PharmaLex
Website:
pharmalex.com
Job details:
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Job Details
Job Responsibilities
The Senior Manager, Pharmacovigilance Agreements (PVA) is a key member of the QPPV Office (QPPVO) organization and serves as the functional lead for the management and governance of Pharmacovigilance Agreements (PVAs) across a diverse portfolio of clients, partnerships, and pharmacovigilance systems.
- The role combines strategic oversight with hands-on operational responsibility, ensuring that pharmacovigilance contractual obligations are accurately defined, effectively implemented, and maintained in compliance with applicable regulatory requirements and industry expectations.
- The incumbent is responsible for the end-to-end lifecycle management of PVAs, including agreement planning, authoring, review, negotiation support, implementation, maintenance, reconciliation, and periodic review.
- This includes direct involvement in drafting and updating agreements, coordinating stakeholder reviews, tracking implementation activities, managing agreement repositories, ensuring timely execution of contractual updates, and supporting the translation of contractual obligations into operational pharmacovigilance processes.
- Acting as the primary subject matter expert for PVA-related activities, the Senior Manager provides guidance on the allocation of pharmacovigilance responsibilities between business partners and ensures consistency across PVAs, Quality Agreements, contractual documentation, PSMFs, procedural documents, and operational practices.
- The role supports client-facing discussions, due diligence activities, business development initiatives, partnership transitions, and regulatory inspections by providing expert contractual and compliance oversight.
- Close collaboration with QPPVs, Local Safety Officers, Pharmacovigilance Operations, Medical Information, Regulatory Affairs, Quality Assurance, Legal, Commercial, Business Development, Project Management, and external client stakeholders.
- Proactively identify contractual compliance risks, resolve gaps and ambiguities, support CAPA implementation, and contribute to inspection readiness initiatives.
- As an integral member of the QPPV Office, the role is not limited to PVA management activities. Depending on business priorities, resource requirements, and organizational needs, the Senior Manager may also be required to support broader QPPVO governance activities, including PSMF management and maintenance, inspection and audit readiness, compliance monitoring, quality management initiatives, procedural development, governance reporting, onboarding and training programs, and other operational or strategic projects within the QPPV Office.
- The incumbent is therefore expected to maintain a broad understanding of pharmacovigilance system governance and contribute flexibly to the overall objectives and success of the QPPVO function.
Qualification
Bachelor's degree in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related field, or equivalent experience required.
Experience & Skills
4+ years of experience in pharmacovigilance, drug safety, epidemiology, risk management, scientific consulting, regulatory affairs, or a related field required.
Certification in pharmacovigilance, drug safety preferred. Certification in regulatory affairs, clinical safety preferred. Certification in quality management, auditing preferred.
What Cencora offers
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full time
Affiliated Companies
Affiliated Companies: PharmaLex GmbH
Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
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