Vice President, Pharmacovigilance

Role: Vice President of Global Drug Safety & Pharmacovigilance, leading the company's PV strategy and operations to ensure patient safety. Responsibilities include developing PV processes, policies, and systems; leading governance, benefit-risk assessments, signal detection, and risk management; chairing safety review committees; overseeing safety data exchange and regulatory submissions (IND/BLA/MAA), including clinical overviews, ISS, and RMPs; reviewing safety documents like IBs, DSURs, and CSR sections; leading medical review of ICSRs; monitoring CRO performance; and managing PV team hiring, training, and performance. Qualifications: MD with clinical and industry PV experience, minimum 15 years in drug safety roles within biotech or pharma; proven leadership in building and managing high-performing PV teams; deep knowledge of global PV regulations (EMA, FDA, ICH); strategic decision-making abilities. High-Value: senior PV leadership, global regulatory compliance, IND/BLA/MAA filings, safety data analysis, CRO oversight. WorkSetup: not specified.