Senior Manager, Pharmacovigilance Scientist

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview

The Senior Manager, Pharmacovigilance Scientist serves as the primary Pharmacovigilance and Risk Management (PVRM) point of contact for cross-functional, global development, and strategic partnerships. This role leads evaluation and risk management activities, ensuring adherence to safety governance for assigned compounds and products.

Job Duties and Responsibilities

• Lead cross-functional Safety Management Team (SMT) meetings to assess drug safety policies, 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 updates of safety profiles for assigned investigational and marketed products, ensuring continuous benefit-risk assessment.
• Collaborate with colleagues in Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other departments. Represent PVRM in cross-functional Steering Committee meetings and at partner meetings including Joint Safety Forums (JSFs) and Pharmacovigilance Committee (PVC) meetings.
• Review adverse event reports—including serious cases—ensuring appropriate interpretation, consistency, and quality in both individual case and aggregate safety assessments; assist with Analysis of Similar Events as needed.
• Review clinical coding (e.g., reactions, suspect/concomitant products, indications, laboratory data, medical history) and support preparation of investigator brochures, protocols, informed consent documents, final study reports, and other relevant safety documents.
• Facilitate early identification of safety issues requiring escalation from the SMT to the Therapeutic Area Safety Committees (TASCs) or Executive Safety Committee (ESC). Serve as SMT Chair or Quorum member as assigned.
• Serve as a subject matter expert (SME) in study protocol design, review interim clinical trial reports, clinical study reports, safety summary documents, and responses to regulatory requests.
• Support preparation and presentation of individual case safety report issues; conduct aggregate data analyses and interpretation; develop strategies for submission documents (e.g., ISS, SCS); and propose risk mitigation strategies for internal discussions.
• Contribute to the development and maintenance of internal safety documents, including Risk Management plans (REMS, RMPs) and expectedness guides.
• Work collaboratively with pharmacovigilance and cross-functional team members to manage the benefit-risk profile of assigned products, ensuring patient safety.
• Review literature search strategies and literature monitoring (with vendor support) and ensure appropriate incorporation of sources into signal detection activities.
• Participate in aggregate safety report generation, including data compilation, analysis, and assigned section writing (with vendor support).
• Coordinate responses to ad hoc safety issues raised by regulatory authorities, sites, or healthcare professionals.
• Serve as a subject matter expert in PVRM for assigned programs and contribute expertise across R&D and Commercial functions at SMPA.
• Develop