Global Oncology Drug Safety & Pharmacovigilance Director (MD)

EPM Scientific; Princeton (NJ); Hybrid; USD 270,000 - 330,000; Full time

Job summary

EPM Scientific is seeking a Director, Global Drug Safety & Pharmacovigilance Physician (MD) in Princeton, NJ. Hybrid work arrangement (3x a week) with oncology safety leadership across the product lifecycle.

The role requires MD with 10+ years in Drug Safety/PV, strong regulatory experience, and direct engagement with health authorities. Lead safety strategy and regulatory submissions for hematologic and solid tumor programs.

Qualifications

• MD degree required.
• 10+ years of Drug Safety / Pharmacovigilance experience, oncology preferred.
• Experience supporting regulatory submissions (BLA/NDA).
• Direct FDA/global regulatory authority interactions desired.

Responsibilities

• Lead major pre- and post-marketing safety activities including signal evaluation and risk management.
• Provide medical leadership for safety surveillance and literature assessment.
• Identify emerging safety issues and contribute to risk mitigation strategies.
• Prepare input into regulatory documents including safety summaries and clinical overviews.
• Contribute safety expertise to clinical trial protocols and trial documentation.
• Collaborate with global cross-functional teams to manage safety profiles.
• Engage with regulatory authorities including inspections and audits.
• Lead safety forums and committees.
• Provide safety guidance to CROs and investigators.
• Mentor colleagues on PV regulations and best practices.

Skills

Medical leadership

Regulatory interactions

PV expertise

Cross-functional collaboration

Education

MD degree

Job description

EPM Scientific is seeking a Director, Global Drug Safety & Pharmacovigilance Physician (MD) in Princeton, NJ. Hybrid work arrangement (3x a week) with oncology safety leadership across the product lifecycle.

The role requires MD with 10+ years in Drug Safety/PV, strong regulatory experience, and direct engagement with health authorities. Lead safety strategy and regulatory submissions for hematologic and solid tumor programs.