POSITION SUMMARYThe 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 activitiesKEY RESPONSIBILITIESContract 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 requiredPresent compliance metrics at Global MeetingsContribute 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 officesMay perform any other duties as needed.JOB SCOPE (key facts & figures)Travel as applicable Knowledge of ICH, US & EU regulations and requirements for pharmacovigilanceSolid 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 REQUIREDBachelor's degree- required Experience working in a global settingExperience in managing vendor relationships and oversightMinimum 2 years PV Compliance or Quality Management experience in the pharmaceutical industry or relevant leadership experienceMicrosoft proficient- EssentialCOMPETENCIES REQUIREDAccountability 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. CompetenciesAccountability 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.Application Deadline: This will be posted for a minimum of 5 business days.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.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. 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 gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request. Statement Regarding Job Recruiting Fraud ScamsAt Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
