Pharmacovigilance
(EU GVP)
OZQA PRODUCTS
The document templates in this section are designed to support companies in building and maintaining a compliant pharmacovigilance system, particularly in preparation for EU Marketing Authorisation Applications (MAA) and ongoing post-authorisation activities.
Ready-to-use documents developed according to GxP standards
Pharmacovigilance is a critical regulatory function ensuring the continuous monitoring of the safety and benefit-risk profile of medicinal products throughout their lifecycle.
Pharmaceutical and biotechnology companies operating in the European Union must establish and maintain a pharmacovigilance system compliant with EU Good Pharmacovigilance Practice (GVP) and requirements from the European Medicines Agency (EMA).
A structure built to withstand inspection
These templates are especially relevant for companies operating with lean or outsourced pharmacovigilance models, where oversight, governance, and clear documentation are essential to ensure compliance.
A SOP system that grows with you
The templates provide structured frameworks for key pharmacovigilance elements, including:
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Pharmacovigilance System Master File (PSMF)
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Summary of the Pharmacovigilance System (SPS)
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EU-QPPV roles, responsibilities, and governance
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PV system procedures and oversight
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Safety data collection and reporting processes
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Compliance monitoring and performance tracking
All templates are provided in editable formats and can be adapted to fit the organization’s pharmacovigilance model, whether activities are handled internally, by consultants, or through external PV vendors.