Compliance Manager

POSITION SUMMARY The Compliance & Business Management (CBM) team supports key Pharmacovigilance operational, compliance, and business activities across the organization. The Manager, GPV Compliance & Business Management, executes and coordinates key operational components of the GPV compliance framework, ensuring timely, accurate delivery of assigned CBM workstream responsibilities. RESPONSIBILITIES Functional Execution: Independently managing 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 point of contact for assigned vendor activities. KEY RESPONSIBILITIES Contract Compliance Management (CCM) tasks include: Review global contracts for safety-relatedness and ensure timely, accurate entry into the OCT system. Maintain safety-related commodity code mapping in US Ariba and support updates. Collaborate with Finance, Procurement, and Vendor Management on cross‑functional PV contract activities. Monitor and report CCM performance metrics associated with the OCT system and contract assessment process. Support the global PV vendor qualification process and maintain relevant procedural documents. Maintain the global qualified PV vendor list and ensure supporting documentation accuracy. Provide day‑to‑day oversight of the OCT system and maintain system‑related procedural documents. 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, process enhancements, and technology enablement activities (e.g., supporting AI tool development). Maintain global PV clause template language and guidance, coordinating with Legal on region‑specific Master Service Agreement templates. Act as a GPV subject matter resource for external service provider contracts and related inquiries. ADDITIONAL ACTIVITIES Attend Global / Regional meetings as required. Present compliance metrics at Global Meetings. Contribute to maintenance of PV System Master File as required. Lead or assist with special projects or process development. Collaborate with Regional PV offices for process improvement initiatives and corrective and preventive actions. Perform any other duties as needed. JOB SCOPE (Key Facts & Figures) Travel as applicable. Knowledge of ICH, US & EU regulations for pharmacovigilance. Solid background 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. COMPETENCIES REQUIRED Accountability for Results – Stay focused on key strategic objectives, be accountable for 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 an ongoing focus on the needs of our customers and stakeholders. Impactful Communication – Communicate with logic, clarity, and respect, influencing at all levels. Respectful Collaboration – Seek and value others' perspectives, fostering diverse partnerships. Empowered Development – Play an active role in professional development. PAY RANGE Minimum $121,103.00 – Maximum $181,125.00, plus incentive opportunity. This range represents typical starting pay for individuals hired in the United States. 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, generous 401(k) match, flexible time off, paid holidays, and paid leave programs. EEO STATEMENT Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. DISCLAIMER This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. #J-18808-Ljbffr