Manager, PVRM

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August 1

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Sumitomo Pharma America, Inc.

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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.

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Work collaboratively with PV and cross-functional team members to manage the benefit/risk profile of assigned products and ensure patient safety. • Assist in signal detection activities including data assembly, signal validation, and signal evaluation. • Perform literature monitoring (with vendor support) and ensure appropriate sources are incorporated into signal detection activities. • Participate and lead aggregate safety report activities including data compilation and analysis as well as writing of assigned sections (with vendor support.) • Compile agenda, data, slides, and minutes in collaboration with Program Safety Lead for cross-functional Safety Management Team meetings. • Represent PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional program and project teams, as required. • Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician, including communication with internal and cross-functional team members, submission of data requests, and compilation of analysis and results. • Contribute to internal departmental and/or cross-functional inspection readiness and operational improvement activities. • Collaborate with Clinical Development to interpret safety data from ongoing clinical trials. • Serve as a subject matter expert in Pharmacovigilance, including operations and medical, within the assigned program. • Support collaboration with external partners

🎯 Requirements

• Minimum of bachelor’s level degree in a health care/life science related field, with Master’s or other graduate degree preferred. • Minimum 3 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 • 401(k) plan eligibility • Medical, dental, vision, life and disability insurances • Flexible paid time off • 11 paid holidays • Additional time off for a shut-down • 80 hours of paid sick time