Manager, GPV Compliance & Business Management

Position Summary

The Compliance & Business Management (CBM) team supports key Pharmacovigilance (PV) operational, compliance, and business activities across the organization. The Manager, GPV Compliance & Business Management, is responsible for executing and coordinating key components of the GPV compliance framework, ensuring timely and accurate delivery of assigned CBM workstream responsibilities.

• Functional Execution:
  Independently manage assigned CBM activities.
• Cross‑Functional Support:
  Collaborate with internal GPV teams, affiliates, and partner functions.
• Documentation & Coordination:
  Support preparation, tracking, and reporting of compliance deliverables.
• Vendor Interaction:
  Act as the point of contact for assigned vendor activities.

• Review global contracts for safety‑relatedness and ensure accurate and timely entry into the OCT system.
• Maintain safety‑relatedness commodity code mapping in US Ariba and support updates as needed.
• Collaborate with Finance, Procurement, and Vendor Management on cross‑functional activities related to PV contract processes.
• Monitor and report CCM performance metrics associated with the OCT system and contract assessment process.
• Support the global PV vendor qualification process, including maintaining relevant procedural documents (e.g., CO‑7002‑WP‑004).
• Maintain the global qualified PV vendor list and ensure accuracy of supporting documentation.
• Provide day‑to‑day oversight of the OCT system and maintain system‑related procedural documents (e.g., CO‑7005 GSOP cluster, OCT maintenance procedure, user manual, decision grid).
• Serve as data responsible for PSMF Annex B3, ensuring routine updates and accuracy.
• Support audits and inspections related to global PV contracts by preparing documentation and responding to requests.
• Contribute to continuous improvement initiatives, including process enhancements and technology enablement activities (e.g., supporting AI tool development and implementation).
• Maintain global PV clause template language and guidance, and coordinate with Legal on region‑specific Master Service Agreement templates.
• Act as a GPV subject matter resource for external service provider contracts and related inquiries, ensuring consistent application of contractual PV terms.
• Attend Global / Regional meetings as required.
• Present compliance metrics at Global Meetings.
• Contribute to maintenance of PV System Master File as required.
• May be assigned to lead or assist with special projects or process development.
• Collaborate with Regional PV offices for process improvement initiatives and corrective and preventive actions identified by the Regional PV offices.
• May perform any other duties as needed.

• Travel as applicable.
• Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance.
• Solid background and experience in pharmaceutical quality system management (GxP).
• Experience with coordination and/or participation in PV audits in the pharmaceutical industry.
• Strong project management, interpersonal, communication and presentation skills.
• Ability to accomplish objectives through influence in a matrix organization.
• Strong computer skills with Word, Excel, PowerPoint, and Outlook.

• Bachelor’s degree required.
• Experience working in a global setting.
• Experience in managing vendor relationships and oversight.
• Minimum 2 years PV Compliance or Quality Management experience in the pharmaceutical industry or relevant leadership experience.
• Microsoft proficiency – essential.

• Accountability for Results – stay focused on key strategic objectives, maintain high standards of performance, and lead change.
• Strategic Thinking & Problem Solving – make decisions considering long‑term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity – maintain focus on the needs of our customers and/or key stakeholders.
• Impactful Communication – communicate with logic, clarity, and respect.
• Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration – seek and value others’ perspectives and strive for diverse partnerships.
• Empowered…