QPPV, Governance & PSMF
Explore all topics, guides, and frameworks related to QPPV, Governance & PSMF.
Articles in this section
23- Pharmacovigilance Governance Overview of pharmacovigilance governance covering accountability, escalation, decision-making and oversight. Describes safety governance committees, escalation procedures, compliance reporting, risk review and management oversight to support regulatory compliance. Read Article →
- How to Become a QPPV Explains how aspiring QPPVs can build pharmacovigilance experience (case processing, aggregate reporting, signal management), develop oversight and inspection skills, and cultivate leadership competencies such as decision-making, risk assessment, communication and stakeholder management. Read Article →
- What is a Local Safety Officer? Explains the role of Local Safety Officers (LSOs), their typical responsibilities (local adverse event management, regulatory interactions, literature, training, inspections), relationship with the QPPV, and inspection considerations. Read Article →
- QPPV Responsibilities Describes the QPPV role as a governance and oversight function responsible for ensuring the pharmacovigilance system operates effectively and remains compliant. Covers PSMF awareness, inspection readiness, product safety monitoring, vendor oversight, escalation, governance forums and regulatory interactions. Read Article →
- UK QPPV Requirements Summarizes responsibilities and expectations for UK Qualified Persons Responsible for Pharmacovigilance: when a UK QPPV is required, oversight duties, availability and deputy arrangements, MHRA inspection involvement, and relationship with the PSMF. Read Article →
- QPPV Interview Questions A curated list of common QPPV interview questions covering responsibilities, oversight of global PV systems, compliance monitoring, inspections, PSMF, signal and risk management, vendor oversight, CAPA and leadership topics to assess decision-making and communication. Read Article →
- Deputy QPPV Overview of the Deputy QPPV role: purpose, common responsibilities and expectations. Covers continuity arrangements, governance participation, inspection support and maintaining PV system awareness to ensure oversight when the QPPV is unavailable. Read Article →
- How to Become a QPPV Describes common professional backgrounds, essential experience areas (safety operations, compliance, regulatory oversight), a typical development pathway and practical advice for transitioning into QPPV responsibilities. Read Article →
- What is a Safety Data Exchange Agreement (SDEA)? A comprehensive guide to Safety Data Exchange Agreements, responsibilities, reporting obligations, vendor oversight and inspection readiness. Read Article →
- What Is a QPPV? Role, Legal Position and Pharmacovigilance Oversight The qualified person responsible for pharmacovigilance is the continuously available individual through whom an EU marketing authorisation holder maintains expert oversight of its pharmacovigilance system and medicinal-product safety profiles. This article explains the role from first principles, distinguishes QPPV oversight from operational work and corporate accountability, and shows how authority, information, decisions and evidence connect. Read Article →
- What is a Pharmacovigilance System Master File (PSMF)? A comprehensive guide to understanding the PSMF as the blueprint, governance framework and operational model of a pharmacovigilance system. Read Article →
- Selecting and Appointing a QPPV: In-House, External and Hybrid Models How to select and appoint a QPPV and determine whether an in-house, external or hybrid model provides the authority, access, capacity and continuity needed for effective pharmacovigilance oversight. Read Article →
- QPPV Metrics Defines key metrics QPPVs use to monitor pharmacovigilance systems — case processing, compliance, vendor oversight and governance metrics. Explains how metrics inform oversight, highlight trends and support inspections without replacing professional judgement. Read Article →
- PSMF Inspection Readiness Checklist A comprehensive self-assessment framework for maintaining an inspection-ready Pharmacovigilance System Master File. Read Article →
- PSMF and QPPV Oversight An advanced guide to using the PSMF as a governance, oversight and risk management tool. Read Article →
- PSMF Maintenance and Change Control A practical guide to PSMF maintenance, governance, review cycles, change management and long-term sustainability. Read Article →
- PSMF Metrics and KPIs A practical guide to PSMF metrics, governance indicators and inspection readiness measurement. Read Article →
- PSMF Oversight Defines the Pharmacovigilance System Master File (PSMF), explains the QPPV's oversight responsibilities and relationship to the PSMF, outlines common oversight areas (organisation, QPPV arrangements, vendors, systems, quality and business continuity) and gives practical advice on maintaining an accurate, inspection‑ready PSMF through periodic review and cross‑functional collaboration. Read Article →
- PSMF Annexes Guide A practical guide to understanding, maintaining and governing PSMF annexes within a pharmacovigilance system. Read Article →
- Common PSMF Inspection Findings A practical inspection-focused guide to understanding recurring PSMF deficiencies and how to prevent them. Read Article →
- How Often Should a PSMF be Reviewed? Regulations don't mandate a fixed PSMF review interval. Organisations should update the PSMF promptly after significant changes (QPPV appointment, deputy changes, vendors, safety database updates, restructures, inspection findings) and may perform formal periodic reviews (quarterly, semi‑annual or annual). Inspectors expect the PSMF to reflect actual practice; treat it as a continuously maintained living document. Read Article →
- Global vs EU PSMF A practical guide to understanding global, EU and hybrid PSMF models in multinational pharmacovigilance systems. Read Article →
- EU QPPV Requirements: Qualification, Location, Authority and Availability EU QPPV compliance is more than naming an individual. The marketing authorisation holder must establish an appropriately qualified, continuously available role that resides and operates in the Union, has adequate knowledge and support, can access the pharmacovigilance system and PSMF, and is positioned to exercise real authority. Read Article →