Senior Manager, PVRM Safety Scientist

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.

Sumitomo Pharma America is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait;

genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at reasonableaccomod This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

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…