Associate Medical Director, Pharmacovigilance

Role: Medical Director/Medical Reviewer in Pharmacovigilance at a biotech focused on precision oncology. Primary responsibilities include medical assessment of Individual Case Safety Reports (ICSRs) from clinical trials, literature, and other sources, ensuring accuracy, causality, and compliance; authoring safety narratives; escalating significant safety issues; and providing vendor oversight and guidance. Qualifications: MD/DO or equivalent with 4+ years in pharmacovigilance, clinical research, or drug safety; 2–5 years hands-on ICSR review experience preferred. Skills: strong clinical judgment, familiarity with ICH, GVP, FDA/EMA regulations, MedDRA coding, and safety surveillance; excellent communication and cross-functional collaboration. High-value specifics: focus on drug safety in biotech environment, regulatory compliance, vendor management, and safety data quality. Work setup: not specified.