Director, Drug Safety Physician

Role: Director, Drug Safety Physician at a clinical-stage biotech, supporting immunology antibody pipeline development. Responsibilities include case safety review, safety data monitoring, signal detection, safety strategy development, and contributing to clinical trial and regulatory documentation. The role involves cross-functional collaboration for pharmacovigilance processes, safety surveillance, and risk management, with contributions to safety presentations, literature reviews, and epidemiology projects. Requirements: MD with 6+ years in drug safety/medical review, proficiency in Argus, with experience in safety surveillance, signal detection, and global pharmacovigilance regulations (EMA, FDA). A degree or working knowledge in epidemiology is highly preferred. Experience in biotech/pharma, particularly with biologics or antibody therapies, is essential. High-value: immunology focus, biologics (antibodies), safety monitoring, signal detection, regulatory compliance, global pharmacovigilance. Work setup: remote with frequent in-person meetings; salary range $280K-$311K.