Senior Medical Director, Pharmacovigilance

Role: Senior Medical Director, Pharmacovigilance, overseeing global drug safety activities for marketed and investigational products. Primary objectives include leading benefit-risk assessments, safety surveillance, signal detection, and regulatory safety documentation. Responsibilities encompass medical review of adverse events, contributing to safety-related study documentation, and participating in regulatory interactions and safety committees. Requirements include an MD (board certified preferred), 10+ years in pharmacovigilance or drug safety within pharma, biotech, or CROs, with a strong scientific/clinical background and understanding of global safety regulations. Preferred skills involve expertise across therapeutic areas, proficiency with pharmacovigilance systems (e.g., Argus, ARISg), digital tools, and project management capabilities. The role demands leadership in risk management, safety data interpretation, and cross-functional collaboration with Clinical Development, Medical Affairs, and Regulatory teams. High-value details include focus on benefit-risk evaluation, safety reporting (e.g., PSUR, DSUR), and safety in clinical trial contexts. The position may involve managing safety aspects of multiple products throughout their lifecycle, with a strong emphasis on regulatory compliance, data analysis, and safety science. Work setup details are not specified. Overall, the role targets an experienced pharmacovigilance leader capable of strategic safety oversight in a global biopharma environment.