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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.

Governance provides the framework through which pharmacovigilance risks, decisions and compliance activities are managed.

Why Governance Matters

Effective governance supports accountability, escalation, decision-making and compliance oversight.

Typical Governance Components

Last reviewed: June 2026

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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.

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.

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.

Inspection Readiness

Describes continuous inspection readiness for pharmacovigilance: QPPV oversight, governance, documentation (PSMF, SOPs), vendor oversight, training, validated systems, and common inspection focus areas. Practical activities include audits, mock inspections, PSMF reviews, vendor oversight and CAPA follow-up.

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.

Last reviewed: 2026-06-07