspections, and providing medical oversight while aligning with corporate and commercial strategies.

Key Responsibilities:

• Manage, create, and review ICSR (US/Foreign) and PSR reports, ensuring timely submission to FDA/Health Canada to maintain 100% compliance with pharmacovigilance regulations.
• Lead drug safety regulatory inspections in the US, anchor FDA audits, and provide corrective action plans post-inspection.
• Establish and manage the Pharmacovigilance Quality Management System (QMS) to meet US regulatory requirements.
• Conduct detailed risk evaluations by comparing current reporting periods with historical data; assess product safety risks and manage REMS programs with regulatory agencies.
• Support development and execution of North America Medical Affairs and Dr. Reddy's Canada Medical Affairs plans, aligning with brand and corporate objectives.
• Oversee medical information services for North America and maintain seamless collaboration with pharmacovigilance service providers.
• Partner cross-functionally to support scientific congress participation, pre-meeting planning, and post-meeting competitive intelligence reporting.
• Drive pharmacovigilance digitalization efforts to enhance efficiency, ensure compliance with 21CFR Part 11, GAMP 5, and GxP standards.

Qualifications:

• Advanced degree in Life Sciences, Pharmacy, Medicine, or related field (MD, PharmD, PhD preferred).
• Proven experience in pharmacovigilance, drug safety, and medical affairs leadership roles.
• In-depth knowledge of US and Canadian regulatory requirements (FDA, Health Canada).
• Strong experience managing regulatory inspections, audits, and pharmacovigilance compliance.
• Demonstrated expertise in risk assessment, REMS management, and QMS implementation.
• Excellent cross-functional collaboration, communication, and leadership skills.
• Experience with digital transformation initiatives in PV systems preferred.

Work Environment:

• Corporate office/remote hybrid with periodic travel for audits, inspections, and conferences.
• Fast-paced, compliance-driven environment.

Benefits:

• Competitive compensation and executive benefits package.
• Opportunity to lead pharmacovigilance and medical affairs at a strategic level.
• Career growth in a global healthcare and pharmaceutical environment.

Equal Opportunity Statement:

Pulivarthi Group is an equal opportunity employer committed to creating a diverse and inclusive workplace. We do not discriminate based on race, religion, color, national origin, gender, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected status.

Full-Time, Hybrid

Permanent Contract

United States (Hybrid – Home based)

The Job

Ennov is recruiting for a US-based Veterinary Pharmacovigilance (PV) Client Success Advocate with experience of working in the animal health industry, primarily in pharmacovigilance.

Ennov being a world leading provider of Veterinary Pharmacovigilance solutions, this recruitment has been initiated to further enhance the range and extent of services that can be offered to an existing prestigious customer base.

The Job

Ennov is recruiting for a US-based Veterinary Pharmacovigilance (PV) Client Success Advocate with experience of working in the animal health industry, primarily in pharmacovigilance.

Ennov being a world leading provider of Veterinary Pharmacovigilance solutions, this recruitment has been initiated to further enhance the range and extent of services that can be offered to an existing prestigious customer base.

Additional Information on the Role

• Our US office is based in Raleigh (NC), but the role is expected to be fully remote, working as part of a regularly connected team.
• Some degree of travel can be expected for this role.
• Salary according to skills and experience.

Required Skills & Experience:

• Excellent veterinary PV subject matter knowledge.
• Familiarity with all aspects of a PV suite, from case management to regulatory report requirements and signal detection & management.
• Experience working on system deployment & upgrade projects.
• Understanding of validation requirements for GxP systems.
• Customer success mindset.

The role will involve taking the lead on solution design and delivery, at the forefront of a focused team providing diverse expertise to a wide range of different contacts. The successful candidate will be self-motivated, dynamic and comfortable contributing to a variety of different challenges and interactions.

Nice to have:

• Experience of working in related sectors, for example RIM, product complaints.
• Technical skills (such as databases, SQL, XML) to support in project delivery.

