Vice President, Pharmacovigilance

Role: Vice President of Global Drug Safety & Pharmacovigilance, responsible for establishing and leading the company's pharmacovigilance strategy and operations to ensure patient safety. Key responsibilities include developing PV processes and SOPs, leading cross-functional safety governance, managing benefit-risk assessments, signal detection, and risk management, and overseeing safety data exchange with partners. The VP provides PV oversight for regulatory filings (IND/BLA/MAA), reviews safety reports (IBs, DSURs, CSR sections), and ensures compliance with global PV regulations. Additionally, the role involves chairing the executive safety review committee, overseeing PV team operations, and monitoring CRO performance. Qualifications required include MD with extensive clinical and industry experience, minimum 15 years in drug safety/pharmacovigilance, proven leadership in building high-performing teams, and deep knowledge of EMA/FDA/ICH regulations. Preferred skills encompass strategic decision-making and experience in biotech or pharmaceutical companies. This senior leadership role is critical for regulatory compliance and safety oversight across global markets.