Manager, GPV Compliance & Business Management
About The Position
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.
Requirements
- 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
- 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
Responsibilities
- Independently managing assigned CBM activities
- Collaborate with internal GPV teams, affiliates, and partner functions.
- Support the preparation, tracking, and reporting of compliance deliverables.
- Act as point of contact for assigned vendor activities
- 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.
- 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.
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
- paid leave programs
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
