Vice President, Global Pharmacovigilance
Sarepta Therapeutics
June 26, 2026
Remote friendly (Cambridge, MA)
United States
Medical Affairs
The Vice President, Global Pharmacovigilance will be responsible for the strategic global implementation, execution, and management of Pharmacovigilance and risk management activities in conjunction with the Company’s development and commercial activities, industry standards, and compliance with global regulations. Provide medical oversight for pharmacovigilance, drug safety, and risk management for investigational and marketed products, ensuring proactive and timely risk-benefit assessments of safety data.
Responsibilities:
- Oversee pharmacovigilance and risk management for investigational compounds and marketed products; participate in oversight of patient safety in clinical trials.
- Design and conduct ongoing safety surveillance using internal/external resources (e.g., CROs) to deliver high-quality pharmacovigilance services.
- Negotiate contracts and manage CROs/consultants; provide senior management updates on evolving risk-benefit profiles and implement safety updates/risk mitigation plans.
- Plan, implement, and manage drug safety activities supporting clinical development.
- Oversee clinical safety activities, including review of AE/con-med coding and processing of SAEs; prepare analyses of similar events (ASE) for unexpected/related serious adverse events (SUSARs).
- Respond to and resolve safety questions from regulators; lead regulatory audits/inspections and corrective action plans.
- Ensure development and compliance of periodic/annual safety reports (e.g., DSUR, PSUR), investigator communications, and safety-related label/package insert updates.
- Provide medical expert safety input into critical development documents (protocols/amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
- Ensure departmental budgets/schedules meet corporate requirements.
- Manage internal staff and external contractors; select, train, develop, and evaluate teams.
- Monitor global safety regulations and best practices; recommend updates to policies/SOPs/systems for regulatory compliance.
Qualifications:
- M.D. in health sciences preferred.
- Clinical expertise in rare disease preferred.
- 10+ years progressive Drug Safety experience in biotech or pharmaceutical company (required).
- Expert knowledge: FDA safety regulations, ICH Guidelines, EU GVP, and global safety regulations.
- Knowledge of U.S. and international product safety reporting requirements and clinical development process.
- Expert knowledge of safety database tools (e.g., ARGUS, ARISg).
- Expertise in clinical safety assessments, safety signal detection, and risk management with regulatory interactions.
- Strong leadership, written/verbal/presentation skills, collaboration, and strategic decision-making.
Application instructions:
- Apply if you are solution-oriented, comfortable with ambiguity and candor, and prioritize kindness and integrity.
Responsibilities:
- Oversee pharmacovigilance and risk management for investigational compounds and marketed products; participate in oversight of patient safety in clinical trials.
- Design and conduct ongoing safety surveillance using internal/external resources (e.g., CROs) to deliver high-quality pharmacovigilance services.
- Negotiate contracts and manage CROs/consultants; provide senior management updates on evolving risk-benefit profiles and implement safety updates/risk mitigation plans.
- Plan, implement, and manage drug safety activities supporting clinical development.
- Oversee clinical safety activities, including review of AE/con-med coding and processing of SAEs; prepare analyses of similar events (ASE) for unexpected/related serious adverse events (SUSARs).
- Respond to and resolve safety questions from regulators; lead regulatory audits/inspections and corrective action plans.
- Ensure development and compliance of periodic/annual safety reports (e.g., DSUR, PSUR), investigator communications, and safety-related label/package insert updates.
- Provide medical expert safety input into critical development documents (protocols/amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
- Ensure departmental budgets/schedules meet corporate requirements.
- Manage internal staff and external contractors; select, train, develop, and evaluate teams.
- Monitor global safety regulations and best practices; recommend updates to policies/SOPs/systems for regulatory compliance.
Qualifications:
- M.D. in health sciences preferred.
- Clinical expertise in rare disease preferred.
- 10+ years progressive Drug Safety experience in biotech or pharmaceutical company (required).
- Expert knowledge: FDA safety regulations, ICH Guidelines, EU GVP, and global safety regulations.
- Knowledge of U.S. and international product safety reporting requirements and clinical development process.
- Expert knowledge of safety database tools (e.g., ARGUS, ARISg).
- Expertise in clinical safety assessments, safety signal detection, and risk management with regulatory interactions.
- Strong leadership, written/verbal/presentation skills, collaboration, and strategic decision-making.
Application instructions:
- Apply if you are solution-oriented, comfortable with ambiguity and candor, and prioritize kindness and integrity.