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Post : Senior Manager QPPV Office
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.
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Candidate Profile
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.
Additional Information
Experience : 4+ years
Qualification : Bachelor's degree in life sciences, pharmacy
Location : New Delhi, India
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 20th November 2026
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