Associate Director, GPV Compliance & Business Management

The Compliance & Business Management (CBM) team supports key Pharmacovigilance (PV) operational, compliance, and business activities across the organization. This role ensures PV compliance, supports contract management, facilitates audit and inspection readiness, manages CAPA and deviation processes, and contributes to metrics reporting, alliance management, training, SOP governance, and documentation quality.

Responsibilities within the CBM team are interchangeable and may shift based on business needs or direction from leadership.

The Associate Director, GPV Compliance & Business Management, supports the development, implementation, and continuous improvement of GPV compliance systems to ensure alignment with global regulatory requirements and internal quality standards. This role leads assigned CBM areas and may coordinate operational activities of vendor partners tomaintainstrong compliance processes.

Key responsibilities include:

• Operational Leadership:
  Lead assigned CBM functional areas and contribute to broader compliance strategy development in collaboration with Global Quality and internal GPV stakeholders.
• Cross-Functional Collaboration:
  
  Work proactively with affiliates, other Otsuka companies, and internal partners to ensure aligned and compliant practices.
• Internal Coordination:
  Partner with CBM leads to ensure consistent execution across sub-functions.
• Vendor Oversight:
  Provide oversight of vendor activities within assigned domains.

This role may be responsible for managing direct reports.

GPV Due Diligence and Alliance Management

• Supports the lifecycle relationship with collaborating companies through PV due diligence activities, development and maintenance of Pharmacovigilance Agreements (PVAs), and ongoing compliance oversight.

• Works cross‑functionally across GPV and with internal Otsuka stakeholders to build alignment, promote mutual understanding, and ensure GPVAM processes are integrated appropriately within Global Pharmacovigilance.

• Partners with GPV and cross‑functional leaders to contribute to strategies that support effective and compliant alliance management.

• Contributes to the harmonization and integration of affiliate companies into GPV processes across functions and regions.

• Manages day‑to‑day GPV alliance activities across Otsuka companies and partners, including preparation, coordination, and facilitation of Pharmacovigilance Committee (PVC) meetings.

• Develops and applies best practices to enhance efficiency and consistency in partner relationship management processes.

• Ensures adherence to global, local, and regional PV requirements and internal policies/procedures, and supports corrective and preventive actions related to PVAs when needed.

• Identifies opportunities to support globalization of GPV processes across functional areas, regions, and affiliates through enhanced collaboration and alignment.

• Facilitates cross‑functional and partner‑related issue resolution by coordinating discussions, clarifying responsibilities, and ensuring timely follow‑through.

• Oversees assigned team members to support compliance with applicable PV requirements, internal standards, and organizational processes.

• Provides guidance, training, and support to direct reports and GPV colleagues on integration and alliance‑related activities.

• Serves as a point of contact for GPVAM for assigned alliances during audits and regulatory inspections, supporting evidence gathering and responses.

• Leads the PV component of CBM due diligence processes for assigned BD projects, focusing on assessment of the target company’s PV capabilities.

• Submits questions through Letters of Query (LoQ), reviews responses, and assesses implications for PV processes and compliance.

• Reviews relevant materials in data rooms and shared repositories to evaluate PV systems, organizational structure, and potential risks.

• Identifies and synthesizes key risks, organizational gaps, and challenges and escalates them to PV leadership as appropriate.

• Contributes to the preparation of structured due diligence reports, ensuring findings are well documented, clearly articulated, and aligned with PV leadership expectations.

• Supports…