Sr. Medical Director, Drug Safety & Pharmacovigilance

Role: Senior Medical Director, Drug Safety & Pharmacovigilance, responsible for safety strategy and risk management throughout drug development and post-market. Core responsibilities include leading signal detection, safety data review, risk-benefit assessments, overseeing safety committees, and providing medical safety input for regulatory documents. Collaborates closely with cross-functional teams, vendors, and internal safety scientists to ensure compliance and high-quality safety oversight. Qualifications: MD, MBBS, MD-PhD, or equivalent; minimum 5 years in pharmaceutical drug safety and pharmacovigilance. Required skills include comprehensive knowledge of US/EU pharmacovigilance regulations, experience supporting safety in clinical trials, and familiarity with regulatory submissions (INDs, NDAs/BLA). High-value specifics: experience with registrational clinical studies, regulatory interactions, and post-marketing surveillance; strong leadership and communication skills; ability to influence cross-functional teams. Work setup and travel details are not specified.