Lead Medical Director, Drug Safety

Lead Medical Director, Drug Safety About the Company A renowned biopharmaceutical company dedicated to pioneering healthcare solutions. Industry Biotechnology Type Privately Held, Private Equity-backed About the Role We are seeking a highly experienced Lead Medical Director for Drug Safety to join our team. In this pivotal role, you will take charge of evaluating and interpreting safety data from a variety of sources, including clinical trials and reporting systems. Your medical expertise will be crucial in shaping safety reports, managing a team of committed medical safety professionals and pharmacovigilance scientists, and ensuring compliance with all drug safety regulations and standards. You will oversee effective safety surveillance processes, develop comprehensive risk management plans, and provide training to team members on safety and pharmacovigilance best practices. Ideal candidates will possess a Medical Degree (MD) and bring at least 8 years of solid experience in drug safety or pharmacovigilance within the pharmaceutical, biotech, clinical research organization (CRO), or regulatory agency sectors. This role necessitates a profound understanding of US and EU drug safety regulations, CIOMS, and ICH guidelines, along with a successful track record in leading teams of medical professionals and pharmacovigilance scientists. You must have proficiency in reviewing safety data, including Individual Case Safety Reports (ICSRs) and aggregate reports. The perfect candidate will demonstrate a strong history of effective safety data collection, analysis, and responding to regulatory authorities. Exceptional leadership, communication, and problem-solving skills are vital, as you will need to excel in a dynamic, fast-paced environment. Hiring Manager Title SVP, Global PV & Risk Management Travel Percent Less than 10% Functions Medical Care/Hospital Administration

Created: 2026-03-11