Senior Medical Director, PVRM

Sumitomo Pharma is hiring a Senior Medical Director, PVRM to join our team in Trenton, Mercer County, in a full-time, on-site role shaping the safety profile of medicines that improve patients' lives across multiple therapeutic areas.

About the Role

As Senior Medical Director, PVRM (Pharmacovigilance and Risk Management), you will provide medical and scientific leadership for the safety surveillance of marketed products and investigational assets at Sumitomo Pharma. Based in Trenton, Mercer County, you will serve as a trusted safety authority, guiding benefit-risk assessment and ensuring that patient protection remains central to every decision throughout a product's lifecycle.

Key Responsibilities

• Lead the medical evaluation of safety signals and own benefit-risk assessments across the portfolio.
• Author and review core safety documents, including risk management plans, periodic safety reports, and signal evaluations.
• Partner with clinical development, regulatory affairs, and cross-functional teams on safety strategy and study design.
• Represent pharmacovigilance in interactions with health authorities and contribute to regulatory submissions.
• Provide medical oversight of individual case safety reports and aggregate safety data.
• Mentor colleagues and help advance the standards and practices of the PVRM function.

Qualifications

• Medical degree (MD or equivalent), with a strong clinical and scientific foundation.
• Substantial experience in pharmacovigilance, drug safety, or risk management within the pharmaceutical or biotechnology industry.
• Working knowledge of global safety regulations and benefit-risk methodology.
• Proven ability to interpret complex safety data and communicate clear, well-reasoned conclusions.
• Collaborative leadership style with experience guiding cross-functional and multidisciplinary teams.
• Willingness to work on-site in Trenton, Mercer County (this position is not remote).

About Sumitomo Pharma

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company headquartered in Japan, with U.S. operations conducted through Sumitomo Pharma America, Inc. We focus on meeting unmet patient needs across oncology, urology, women's health, rare diseases, cell & gene therapies, and central nervous system (CNS) disorders. With several marketed medicines and a diverse pipeline spanning early- to late-stage investigational assets, our mission is to accelerate discovery and research that delivers meaningful therapies to patients worldwide.

How to Apply

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