Senior Medical Director, Patient Safety & Pharmacovigilance

Onsite 4 days a week - San Francisco, CA MD Oncologist - Board certified or eligible required Senior Medical Director, Patient Safety & Pharmacovigilance A growing clinical-stage oncology biotech is seeking an experienced physician leader to oversee patient safety and pharmacovigilance activities across its development portfolio. This individual will play a key leadership role driving safety strategy, signal management, benefit-risk assessments, and cross-functional collaboration within a fast-paced environment. Key Responsibilities: • Lead safety strategy and signal detection activities across oncology programs • Oversee global pharmacovigilance deliverables including DSURs, PSURs/PBRERs, IND Annual Reports, and regulatory safety documentation • Provide medical oversight for protocols, Investigator’s Brochures, ICFs, and risk management activities • Partner closely with Clinical Development, Regulatory, and external health authorities • Lead Safety Review Committee activities and support regulatory submissions including INDs and NDAs • Mentor and manage safety physicians/scientists while helping drive compliant PV operations and processes • Conduct medical review of SAEs and support overall safety governance initiatives Qualifications: • M.D. or D.O. with completed residency training required • 8+ years of pharmacovigilance/drug safety experience, ideally within oncology biotech/pharma • Strong knowledge of FDA, EMA, ICH, and global PV regulations • Proven leadership and cross-functional collaboration experience in fast-paced development environments