About Ennov

Ennov is an independent software vendor (ISV) specialized in regulated content management for Life Science companies. With more than 20 years of experience serving the Pharmaceutical, Medical Device, Cosmetic, and Healthcare Industries, Ennov has over 800 clients worldwide, with 450+ in Life Sciences. Ennov is a 450-person company, with a global presence. With a strong technical culture, Ennov is proud of its values of innovation, pragmatism, and transparency in business relations. Enduring relationships with customers are the result.

Purdue Pharma L.P. and its subsidiaries develop, manufacture and market medications to meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians, and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications through internal research & development and strategic industry partnerships.

For close to two decades Purdue has engaged in many initiatives to stem prescription opioid abuse. We are committed to bringing lifesaving relief to communities and individuals suffering from substance use disorder and overdose. We are currently developing or supporting the development of two essential life-saving opioid overdose reversal medications and have the capability to manufacture others for medication assisted treatment. Providing these medicines has the potential to improve and save countless lives.

We are driven by our purpose:
Compassion for patients and excellence for science inspire our pursuit of new medicines.
We are building an exciting path forward, and we are committed to recruiting a dedicated team of professionals who advance our expertise through a commitment to Purdue's Values:
Integrity
and
Courage
, underpinned by
Innovation
, and always in
Collaboration
with each other.

At Purdue Pharma and our subsidiaries, you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work. We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We strive to create an environment where you can bring your best to work each day
.
We welcome the opportunity to have you on our team
Job Summary
Responsible for ensuring the Company's global pharmacovigilance (PV) system remains compliant with legal and regulatory requirements as both a Marketing Authorization Holder and a Clinical Trial Sponsor. Develop and deliver PV specific training, maintain systems to track and oversee compliance, monitor PV system performance, ensure timely and effective CAPA implementation, and support the development and maintenance of compliant procedures within the Quality Management System (QMS).

Primary Responsibilities

• Conduct regular gap analysis of the Company's PV system to ensure ongoing compliance with global regulatory pharmacovigilance requirements.
• Develop and propose new PV procedures, or IT systems and manage updates to existing ones as needed.
• Manage commitments with license partners to ensure mutual compliance with aggregate reporting requirements outlines in PV Agreements.
• Create, update, and implement PV in coordination with the Quality Department, ensuring timely rollout and related training.
• Oversee PV standards and procedures; ensure CAPAs are put in place and executed where needed.
• Develop systems – both procedural and electronic - to support oversight of the PV system, including KPI tracking and performance monitoring.
• Support internal and external PV audits and inspections, including preparations, participation and follow-up activities.
• Participate as an auditor in mock audits as needed.
• Provide input in annual PV Audit Plan and ensure ad-hoc updates are made as required.
• Review audit and inspection reports, identify areas in need of corrective and/or preventive actions, and ensure appropriate root cause analyses and CAPAs are documented and executed.
• Maintain audit trail of CAPA plans with PV relevance and create living overview of their status of executional progression and completion. Escalate overdue CAPAs or CAPAs at risk to the Executive Director and Head of Safety Operations.
• Advise on PV-related role-based training matrices; deliver PV training to organization and external vendors as requested.
• Ensure adequate documentation and proof of PV training for all relevant employees.
• Provide PV input into vendor and partner contractors (e.g. PSP, Market Research, social media screening projects, etc.) and maintain oversight of third-party compliance.
• Ensure that a living overview of such contracts is available to PV. Monitor compliance with third-party contracts, propose corrective or preventive actions as needed to restore or continue compliance.
• Oversee vendor performance and manage case medical review activities according to internal timelines.
• Support the team in monitoring changes and new developments to global regulatory pharmacovigilance requirements.
• Provide support in signaling, assessing and implementing the potential impact of such changes and new developments on the Company's PV system.
• Act as back-up for Vendor operations, assist with quality control of outsourced activities, and develop relevant operational metrics.
• Other duties as assigned.

