Executive Director, Pharmacovigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and implement all pharmacovigilance (PV) activities for Phase 3 and registration of biologics programs, ensuring adherence to ICH E2A, E2B, E2C, E2D, and E2E guidelines, as well as FDA, EMA, and other relevant regional regulations.

• Supervise global signal detection, evaluation, and management activities, including the review of Medical Dictionary for Regulatory Activities (MedDRA) coding and updates to benefit-risk assessments.

• Manage and enhance workflows for the receipt, processing, and reporting of safety data, collaborating with CROs, data management teams, and clinical operations.

• Act as the subject-matter expert and primary point of contact for PV within cross-functional clinical teams, regulatory affairs, and medical affairs.

• Maintain and uphold the company’s global safety database and infrastructure for adverse event reporting, including management of vendor relationships.

• Author and/or oversee the creation of Integrated Safety Summaries (ISS) and Integrated Summaries of Efficacy (ISE) for BLA and MAA submissions (as a member of the submission team), ensuring scientific integrity, internal consistency, and full compliance with regulatory standards (21 CFR 314.50, Module 2.7.4, ICH E3, ICH M4E).

• Supervise the comprehensive safety labeling strategy for biologics, ensuring compliance with FDA, EMA, and other global regulatory standards for products with boxed warnings, Risk Evaluation and Mitigation Strategies (REMS), restricted access programs, and other post-marketing risk mitigation requirements.

• Lead the preparation of Clinical Study Report (CSR) safety sections for Phase 2 and Phase 3 studies, including narrative composition, adverse event tabulations, and laboratory data evaluations.

• Prepare and manage Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs) according to global timelines.

• Develop Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS), including strategy formulation and implementation.

• Address inquiries and requests for safety information from health authorities during regulatory review processes (e.g., Complete Response Letters, Day 120/180 questions).

⛳️ Requirements

• A Doctor of Medicine (MD) degree from an accredited institution is necessary.

• A minimum of 12 years of progressive experience in pharmacovigilance within the pharmaceutical/biotech industry, including at least 5 years in a senior role with direct responsibility for late-phase global biologics PV programs.

• Proven experience in authoring Integrated Safety Summaries (ISS) submitted in at least one BLA or MAA; experience with multiple submissions is highly preferred.

• Extensive background in authoring CSR safety sections, DSURs, and PSURs/PBRERs for biologic compounds in global development.

• Strong knowledge of ICH guidelines (E2A–E2E, E6, E8, M4E), FDA/CDER and EMA/EMA GVP Module requirements, as well as regional pharmacovigilance regulations (EU, US, Japan, and other ICH regions).

• Extensive experience with signal detection methodologies, benefit-risk assessment frameworks, and safety narrative preparation.

• A proven history of managing CRO/vendor PV relationships and overseeing safety databases (Argus, ARISg, or equivalent).

• Experience in small biotech or startup settings is desirable; must be comfortable working with limited infrastructure and high personal accountability.

• Experience with BLA or MAA approval for a biologic; post-approval PV experience is an added advantage.

• Familiarity with rare disease, orphan drug, or first-in-class biologic programs.

• Experience presenting to Health Authorities (FDA, EMA) and participating in Advisory Committee proceedings.

• Understanding of REMS design and implementation or EU RMP preparation.

• Knowledge of pharmacoepidemiology methodologies and real-world evidence applications in safety assessments.

• Exceptional skills in scientific and medical writing; proven ability to synthesize complex safety data into clear, structured regulatory documents under tight deadlines.

• Strong analytical and critical thinking abilities; capacity to independently assess complex safety signals and provide evidence-based recommendations.

• High scientific credibility with the capability to engage and challenge clinical, statistical, and regulatory colleagues at a peer level.

• Excellent project management skills; adept at managing multiple competing priorities without compromising quality.

• Demonstrated leadership and crucial cross-functional collaboration skills.

🏝️ Benefits

• Work from a home office environment.

• Opportunities for domestic and international business-related travel (estimated 10–20%).

• ADA: The employer will provide reasonable accommodations in accordance with the Americans with Disabilities Act of 1990.