Medical Director, Global Pharmacovigilance

About the role

The Drug Safety Medical Director leads medical activities within Global Pharmacovigilance, ensuring proactive safety surveillance and lifecycle risk management for assigned products. This senior position provides expert medical review of Individual Case Safety Reports (ICSRs), supports signal detection, and contributes to benefit‑risk assessments in line with global regulatory expectations.

Key responsibilities

• Serve as the Medical Reviewer for ICSR assessments, applying clinical judgment to determine causality and seriousness.
• Gather and evaluate scientific data to maintain and update Company Core Data Sheets (CCDS) and Core Safety Information (CCSI).
• Prepare medical safety content for regulatory submissions such as DSURs, PSURs/PBRERs, RMPs, and expert statements.
• Support safety signal detection and evaluation in partnership with PV scientists, delivering data‑driven recommendations.
• Author safety review documents, signal evaluation reports, and risk‑management recommendations for cross‑functional Safety Review Teams.
• Provide regulatory‑compliant responses to health‑authority safety 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

• Medical Doctor (M.D.) degree with at least 5 years of experience in pharmacovigilance, drug safety, or related fields.
• Minimum of 5 years of pharmaceutical or biotechnology PV experience, preferably with global exposure.
• Strong knowledge of FDA, EU, and ICH guidelines governing pharmacovigilance.
• Proven ability to assess ICSR data and contribute to aggregate safety reporting.

Required skills

• Pharmacovigilance and drug safety expertise
• Regulatory compliance (FDA, EU, ICH)
• Medical review of Individual Case Safety Reports
• Safety signal detection and evaluation