Education And Experience Requirements

• Bachelor's degree in healthcare or life sciences required; Advanced degree, such as PharmD, RN or BSN highly desirable
• 5+ years of experience in pharmacovigilance quality and compliance monitoring; 3-4 years of direct experience in Pharmacovigilance Compliance, global setting preferred

Necessary Knowledge, Skills, And Abilities

• Strong knowledge of Food and Drug Administration (FDA), European Union (EU), and International Conference on Harmonization (ICH) guidelines
• Excellent verbal, written and interpersonal communication skills
• Ability to effectively problem solve and implement solutions
• Demonstrated good judgment with ability to influence without authority
• Critical and objective interpretation of business, scientific and commercial information
• Proven project management skills; good planning, analytical, and time management skills
• Ability to foster a strong, positive work culture and work constructively and collaboratively under pressure; Ability to work cross-functionally, build relationships and quickly gain credibility with business leaders

Supervisory Responsibilities (if Applicable)
N/A

We are an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance.

For more information about your rights under Equal Employment Opportunity, visit:

• EEOC Know Your Rights
• USERRA Rights
• Family and Medical Leave Act (FMLA)
• Employee Polygraph Protection Act (EPPA)
• E-Verify (English and Spanish)
• Right to Work (English and Spanish)

We strive to make our Career opportunities website accessible to all users. If you need an accommodation to participate in the application or hiring process, please email the Talent Acquisition team at

. This email is not for general employment inquiries or vendors; rather it is strictly for applicants who require assistance.

The Company does not seek or accept unsolicited resumes or CVs from recruitment agencies. We are not responsible for any fees, commission, or any type of payment related to unsolicited resumes or CVs except as required in a written agreement between the Company and the recruitment agency or party requesting payment of a fee.

Under certain state law, we may be required to provide a reasonable estimate of the salary range for the jobs covered by this description. Actual salary determinations will take into account factors such as work location, prior education or training and experience, job related knowledge, and demonstrated skills aligned with the Company's internal leveling guidelines and benchmarks. Resumes may be considered in the order they are received.

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
This position is a unique opportunity to combine both operational PV support and analytical PV support. This Director level PV Scientist will be responsible for clinical trial PV support for the assigned product including case oversight, signaling, aggregate report authoring, and creation/maintenance of core study documents such as ICFs, IBs, and protocols for PV. This individual will sit on core study teams, working in a cross-matrix environment, and is an individual contributor role.

Key Responsibilities

• You will work collaboratively with the medical monitor for timely review of SAEs, the development of analysis of similar events, and procurement of required follow-up information
• Ensure that all SAEs are reviewed, processed, and expedited in accordance with global regulations
• Project lead for signaling for assigned products including facilitation of cross-functional Safety Management Committee meetings including setting agendas, creating materials, presenting to the committee, and all associated documentation
• Provide PV subject matter expertise in all areas of clinical development including core study document development and maintenance (CRFs, ICF, protocols, IBs), regulatory requests for information, and safety crisis management
• Project lead and author on the annual Developmental Safety Update Reports
• Development and/or support of standard operating procedures (SOPs)

Qualifications

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV
• Minimum 8 years' pharmaceutical industry experience in PV
• Knowledge of MedDRA terminology and its application
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data
• Experience in the preparation and authoring of pre- and post- aggregate safety reports
• Thorough understanding of the drug development process and context applicable to safety surveillance activities
• Ability to execute and follow-through to completion and documentation
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
• Independently motivated, detail oriented and good problem-solving ability
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
• Excellent communication skills and ability to influence multiple functions
• Experience working on BLA/MAA filings is preferred

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $183,200 to $229,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas' competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.
Zenas BioPharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.

Mineralys Therapeutics is a publicly traded, clinical-stage biotechnology company focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Our initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that we are developing for cardiorenal conditions affected by abnormally elevated aldosterone, including hypertension and chronic kidney disease.

Mineralys is a fully remote company.

For more information, please visit Follow Mineralys on LinkedIn.

The Pharmacovigilance Scientist (PVS) is responsible for providing operational and scientific contributions to Drug Safety, Pharmacovigilance, and Risk Management activities related to the company's product portfolio. This role involves directly conducting safety activities, ensuring compliance with regulatory requirements, and supporting the preparation of safety reports and analyses.

