Director, Global Drug Safety & Pharmacovigilance Physician (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

Director, Global Drug Safety & Pharmacovigilance Physician (MD)

Oncology | MD Required | Global Safety Leadership Location: Princeton, NJ | Hybrid (3x a week)

The Opportunity

We are partnering with a leading global biotechnology organization focused on the discovery and development of differentiated antibody-based medicines for patients with cancer and other serious diseases.

The organization has built a broad oncology portfolio spanning hematologic malignancies and solid tumors, with programs across early and late-stage clinical development. Its current pipeline includes Phase 3 programs across DLBCL, follicular lymphoma, head and neck squamous cell carcinoma, colorectal cancer, ovarian cancer and endometrial cancer, alongside earlier-stage programs in additional hematologic and solid tumor indications. Pipeline

This is an exciting opportunity for an accomplished MD-trained Drug Safety / Pharmacovigilance Physician to provide medical and safety leadership across the lifecycle of oncology products while working closely with clinical development, regulatory and other global cross-functional stakeholders.

The position will play an important role in safety strategy, benefit-risk assessment, regulatory submissions and interactions with global health authorities.

Key Responsibilities

• Lead major pre- and post-marketing safety activities, including signal evaluation, benefit-risk assessment and risk-management activities for assigned products.
• Provide medical leadership for ongoing safety surveillance, including the assessment of individual and aggregate adverse events and relevant scientific literature.
• Identify and evaluate emerging safety issues and contribute to appropriate risk-mitigation strategies.
• Prepare and provide medical input into key regulatory and clinical documents, including benefit-risk sections, aggregate safety reports, submission Module 2.7.4 safety summaries and clinical overviews.
• Contribute safety expertise to clinical trial protocols, amendments, clinical trial reports, CRFs/eCRFs and trial documentation.
• Collaborate closely with multidisciplinary global development teams to communicate and manage changes to product safety profiles.
• Engage directly with regulatory authorities, including activities associated with regulatory inspections and audits.
• Participate in and lead safety-related forums, including Safety Committees and external Data Monitoring Committees.
• Provide safety guidance and education to cross-functional stakeholders, CROs and investigators.
• Mentor colleagues and provide leadership on evolving pharmacovigilance regulations, technologies and best practices.

Required Qualifications

This is a physician-level position. An MD is required.

The successful candidate should bring:

• MD degree required
• 10+ years of Drug Safety / Pharmacovigilance experience across clinical development and/or post-marketing environments, with oncology experience strongly preferred.
• Demonstrated experience supporting BLA and/or NDA submissions.
• Strong understanding of the safety components required to support successful regulatory submissions.
• Direct experience interacting with the FDA and/or other global regulatory authorities.
• Active experience supporting regulatory authority inspections and PV audits.
• Strong understanding of the global pharmacovigilance regulatory environment, including relevant regulations, standards, initiatives and GVP.
• Experience with benefit-risk evaluation, signal management, aggregate safety reporting and medical review of individual adverse-event cases.
• Familiarity with MedDRA and WHODrug coding dictionaries and safety database environments.
• Ability to operate as a senior medical safety expert across global and cross-functional development teams.
• Experience guiding, mentoring and developing colleagues.

Ideal Profile

This opportunity is particularly well suited to an established Drug Safety / Pharmacovigilance Physician who combines deep medical judgment with strong regulatory experience.

The ideal candidate will have operated in oncology drug development, contributed directly to BLA/NDA submissions, and have credibility engaging with health authorities on complex safety topics. They should be comfortable serving as a senior safety voice on cross-functional development teams while remaining close to the scientific and medical evaluation of safety data.

Compensation & Benefits

For U.S.-based candidates, the stated base salary range for the position is:

$270,000-330,000 base, 25% bonus, LTI (60%)

Actual compensation will take into consideration qualifications, experience, skills and location.

Why Consider This Opportunity?

This role represents an opportunity to join a science-driven global biotechnology environment where oncology safety, regulatory strategy and clinical development intersect.

For an MD with deep oncology pharmacovigilance expertise, particularly someone who has already navigated BLA/NDA submissions and direct regulatory authority interactions, the position provides exposure to a diverse portfolio of investigational medicines across both hematologic and solid tumor indications.