Pharmaceutical Pharmacovigilance and Drug Safety Audit Checklist

A comprehensive checklist for auditing pharmacovigilance and drug safety processes in pharmaceutical companies to ensure regulatory compliance, patient safety, and effective risk management.

Pharmaceutical Pharmacovigilance and Drug Safety Audit Checklist
by: audit-now
4.2

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About This Checklist

Pharmacovigilance is critical in ensuring the ongoing safety of pharmaceutical products post-marketing. This Pharmaceutical Pharmacovigilance and Drug Safety Audit Checklist is a vital tool for evaluating the effectiveness and compliance of pharmacovigilance systems and processes. By systematically assessing adverse event reporting, signal detection, risk management plans, periodic safety update reports, and regulatory communications, this checklist helps maintain robust drug safety monitoring and timely response to emerging safety concerns. Regular implementation of this comprehensive audit process can significantly enhance patient safety, improve regulatory compliance, and support the ongoing benefit-risk assessment of pharmaceutical products throughout their lifecycle.

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Industry

Pharmaceuticals

Standard

ICH E2A-E2F, EU GVP, FDA Pharmacovigilance Guidance

Workspaces

Research laboratories

Occupations

Pharmacovigilance Auditor
Drug Safety Specialist
Regulatory Affairs Manager
Medical Safety Officer
Quality Assurance Manager

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