Manager, PVRM

🕒 May 8

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Logo of Sumitomo Pharma America, Inc.

Sumitomo Pharma America, Inc.

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Sumitomo Pharma America, Inc. is dedicated to improving the health and well-being of people around the world by driving innovative treatments, science, and technology. The company focuses on addressing patient needs in critical areas such as psychiatry & neurology, oncology, urology, women's health, rare diseases, and cell & gene therapy. As a subsidiary of Sumitomo Pharma Co. , Ltd. , SMPA embodies the promise of combining technology and life-sciences expertise to improve patient outcomes. With a diverse pipeline of preclinical and clinical programs, SMPA is committed to delivering patient-first solutions through a technology-driven approach.

📋 Description

• Provide pharmacovigilance and risk management support for assigned products across their lifecycle • Manage the benefit‑risk profile of products, ensure patient safety, and support regulatory compliance • Contribute to signal detection, aggregate safety reporting, safety governance forums, and inspection readiness activities • Serve as a subject matter expert within the assigned program(s)

🎯 Requirements

• Minimum of bachelor’s level degree in a health care/life science related field • Master’s or other graduate degree preferred • Minimum 4 years experience within Pharmacovigilance and in the pharmaceutical industry • Prior experience in oncology, and/or neurology is strongly preferred • Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and marketed products

🏖️ Benefits

• merit-based salary increases • short incentive plan participation • eligibility for our 401(k) plan • medical, dental, vision, life and disability insurances • flexible paid time off • 11 paid holidays plus additional time off for a shut-down period during the last week of December • 80 hours of paid sick time upon hire and each year thereafter

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