Medical Director, Global Pharmacovigilance

Job description

Job Description Summary The Drug Safety Medical Director works within Drug Safety & Risk Management in Global Pharmacovigilance, providing medical leadership across proactive safety surveillance and lifecycle risk management activities. The role focuses on medical review of Individual Case Safety Reports (ICSRs), safety signal detection and evaluation, and benefit-risk assessment of the assigned products in alignment with global regulatory requirements. The Medical Director partners closely with Pharmacovigilance Scientists and cross functional stakeholders to ensure timely, medically sound, and data driven safety decisions throughout clinical development and post marketing phases. Job Description: Primary responsibilities: Serves as Medical Reviewer for Individual Case Safety Reports (ICSRs), providing expert medical assessment and clinical judgment. Gathers, reviews, and evaluates scientific and clinical data to support the development, maintenance, and update of Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI). Prepares and contributes medical safety content for key regulatory documents, including but not limited to, Development Safety Update Reports (D...