Associate Director, Patient Safety Scientist

Role: Associate Director, Patient Safety Scientist, serving as a strategic partner in pharmacovigilance to evaluate and mitigate drug safety risks throughout product lifecycle, supporting both development and post-marketing stages. Responsibilities: lead core signal detection activities, evaluate safety data, prepare safety documentation (e.g., DSUR, PBRER), contribute to clinical trial safety planning, and support regulatory safety submissions. Drive risk management strategies, including creation and maintenance of Risk Management Plans (RMPs) and pharmacovigilance activities, in collaboration with global teams. Lead or support safety sections of trial documents, safety strategy for regulatory filings, and post-marketing safety updates. Oversee safety data review meetings, ensure regulatory compliance, and promote process improvements via automation and digital tools. Collaborate across functions such as Medical Safety Assessment, Clinical Development, Regulatory, and Epidemiology, and support audit preparedness. Qualifications: scientific degree (BS, MS, RN, PharmD, PhD, MD) with at least 6 years of pharmacovigilance or drug development experience; ability to mentor; deep knowledge of safety surveillance, signal detection, risk management, and regulatory requirements. High-value specifics: focus on biologics or small molecules in development or post-approval, with responsibilities spanning safety data review, signal management, regulatory submission support, and risk minimization. Work setup may include hybrid or onsite presence, with some travel. Emphasizes cross-functional collaboration, digital innovation, and strategic leadership in patient safety.