Key Responsibilities

• Support the PV team in quality control review of individual case safety reports (ICSRs) to ensure accuracy, completeness, and regulatory compliance.
• Support the Identification and communication of discrepancies or trends in case processing and collaborate on corrective actions.
• Support and contribute to departmental SOPs and work instructions. Work closely with the Quality Assurance for the finalization of SOPs.
• Signal Detection and Management:
• Conduct regular signal detection activities using various data sources, including spontaneous reports, clinical trial data, and literature.
• Analyze data to identify potential safety signals and trends.
• Evaluate the clinical significance of identified signals and recommend appropriate actions.
• Prepare and present signal detection reports to safety committees and regulatory authorities.
• Maintain and update signal management plans and documentation.
• Coordinate and participate in Safety Management Team meetings and clinical study-level Safety Review Committee meetings.
• Coordinate and participate in Safety Management Team meetings and clinical study-level Safety Review Committee meetings.
• Contribute to the preparation of safety documentation for NDA submissions, including Integrated Summary of Safety (ISS), Summary of Clinical Safety and Risk Management Plan (RMP)
• Assist and contribute to safety sections of the Investigators Brochure and DSUR
• Assist in preparing and reviewing safety sections of clinical documents and responses to regulatory agency questions.
• Support audits and inspections related to pharmacovigilance activities.
• Maintain up-to-date knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, FDA, EMA).

Qualifications

• Bachelor's Degree in biologic or natural science, or health case discipline; or Advanced degree preferable (DDS, DMD, BDS, PhD, MPH, NP, PharmD, etc.) required.
• Minimum of 3 years of Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.

Required Skills

• Strong organizational skills, including the ability to prioritize independently with minimal supervision.
• Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes knowledge of case processing, expedited reporting rules, and safety database concepts.
• Strong knowledge of common data processing software and database systems such as Argus
• Expertise in safety data analysis and signal management. Ability to understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format
• Strong understanding of US and EU pharmacovigilance regulatory requirements.
• Ability to deliver high-quality reports and innovative solutions for aggregate safety
• Knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems.
• Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues.
• Applies clinical judgment to interpret case information.

• Process and evaluate incoming adverse event reports from various sources, including spontaneous reports, literature, and clinical studies.
• Perform medical coding of adverse events using standard medical terminology (e.g., MedDRA).
• Determine causality assessment for reported adverse events.
• Ensure compliance with global regulatory reporting requirements for safety data, including submission of aggregate reports and individual case safety reports (ICSRs).
• Maintain and manage the pharmacovigilance database, ensuring data integrity and accuracy.
• Collaborate with internal departments, including regulatory affairs, clinical operations, and medical affairs, to ensure consistent safety information.
• Participate in the development and maintenance of pharmacovigilance SOPs and work instructions.
• Assist in the preparation of safety-related documents for regulatory submissions.
• Stay updated on current pharmacovigilance regulations and guidelines.

• Bachelor's degree in a healthcare-related field (e.g., Pharmacy, Nursing, Life Sciences).
• Minimum of 3 years of experience in pharmacovigilance or drug safety.
• Strong understanding of global pharmacovigilance regulations (e.g., FDA, EMA).
• Proficiency with pharmacovigilance databases and electronic data capture systems.
• Excellent analytical and critical thinking skills.
• Exceptional attention to detail and accuracy.
• Strong written and verbal communication skills.
• Ability to work effectively both independently and as part of a collaborative team.

The Manager, Pharmacovigilance QA, provides quality assurance oversight and support of end-to-end Pharmacovigilance (PV) and Device Vigilance (DV) activities within Novartis to ensure compliance with applicable local and global regulatory requirements and Novartis procedures and quality standards.

This position will be located in East Hannover, NJ and has the ability to work remotely the majority of the time, with the ability to be on-site during inspection time.

