Vice President, Pharmacovigilance

Role: Vice President of Global Drug Safety & Pharmacovigilance, leading the pharmacovigilance strategy and operations to ensure patient safety for company products. Responsibilities: develop PV processes and policies, oversee safety data exchange, lead signal detection, benefit-risk assessments, and risk management; chair safety review committees; oversee safety documentation for regulatory filings (IND/BLA/MAA), review safety reports, and ensure PV compliance; monitor CRO performance; recruit, develop, and lead PV staff. Requirements: MD with clinical and industry experience; at least 15 years in drug safety/pharmacovigilance within biotech/pharma; proven leadership in high-performing teams; expert knowledge of global PV regulations (EMA/FDA/ICH). High-Value: senior leadership, pharmacovigilance strategy, global regulatory compliance, cross-functional collaboration with clinical development, safety data oversight. Work Setup: not specified.