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