Manager, PVRM

Join Sumitomo Pharma America as Manager, PVRM in Marlborough, Middlesex County, Massachusetts. This full-time leadership role sits at the center of our patient safety mission, overseeing pharmacovigilance and risk management across our diverse portfolio of marketed products and investigational therapies in oncology, urology, women's health, rare diseases, cell & gene therapy, and CNS.

About the Role

As Manager, PVRM, you'll drive the strategic development and execution of pharmacovigilance risk management initiatives. This role combines regulatory expertise with operational leadership, ensuring our therapeutic programs maintain the highest safety standards while advancing innovation across oncology, rare disease, and emerging therapeutic modalities.

What You'll Do

• Lead pharmacovigilance risk assessment and management strategies for assigned product portfolio
• Oversee adverse event reporting, signal detection, and regulatory submissions
• Manage cross-functional safety committees and coordinate with clinical, regulatory, and medical teams
• Ensure compliance with FDA, ICH, and international pharmacovigilance regulations
• Develop and implement risk minimization strategies aligned with regulatory expectations
• Build and mentor a high-performing pharmacovigilance team

What We're Looking For

• Advanced degree in life sciences, pharmacy, nursing, medicine, or related field
• Extensive pharmacovigilance or drug safety experience in a pharma or biotech setting
• Proven leadership experience managing teams in regulated environments
• Deep knowledge of FDA regulations, ICH guidelines, and adverse event reporting requirements
• Strong analytical and communication skills with meticulous attention to regulatory detail
• Experience in oncology, rare disease, or cell & gene therapy a plus

About Sumitomo Pharma

Sumitomo Pharma is a global biopharmaceutical innovator committed to addressing critical patient needs. With operations across the U.S., our company brings together expertise in oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS to accelerate discovery and deliver transformative treatments to patients worldwide.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.