Drug Safety Physician

Drug Safety Physician - West Coast Remote Role Overview: We are seeking a seasoned medical professional to lead drug safety and pharmacovigilance initiatives across clinical development and marketed products. This role involves evaluating safety data, overseeing risk management, and ensuring compliance with global regulations. The Director will collaborate with cross-functional teams to support high-quality safety programs and regulatory submissions. Key Responsibilities: • Review and assess adverse events from clinical trials, post-marketing reports, and literature. • Lead safety data analysis, signal detection, and risk–benefit assessments. • Contribute to safety-related documents and regulatory submissions. • Support safety governance, including safety review meetings and oversight committees. • Provide clinical input on risk management strategies, labeling, and safety plans. • Serve as a medical liaison with regulatory authorities, including FDA and EMA, on safety matters. • Partner with internal teams to ensure consistent, compliant, and proactive safety practices. • Interact with FDA and EMA Qualifications: • Medical degree (MD, or equivalent); relevant board certification preferred. • 6+ years of experience in pharmacovigilance/drug safety within the biopharmaceutical industry. • Strong knowledge of global safety regulations and guidance (FDA, EMA, ICH). • Experience in adverse event evaluation, signal detection, and safety reporting. • Proven ability to collaborate across clinical, regulatory, and medical affairs teams. • Excellent analytical and communication skills. • Experience in rare diseases or specialty therapeutics is a plus.