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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 https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

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.

Job Overview

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.

Job Duties and Responsibilities

+ 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 documents, including Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and expectedness guides, as applicable.

+ Work collaboratively with PVRM and cross-functional team members to manage the benefit-risk profile of assigned products and support patient safety.

+ Review literature search strategies and literature monitoring activities, with vendor support, and ensure relevant information is incorporated into signal detection and evaluation activities.

+ Participate in and lead assigned aggregate safety report activities, including data compilation, analysis, interpretation, and preparation or review of assigned sections, with vendor support as applicable.

+ Coordinate responses to ad hoc safety issues and requests from regulatory authorities, study sites, healthcare professionals, and other stakeholders in collaboration with appropriate medical and cross-functional colleagues.

+ Serve as a PVRM subject matter expert for assigned programs and contribute expertise across R&D and Commercial functions.

+ Develop or contribute to Standard Operating Procedures (SOPs), Work Instructions, and other controlled PVRM documents, as assigned.

+ Contribute to departmental and cross-functional inspection readiness, quality, compliance, and operational improvement initiatives.

+ Support PVRM and cross-functional projects requiring safety input, promote compliance with applicable regulatory requirements and internal procedures, and foster a Patient First culture consistent with SMPA values.

Key Core Competencies

+ Strong understanding of pharmacovigilance, drug safety, benefit-risk assessment, and global safety requirements.

+ Demonstrated experience with signal detection, evaluation, and safety data analysis.

+ Experience preparing and/or contributing to aggregate safety reports, regulatory submissions, and responses to regulatory authorities, including FDA and EMA and/or other global health authorities.

+ Ability to interpret clinical and safety data and communicate safety findings clearly to cross-functional stakeholders.

+ Demonstrated ability to operate effectively in a cross-functional and matrixed environment.

+ Strong collaboration and relationship-building skills across organizational and geographic boundaries.

+ Excellent written and verbal communication skills.

+ Demonstrated ability to work independently, manage multiple priorities, and deliver high-quality work with minimal supervision.

+ Demonstrated leadership and project-management capabilities.

Education and Experience

+ Minimum of a bachelor's degree in a healthcare, life science, or related scientific field; advanced degree preferred.

+ Minimum 6 years of relevant pharmacovigilance, drug safety, or related pharmaceutical/biotechnology industry experience.

+ Relevant experience in clinical development safety, signal management, aggregate reporting, and/or benefit-risk assessment preferred.

+ Prior experience leading cross-functional activities, programs, or projects strongly preferred.

+ Prior experience in oncology and/or neurology preferred.

+ Comprehensive understanding of applicable FDA and EU pharmacovigilance requirements and GCP/GVP/ICH safety guidelines for investigati...

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