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