Senior Manager QPPV Office

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.

Responsibilities

Functional lead for the management and governance of Pharmacovigilance Agreements (PVAs) across a diverse portfolio of clients, partnerships, and pharmacovigilance systems; End-to-end lifecycle management of PVAs, including planning, authoring, review, negotiation support, implementation, maintenance, reconciliation, and periodic review; Drafting and updating agreements, coordinating stakeholder reviews, tracking implementation activities, managing agreement repositories, and ensuring timely execution of contractual updates; Acting as primary subject matter expert for PVA-related activities and guiding the allocation of pharmacovigilance responsibilities between business partners; Ensuring consistency across PVAs, Quality Agreements, contractual documentation, PSMFs, procedural documents, and operational practices; Supporting client-facing discussions, due diligence, business development, partnership transitions, and regulatory inspections; 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 identifying contractual compliance risks, resolving gaps and ambiguities, supporting CAPA implementation, and contributing to inspection readiness; Supporting broader QPPVO governance activities, including PSMF management, audit readiness, compliance monitoring, quality management, procedural development, governance reporting, and onboarding and training programs

Requirements

Bachelor's degree in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related field, or equivalent experience required; 4+ years of experience in pharmacovigilance, drug safety, epidemiology, risk management, scientific consulting, regulatory affairs, or a related field required

Nice to have

Certification in pharmacovigilance, drug safety; Certification in regulatory affairs, clinical safety; Certification in quality management, auditing