Director, Medical Safety

Role: Director of Medical Safety within Drug Safety & Pharmacovigilance, responsible for leading a team of PV scientists to ensure high-quality safety surveillance throughout the product lifecycle. Objectives include signal detection, risk management, aggregate safety reporting, and supporting clinical development and post-marketing safety activities. Responsibilities encompass overseeing signal detection, managing Risk Management Plans, authoring safety reports, providing benefit-risk assessments, and ensuring compliance with global pharmacovigilance regulations (FDA, EMA, ICH). The role involves strategic collaboration with Medical Safety Physicians, Clinical Development, Regulatory Affairs, and Data Management, with a focus on integrating AI-enabled tools to optimize pharmacovigilance workflows. Requirements: Master’s or PhD in Pharmacy, Pharmacology, Life Sciences, or related field; 10+ years in pharma/biotech, including 5+ years leading PV teams; experience supporting clinical and post-marketing safety activities; expertise in signal detection, benefit-risk assessment, and safety report preparation; solid understanding of global PV regulations. Preferred: experience in pulmonary, rare diseases, or gene therapy; familiarity with safety data visualization and global PV initiatives; advanced scientific degrees are a plus. This is a fully remote role with occasional travel (~15%) and offers a comprehensive benefits package. High-value specifics include leadership in pharmacovigilance, global regulatory compliance, AI technology integration, and support across clinical and post-marketing phases in a biopharma setting.