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Major accountabilities:

• Support initiatives to maintain or improve quality performance and compliance of Novartis PV activities including case processing, medical safety, risk management, Health Authority reporting, PV IT systems and device vigilance. Champion the quality mindset.
• Support initiatives focused on quality, process, and compliance improvement. Through close collaboration with business partners, identify opportunities and develop strategies aimed at simplifying processes and improving quality while ensuring compliance with applicable regulatory requirements.
• Provide quality support of transition and integration-related activities for PV and Device Vigilance systems resulting from mergers, acquisitions, and/or divestments.
• Support maintenance of the Pharmacovigilance System Master File (PSMF).
• Support training initiatives as assigned.
• Provide quality support to PS&PV and other groups/business partners involved in PV and DV activities; assist with issue identification and root cause investigations; sign-off investigation reports.
• Support Health Authority Inspections, including inspection readiness activities, conduct, and follow-up.
• Guide the development of robust and sustainable corrective and preventative action plans (CAPA) in collaboration with the responsible groups performing PV and DV activities. Monitor status of corrective and preventative actions to ensure the issues are adequately addressed, completed, and appropriately documented.
• Ensure quality and regulatory compliance issues are promptly communicated to appropriate management. Support initiatives geared towards remediation of compliance concerns; determine effectiveness of remediation activities; provide ongoing project support and governance.
• Support activities to ensure the effective quality oversight, management, and support of global PV operational vendors. Support vendor quality awareness and improvement measures.

Key performance indicators:

• Effective coordination, facilitation, and follow-up of HA inspections
• DD, transition and integration activities completed in accordance with specified timelines
• Successful management of the PV-related actions of the GDD Quality Plan
• Timely escalation through proper channels of issues and findings that impact Novartis' PV, Patient Safety, and risk benefit evaluation capabilities
• Effective collaboration on quality, compliance, remediation, and improvement initiatives
• Timely review and feedback on policies, guidelines, and procedures
• Timely and effective communication, consultation, and support to business partners

Minimum Requirements:

Work Experience:

• A minimum of two years PV/PV quality and related pharmaceutical industry and/or Health Authority experience; Device vigilance experience a plus.
• PV auditing or inspection experience and Health Authority interactions a plus.
• Experience in maintenance of PV and/or device Quality Management Systems a plus.
• Ability to manage and objectively evaluate compliance issues with limited supervision; good problem solving, decision making and prioritization skills.
• Quality mindset.
• Good knowledge of PV regulations, guidelines, and policies; awareness of GCP and Part 11 requirements a plus.
• Ability to operate cross-functionally and in diverse cultural environments.

Skills:

• Agility.
• Analytical Development.
• Audit Management.
• Auditing.
• Business Partnering.
• Change Control.
• Continuous Learning.
• Health Authorities.
• Influencing Skills.
• Knowledge Of Capa.
• QA (Quality Assurance).
• Quality Management.
• Risk Management.
• Root Cause Analysis (RCA).
• Self-Awareness.
• Six Sigma.
• Sop (Standard Operating Procedure).
• Technological Expertise.

Languages:

• Excellent communication skills with good written and verbal command of English. Fluency in at least one other language is a plus.

Novartis Compensation and Benefit Summary:

The pay range for this position at commencement of employment is expected to be between $98,700 and $183,300/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Company will not sponsor visas for this position.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally:

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility & Reasonable Accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to (email protected) or call and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Division

Development

Business Unit

Universal Hierarchy Node

Location

USA

State

New Jersey

Site

East Hanover

Company / Legal Entity

U014 (FCRS = US014) Novartis Pharmaceuticals Corporation

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

About Tenpoint Therapeutics
Tenpoint Therapeutics is a global, commercial-ready biotechnology company focused on developing groundbreaking treatments to rejuvenate vision in the aging eye. Its pipeline includes paradigm-shifting therapeutics for ophthalmic indications with significant unmet medical need, including presbyopia, cataracts, and geographic atrophy.

Our lead investigational asset, BRIMOCHOL PF, is designed to be the first and only combination therapy for presbyopia and has received a Prescription Drug User Fee Act (PDUFA) date of January 28, 2026. We are actively advancing preparations for a commercial launch in the first half of 2026.

We know our people are the driving force behind the success of our mission and vision. That's why we offer a competitive benefit package to attract the very best talent to our team and to take care of our employees and their families. Below is a snapshot of our U.S. benefits package for full-time employees.

