Senior Manager, CTSA, PVRM

Sumitomo Pharma • Marlborough, MA

2d

About The Position

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. 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.

Requirements

• 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. Preferably in a scientific, regulatory, or health-related field; advanced degree preferred.
• Minimum 8 – 10 years of relevant experience in healthcare industry.
• Minimum 5 years of experience specific to Pharmacovigilance operations and compliance.
• Project leadership/management skills.
• Excellent understanding of U.S. regulations and guidances, and a strong working knowledge of global regulations and guidances, e.g., European Economic Area, United Kingdom, and Canadian regulatory frameworks.

Responsibilities

• 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.

Benefits

• opportunity for merit-based salary increases
• short incentive plan participation
• eligibility for our 401(k) plan
• medical, dental, vision, life and disability insurances and leaves provided in line with your work state
• flexible paid time off
• 11 paid holidays plus additional time off for a shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 51-100 employees