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. 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 Manager, GPV Compliance & Business Management, is responsible for executing and coordinating key operational components of the GPV compliance framework. This role ensures timely, accurate delivery of assigned CBM workstream responsibilities.

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

KEY RESPONSIBILITIES

Contract Compliance Management (CCM)

• 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.

Additional activities:

• 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 the 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.

JOB SCOPE (key facts & figures)

• 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 

QUALIFICATIONS/ EXPERIENCE REQUIRED

• 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 proficient- Essential

COMPETENCIES REQUIRED

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.   
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.   
• Patient & Customer Centricity - Maintain an ongoing 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 to enhance work toward common goals.   
• Empowered Development - Play an active role in professional development as a business imperative.  

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing 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 to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $121,103.00 - Maximum $181,125.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Company benefits:  Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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