Pharmaceutical Pharmacovigilance System Audit Checklist

A comprehensive checklist for auditing pharmaceutical pharmacovigilance systems to ensure compliance with global regulations, enhance drug safety monitoring, and support effective risk management practices.

Pharmaceutical Pharmacovigilance System Audit Checklist
by: audit-now
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About This Checklist

Pharmacovigilance is a critical function in the pharmaceutical industry, ensuring the ongoing safety monitoring of medicinal products throughout their lifecycle. This Pharmaceutical Pharmacovigilance System Audit Checklist is designed to comprehensively evaluate the processes, systems, and practices involved in detecting, assessing, understanding, and preventing adverse effects of drugs. By assessing factors such as adverse event reporting, signal detection, risk management, and regulatory compliance, this checklist helps pharmaceutical companies maintain robust pharmacovigilance systems. Implementing this audit process can significantly enhance patient safety, ensure regulatory compliance, and support continuous improvement in drug safety monitoring practices.

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Industry

Pharmaceuticals

Standard

ICH E2A-E2F, EU GVP Modules, FDA Guidance on Good Pharmacovigilance Practices

Workspaces

Pharmaceutical safety departments and pharmacovigilance centers

Occupations

Pharmacovigilance Officer
Drug Safety Physician
Pharmacovigilance Auditor
Regulatory Affairs Specialist
Medical Information Manager

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