Associate Director, GPV Compliance & Business Management
About the role
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
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.
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.
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.
Attends Global / Regional meetings as required.
Presents compliance metrics at Global Meetings.
Supports presentation of PV due diligence outcomes and recommendations to the Business Development (BD) team and other stakeholders.
Qualifications/Experience
Bachelor's degree- required
Experience working in a global setting
Experience in managing vendor relationships and oversight
Minimum 4 years PV Compliance or Quality Management experience in the pharmaceutical industry or relevant leadership experience
Microsoft proficient
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
Competencies
Accountability for Results
Strategic Thinking & Problem Solving
Patient & Customer Centricity
Impactful Communication
Influence at all levels to achieve the best results for Otsuka
Respectful Collaboration
Empowered Development
Pay
$150,034.00 - $224,250.00, plus incentive opportunity
Schedule
TBD