Senior Manager, PVRM Safety Scientist

US-Remote

Full time

R01595

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.

For more information on SMPA, visit our website  or follow us on Linked In.

Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women’s health, rare disease, and cell & gene therapies. The company’s diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma’s 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner.

SMPA is a Sumitomo Pharma company.

The Senior Manager, Pharmacovigilance Scientist serves as a primary Pharmacovigilance and Risk Management (PVRM) point of contact for assigned programs and works collaboratively with cross-functional colleagues, global development teams, and strategic partners. This role leads and supports safety evaluation and risk management activities and ensures appropriate application of safety governance processes for assigned compounds and products.

• Lead cross-functional Safety Management Team (SMT) meetings and provide safety guidance and input to key documents, including Investigator Brochures (IBs), informed consent forms (ICFs), protocols, study reports, regulatory reports, and regulatory responses.
• Contribute to signal detection, monitoring, evaluation, interpretation, escalation, and communication of safety information through established safety governance processes.
• Maintain ongoing monitoring and assessment of safety profiles for assigned investigational and marketed products, supporting continuous benefit-risk evaluation.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other functions. Represent PVRM on cross-functional teams and at partner safety meetings, including Joint Safety Forums (JSFs) and Pharmacovigilance Committee (PVC) meetings, as applicable.
• Review adverse event reports, including serious cases, to support appropriate interpretation, consistency, and quality across individual case and aggregate safety assessments; support Analysis of Similar Events as needed.
• Review relevant clinical coding, including reactions, suspect/concomitant products, indications, laboratory data, and medical history, and support preparation and review of Investigator Brochures, protocols, informed consent documents, clinical study reports, and other safety-related documents.
• Facilitate early identification and escalation of safety issues through established safety governance processes. Serve as SMT Chair or Quorum member as assigned.
• Serve as a PVRM subject matter expert in the review of study protocols, interim clinical trial reports, clinical study reports, safety summary documents, and responses to regulatory requests.
• Support preparation and presentation of individual case safety issues; conduct aggregate safety data analyses and interpretation; contribute to submission documents, including ISS and SCS, and support development of risk-mitigation strategies.
• Contribute to the development and maintenance of safety and risk-management…