• Generous medical, dental, and vision health insurance plans
• Flexible spending accounts for health and dependent care
• Short-term, long-term, and life/AD&D insurance
• Employee Assistance Program
• 20 paid vacation days, 12 paid holidays, and 12 sick days
• 401(k) Retirement Plan with 100% company match up to 4% and immediate vesting
• Hybrid work options
• Wellness Resources
• Stock Options

For more information, visit and follow us on LinkedIn, X, and Instagram.

Role Overview
We're seeking an
*Executive Director of Pharmacovigilance (PV) *
to establish, lead, and oversee all PV activities at Tenpoint. This individual will be the company's sole internal PV expert and will partner closely with our third-party provider, to ensure compliant, effective pharmacovigilance systems and processes.

This is a rare opportunity to build PV capabilities in a growth-stage biotech on the cusp of commercialization, with direct impact on both patients and regulators' confidence in our products.

Key Responsibilities

• PV ownership: Serve as the single point of accountability for all pharmacovigilance activities across Tenpoint's pipeline and commercial portfolio.
• Third-party management: Oversee and manage third party PV vendor as Tenpoint's contract PV partner, ensuring quality, compliance, and alignment with business objectives.
• Procedure & process development: Establish and maintain internal PV policies, procedures, and processes that support regulatory compliance and organizational readiness.
• Regulatory compliance: Ensure adverse event reporting and pharmacovigilance operations meet FDA, EMA, ICH, and other applicable requirements.
• Cross-functional partnership: Collaborate with Clinical, Regulatory, Medical Affairs, and Commercial functions to integrate PV insights and support safe product development and commercialization.
• Safety leadership: Provide expert guidance on safety monitoring, signal detection, and risk management strategies.
• Executive engagement: Report PV activities, risks, and mitigation strategies directly to Tenpoint's leadership team, ensuring proactive decision-making.

Experience
*Required: *

• 12+ years in pharmacovigilance or drug safety, with demonstrated leadership at the Director/Executive Director level.
• Proven track record of managing PV through a contract organization, including oversight of external partners.
• MD strongly preferred; other advanced life sciences degrees will be considered with significant PV leadership experience.
• Ophthalmology experience is strongly preferred; candidates with relevant specialty experience in adjacent therapeutic areas will also be considered.
• Prior experience building PV functions in a startup or emerging biotech environment is highly desirable.
• Deep understanding of global PV regulations, compliance expectations, and reporting obligations.
• Exceptional communicator with the ability to present safety data and PV strategies clearly to technical and executive audiences.

Physical Requirements & ADA Statement

This role is primarily a desk-based job requiring the ability to operate a computer and communicate effectively in a remote work environment. The employee may be required to sit for extended periods, engage in video or phone meetings, and use standard office equipment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.

Looking for Pharmacovigilance (PV) Assessor/Analyst in Plainsboro, NJ (onsite)

ID - NNIJP

Must Haves:

1. Conducts data analysis to support quality assessment of key external vendor pharmacovigilance(PV) deliverables.

2. Education Level: Bachelor's degree required; advanced degree preferred

3. Analytical thinker with proficiency working with Tableau, Excel and other data analysis platforms

ROLE: Pharmacovigilance (PV) Assessor/Analyst

Job Requirements:

In-depth Data Review/Analysis, Interpretations and Communication:

• Conducts in depth review and data analysis to support quality assessment of external vendor/supplier compliance to contractual pharmacovigilance(PV) deliverables.

• Creates and deliver meaningful and insightful business performance updates

• Identifies nonconformance and performs risk assessments.

• Interprets and contextualizes analytical findings within the framework of project scope

• Conducts ad-hoc analyses to address emergent issues and in support of stakeholder/business unit needs.

Qualifications:

• Education Level: Bachelor's degree required; advanced degree preferred

• Experience Level: 3+ Years of analytical, external vendor/supplier auditing and reporting experience preferred, preferably in the pharmaceutical industry, PV and/or Patient Support

• Analytical thinker with proficiency working with Tableau, Excel and other data analysis platforms

• Able to communicate complex and disparate data in a clear and concise manner

• Able to create effective reports that present data in meaningful and cohesive manner

• Work independently with minimal managerial oversight and able to guide team members towards achieving business goals/object