Governance & Oversight
Explore all topics, guides, and frameworks related to Governance & Oversight.
Articles in this section
6- 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 →
- 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 →
- 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 →
- 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 →
- Global vs EU PSMF A practical guide to understanding global, EU and hybrid PSMF models in multinational pharmacovigilance systems. 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 →