Senior Manager, CTSA, PVRM

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.

The Senior Manager is a strategic leader responsible for overseeing Pharmacovigilance (PVRM) and non-PVRM vendor management, adverse event handling and reporting, and supporting global PV systems. This role oversees compliance training, quality monitoring, audit and inspection preparedness, and cross-functional initiatives to ensure operational excellence and regulatory adherence. The Senior Manager works closely with the PVRM Information Management (IM) and Safety Science groups and is a member of a cross-functional working team as part of a matrix team supporting PV activities.

• Lead strategic relationships with PVRM and non-PVRM vendors, ensuring contract compliance, quality performance, and alignment with business objectives.
• Provide strategic oversight of adverse event (AE) management and reporting processes, ensuring compliance with global regulatory requirements.
• Conduct routine AE case quality checks, support special projects, and collaborate within PVRM and Quality on root cause analysis, corrective and preventive actions, effectiveness checks, and process improvements.
• Lead audit and inspection preparedness, participate in cross-functional teams, and support regulatory inspections and internal audits.
• Develop and maintain PV staff learning plans, manage compliance activities, and serve as the primary liaison for organized data collection and reconciliation of safety information.
• Oversee the development, maintenance, and continuous improvement of standard operating procedures (SOPs) across PV operations and quality systems to ensure consistency, regulatory compliance, and operational excellence.
• Support global safety planning and coordination, and maintain relationships with business partners, affiliates, and subsidiaries.
• Provide expert support for Pharmacovigilance Agreements (PVAs), including but not limited to drafting, reviewing, and maintaining PVAs with internal and external partners. Support Alliance Management to ensure PVAs are compliant with global regulatory requirements and support the implementation and oversight of PVA obligations across the organization.
• Contribute to standard operating procedures relevant to pharmacovigilance.
• Mentor and coach team members, foster a high-performance culture, and deliver results in a dynamic, fast-paced environment.
• Assist with other department activities as needed.

• Works effectively with minimal supervision.
• High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture.
• Self-motivated with solid management skills, and the ability to lead or participate effectively in cross-functional teams.
• Skilled mentoring and coaching to develop team deliverables.
• Proficient verbal and written communication skills.
• Proficient in MS Office applications and adaptable to technology and systems.
• Knowledge of current US and international pharmacovigilance regulations.
• Ability to multi-task under limited direction and on own initiative.
• Excellent interpersonal, written and verbal communication skills.
• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
• Must have excellent customer-service orientation, high degree of professionalism, and ability to work with independently.
• Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.

• Bachelor's degree required.…