Director of Pharmacovigilance

• Director, Medical Safety Physician Product Lead
• Position Summary

The Director, Medical Safety Physician Product Lead provides medical leadership for assigned products within a global pharmacovigilance organization.

This role is responsible for benefit-risk assessment, signal detection, safety surveillance, risk management, regulatory safety strategy, and cross-functional leadership across the product lifecycle from early development through commercialization.

Key Responsibilities

• Serve as the medical safety lead for assigned products and development programs.
• Maintain oversight of product safety profiles and benefit-risk evaluations.
• Lead signal detection, safety surveillance, and risk management activities.
• Chair Safety Management Team (SMT) meetings and safety governance forums.
• Author and review key safety documents including DSURs, PSURs/PBRERs, RMPs, CCDS, Investigator Brochures, clinical protocols, and study reports.
• Provide strategic safety leadership for IND, NDA, BLA, and MAA submissions.
• Lead safety responses to health authorities and regulatory agencies.
• Partner with Clinical Development, Regulatory Affairs, Quality, Medical Affairs, and Commercial teams.
• Oversee safety labeling activities and ensure consistency across global product information.
• Provide medical oversight of ICSR review and aggregate safety analyses.
• Support clinical trial safety monitoring, database reconciliation, and review of safety data outputs.
• Act as pharmacovigilance representative on cross-functional product teams.
• Support inspections, audits, and health authority interactions as a subject matter expert.
• Mentor team members and contribute to process improvements across the global safety organization.

Qualifications

• MD or equivalent medical degree required.
• 7+ years of pharmacovigilance, drug safety, or medical safety experience within the pharmaceutical or biotechnology industry.
• Strong understanding of global pharmacovigilance regulations, including FDA and EU GVP requirements.
• Experience supporting clinical development programs and major regulatory submissions.
• Demonstrated expertise in signal detection, benefit-risk assessment, safety surveillance, and risk management.
• Experience authoring and reviewing aggregate safety reports and regulatory safety documents.
• Strong leadership, communication, and stakeholder management skills.
• Ability to work effectively in a global, matrixed environment.
• Preferred Qualifications
• Global product safety lead experience.
• Experience supporting products across multiple stages of development and commercialization.
• Background in epidemiology, biostatistics, or risk management.
• Experience leading regulatory inspections and health authority interactions.

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