Why Are Pharmacovigilance Audits Essential?

Pharmacovigilance (PV) audits are a regulatory requirement under EU GVP Module IV. They serve to verify that the pharmacovigilance system of a Marketing Authorisation Holder (MAH) is compliant, effective, and aligned with global and local obligations. These audits evaluate the adequacy of PV processes, the reliability of safety data management, and the implementation of oversight mechanisms across the PV system.

Audits must be planned based on risk, conducted independently, and thoroughly documented. EU GVP Module IV does not mandate ISO standards, but its requirements for PV audits are closely aligned with the general auditing principles set out in ISO 19011.

Well-executed audits help identify compliance risks before they escalate into inspection findings. In a regulatory environment where authorities expect proactive quality oversight, audits are more than a regulatory requirement - they are a cornerstone of system oversight and long-term compliance.

Pharmacovigilance Audits

Hands-on PV audits – flexible, independent, and risk-based.

Audit Targets in Pharmacovigilance Systems

To ensure compliance across the entire pharmacovigilance system, audits are conducted at various enteties:

Many companies face challenges such as limited internal resources, lack of independence, or complexity in managing audits across global networks. An external auditor can provide the objectivity, expertise, and capacity required to ensure audit quality and regulatory alignment.

Partner Audits

Auditing distributors, licensing partners, or service providers performing PV activities under contractual agreements. These audits ensure outsourced responsibilities are fulfilled and oversight is maintained.

Internal Audits (Self-Inspections)

Independent assessments of the company's own PV system to proactively detect compliance risks, validate the effectiveness of processes, and prepare for authority inspections.

Affiliate Audits

Evaluating local PV activities operated by affiliates or subsidiaries, including national QPPVs or Local Contact Person for PV. The goal is to ensure alignment with corporate standards and national regulations.

Audits of Critical PV Processes

Auditing defined critical processes such as ICSR management, signal detection, literature screening, or PSMF maintenance - to ensure functionality, compliance, and data integrity.

Audit Planning & Coordination

Definition of audit scope, timeline planning, stakeholder communication, and provision of questionnaires and agendas.

Audit Execution

On-site or remote audits conducted independently to assess processes, detect issues, and ensure objective evaluations.

Audit Reporting

Preparation of clear, regulator-ready audit reports with traceable documentation and clearly classified findings.

My Services

End-to-End Support for PV Audits

CAPA Planning & Implementation Support

Development of sustainable CAPAs that meet regulatory expectations and monitoring CAPA implementation.

Audit Documentation Toolkit

Provision and/or customization of essential templates: questionnaires, audit agendas, reporting formats, and inspection-ready audit checklists — aligned with EU GVP and ISO 19011 principles.

Support When You Are Being Audited

Strategic and hands-on assistance when your company is audited by a partner, including preparation of documentation, mock interviews, and post-audit response support.

I support you throughout the entire audit cycle — from planning and execution to documentation and CAPA follow-up.

✔ Stronger Inspection Readiness

Demonstrate a robust PV system by proactively identifying and addressing compliance gaps.

✔ Improved System Oversight

Gain clarity over internal processes, partners, and affiliates through structured and independent audits.

✔ Audit-Proof Documentation

Ensure consistent and well-documented audits that meet EU GVP expectations.

✔ Sustainable CAPA Implementation

Address root causes effectively and implement improvements that stand up to regulatory scrutiny and future inspections.

✔ Objective Expert Assessment

Benefit from independent audit execution - unbiased, experienced, and aligned with current requirements.

Your Benefits – Reliable Audits. Stronger Compliance

hands taking notes representing the close up of a pharmacovigilance audit

Need expert support for your next PV audit?

Whether you need support with a single audit, CAPA management, or the coordination of your entire audit programme - I provide tailored services to strengthen your pharmacovigilance compliance. Contact me to discuss how I can assist you!

Get in Touch