Associate Director, Global Drug Safety & Pharmacovigilance Scientist

Role: Associate Director of Drug Safety and Pharmacovigilance at Genmab, based in Princeton, responsible for global drug safety activities in oncology. Objectives include developing safety strategies, performing signal detection and safety surveillance for clinical trials and post-marketing data, and ensuring regulatory compliance. Responsibilities encompass reviewing safety data, contributing to safety documentation (e.g., DSUR, PBRER, RMP), supporting safety committees, conducting safety training, and overseeing safety-related vendor activities. Qualifications: healthcare professional degree (RN/BSN/MSN, NP, PA, PharmD) with 5+ years’ experience in drug safety/pharmacovigilance, preferably within oncology, with expertise in signal detection, safety reporting, and international regulatory standards (FDA/EMA, ICH). Skills include managing safety databases (Argus preferred), authoring safety assessments, and strong communication. High-Value: oncology, clinical and post-marketing safety, signal detection, regulatory compliance, global stakeholder interaction. Work setup: primarily office-based in Princeton with collaboration across international teams.