Medical Director, Global Pharmacovigilance

About the role

The Drug Safety Medical Director leads Global Pharmacovigilance activities, providing medical oversight for safety surveillance and lifecycle risk management of assigned products. The role ensures medically sound, data‑driven decisions throughout clinical development and post‑marketing phases.

Key responsibilities

• Serve as Medical Reviewer for Individual Case Safety Reports (ICSRs), delivering expert clinical judgment.
• Gather and evaluate scientific data to maintain Company Core Data Sheets (CCDS) and Core Safety Information (CCSI).
• Prepare medical safety content for regulatory documents such as DSURs, PSURs/PBRERs, RMPs, and expert statements.
• Support safety signal detection and evaluation in partnership with PV scientists.
• Author safety review documents, signal evaluation reports, and recommend risk‑management actions.
• Provide medical expertise for regulatory responses to health‑authority queries.
• Act as Subject Matter Expert on ICH, EU, US, and international pharmacovigilance regulations.
• Participate in special projects and assignments as business needs evolve.

Required profile

• MD degree with at least 5 years of pharmacovigilance or drug‑safety experience.
• Minimum 5 years in pharmaceutical/biotechnology PV, preferably with global exposure.
• Strong knowledge of FDA, EU, and ICH guidelines governing pharmacovigilance.
• Proven ability to assess Individual Case Safety Reports and conduct signal evaluation.

Required skills

• Pharmacovigilance
• Drug safety
• Regulatory guidelines (FDA, EU, ICH)
• Signal detection and evaluation
• Medical review of ICSR data