Senior Medical Director, Immunology, Global Patient Safety

Role: Indication Product Safety Team (PST) Lead for immunology products, supporting safety strategy throughout product lifecycle, including surveillance, signal detection, and risk management. Responsibilities: analyze safety data, lead pharmacovigilance documentation (e.g., safety assessments, risk management plans, regulatory submissions), interpret regulations, and oversee safety reporting (DSURs, PSURs). Collaborate with cross-functional teams such as medical, regulatory, statistical science, and epidemiology to ensure patient safety and regulatory compliance. Qualifications: MD/DO with 2+ years patient management experience; 5+ years patient safety experience in pharma, including regulatory interactions and clinical development, preferably in immunology or internal medicine. Skills include data analysis, technical writing, cross-functional team leadership, and knowledge of pharmacovigilance regulations. High-Value: immunology, biologics/pharmaceuticals, safety surveillance, regulatory submissions, PV document strategy, and experience with NDA/sNDA processes. Work Setup: hybrid locations across US; no specific travel requirements specified.