Associate Director, Safety Data Sciences

Role: Pharmacovigilance scientist responsible for safety surveillance activities throughout the product lifecycle, including signal detection, evaluation, and safety data review. Responsibilities: analyze safety data from clinical trials, literature, and databases; develop and communicate risk assessments to inform risk minimization strategies such as label changes; prepare safety sections of regulatory documents and safety summaries for internal and external stakeholders; lead safety-related initiatives and ensure compliance with pharmacovigilance regulations. Requirements: degree in Health Sciences (e.g., Pharmacy, Epidemiology, Nursing); 4+ years of clinical or safety experience with a Bachelor’s, or 2+ years with a Master’s/Doctorate (e.g., PharmD, PhD, MPH); strong knowledge of drug development, safety assessment tools, and regulatory standards; proficient in Microsoft Word and Excel; effective communicator capable of managing multiple projects independently. High-Value: primary focus on product safety and benefit-risk analysis, supporting global regulatory safety activities; cross-functional collaboration with clinical and safety teams; experience with biologics, small molecules, or targeted therapies preferred; GxP, PV regulations, and clinical trial safety monitoring essential. Work Setup: location flexible (multiple US hubs), no specific travel requirements mentioned.