Quality & Compliance Services in Pharmacovigilance

Why Is PV Integration into the Quality System Essential?

A pharmacovigilance system cannot function in isolation - it must be an integrated part of the company’s overall Quality Management System (QMS).
According to EU GVP Module II, companies must ensure that PV activities are embedded into the wider quality framework, and that cross-functional quality processes effectively support the pharmacovigilance system.

A compliant PV system must maintain oversight not only over core PV activities, but also over quality-driven processes that impact pharmacovigilance compliance and system integrity.
This is critical for protecting patient safety, securing regulatory compliance, and providing full transparency to the Qualified Person for Pharmacovigilance (EU-QPPV).

EU GVP Module II requires that the pharmacovigilance system is fully described within the Pharmacovigilance System Master File (PSMF), including:

• A complete list of standard operating procedures (SOPs) relevant to PV activities.

• Oversight of associated quality processes that impact the pharmacovigilance system, even if managed by other departments.

Relevant cross-functional processes include, for example:

• Complaint and product defect management

• Recall and withdrawal procedures

• Business continuity and disaster recovery planning

• Archiving and documentation processes

• Change control and deviation management

• GxP-compliant training systems

• Regulatory Affairs processes (e.g., safety variation submissions)

• Medical Information handling (e.g., adverse drug reaction capture)

• Clinical trial safety handover procedures

• IT/data integrity management for PV systems

• Vendor oversight and third-party management

• Risk management implementation (e.g., RMP measures)

• PV-relevant contract management (e.g., PVA/DSAs/SDEAs)

In short: Pharmacovigilance quality management requires seamless cross-functional collaboration and clear integration into the company’s QMS.

Regulatory Basis – What Does EU GVP Say?

Mapping of PV-Relevant Quality Interfaces

Identification of all cross-functional processes that impact PV compliance and their documentation in the PSMF.

GAP Analysis & Risk Assessment

Review of associated quality processes to identify compliance gaps, risks, and improvement opportunities.

Optimisation of Quality Processes for PV Compliance

Revision or development of SOPs and workflows to ensure full integration of PV requirements into the general QMS.

My Services – PV Quality Management Support

PV Input into Change Control and Deviation Systems

Establishing procedures to capture PV impacts in change assessments and structured deviation handling.

Archiving & Data Integrity Compliance for PV

Designing documentation and retention processes that meet GxP and pharmacovigilance requirements.

Audit-Ready PSMF Documentation

Ensuring all PV-relevant processes outside of the PV department are systematically traceable and aligned with authority expectations.

✔ Full Regulatory Compliance Without Complexity

Ensure that your pharmacovigilance requirements are fully embedded in your QMS – avoiding unnecessary duplicate structures.

✔ Clear Cross-Functional Interfaces

Transparent roles and responsibilities between PV, Quality, Regulatory Affairs, and other departments.

✔ Audit-Proof Documentation for the PSMF

Cross-functional processes are systematically captured, ready for audits, inspections, and PSMF updates.

✔ Risk Reduction Before Inspections

Identify and close compliance gaps early – avoiding audit findings and regulatory risks.

✔ Enhanced EU-QPPV Oversight

Give your EU-QPPV full visibility over all PV-relevant processes, as required under EU GVP Module II.

✔ Operational Efficiency and Collaboration

Streamlined integration of PV activities across your quality system improves collaboration and reduces administrative burden.

Your Benefits - Stronger Integration. Sustainable Compliance.

Ready to Optimize Your PV & Quality Processes?

Let’s discuss how we can seamlessly align your quality system with pharmacovigilance compliance requirements.
Get in touch for a tailored consultation.