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.

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Manager, Compliance Training & Strategic Alliance (CTSA), Pharmacovigilance & Risk Management (PVRM). The Manager reports to the Senior Director, CTSA, PVRM.

The Manager is responsible for providing operational oversight of clinical trial safety activities and supporting post-marketing pharmacovigilance operations across Sumitomo Pharma's development and commercial product portfolio. The role serves as a key partner to Clinical Operations, Clinical Development, Medical Monitoring, Safety Science, Regulatory Affairs, Quality, and external vendors to ensure compliant collection, assessment, processing, reporting, reconciliation, and oversight of safety information throughout the product lifecycle.

The Manager is responsible for study-level safety oversight, management of CROs and pharmacovigilance vendors, compliance monitoring, inspection readiness, and execution of risk-based quality management practices. This role supports both investigational and post-marketing safety activities, drives continuous improvement initiatives, and contributes to maintaining a robust global pharmacovigilance system.

Key Responsibilities:

• Serves as the operational lead for clinical trial safety activities across assigned development programs.

• Provides study-level safety oversight throughout the clinical trial lifecycle, including study startup, conduct, database lock, and study closeout.

• Partners with Clinical Operations, Clinical Development, Medical Monitoring, Safety Science, Regulatory Affairs, and Quality to ensure compliant execution of safety activities.

• Supports identification, escalation, and mitigation of operational safety risks impacting clinical programs.

• Participates in study teams and governance forums, providing expertise on safety operations and regulatory requirements.

• Supports study-level safety governance, inspection readiness, and operational planning activities.

• Manages CROs, pharmacovigilance vendors, and external partners to ensure compliance with contractual obligations, quality agreements, and applicable regulations.

• Monitors vendor performance related to case processing, SAE management, regulatory reporting, reconciliation activities, and compliance requirements.

• Supports both clinical trial and post-marketing safety operations, ensuring quality, timeliness, and inspection readiness.

• Leads investigations, issue resolution, and remediation activities related to vendor performance or compliance concerns.

• Supports governance meetings and performance reviews with internal and external stakeholders.

• Oversees safety data reconciliation activities across clinical systems, safety databases, vendors, business partners, and licensing partners to ensure complete and accurate safety information.

• Develops, monitors, and analyzes clinical trial and post-marketing safety KPIs and KRIs to proactively identify operational risks and compliance trends.

• Performs trend analysis, identifies emerging risks, and implements mitigation plans to support proactive compliance management.

• Ensures adherence to company procedures and global pharmacovigilance regulations throughout the product lifecycle.

• Supports inspection readiness activities for clinical development and post-marketing programs.

• Participates in internal audits, external audits, regulatory inspections, and health authority inquiries.

• Collaborates with Quality and cross-functional stakeholders on CAPAs, root cause investigations, effectiveness checks, and continuous improvement initiatives.

• Maintains inspection-ready processes, documentation, and oversight practices supporting the global pharmacovigilance system.

• Contributes to the development and maintenance of SOPs, work instructions, and operational guidance documents related to clinical trial safety and pharmacovigilance operations.

• Supports implementation of new technologies, process improvements, and organizational initiatives that enhance quality, compliance, efficiency, and inspection readiness.

• Provides subject matter expertise for strategic projects, vendor transitions, system enhancements, and cross-functional initiatives.

• Supports training, onboarding, and knowledge-sharing activities for internal staff and external partners.

Key

Core Competencies:

• Ability to work independently and manage multiple priorities in a dynamic, matrixed environment.

• Strong leadership, influencing, stakeholder…