Why Is Reconciliation Essential in Pharmacovigilance?

Reconciliation of safety data is a critical pharmacovigilance activity that ensures adverse drug reaction (ADR) information is complete, consistent, and aligned across all relevant systems and stakeholders.

According to EU GVP Modules VI and IX, Marketing Authorisation Holders (MAHs) must regularly reconcile safety data between internal systems, affiliates, distribution and license partners, and service providers.

Failure to perform reconciliation in a structured and timely manner may result in data inconsistencies, incomplete case reporting, and significant compliance risks during audits and inspections.

Regulatory Requirements & Common Challenges

To maintain a compliant pharmacovigilance system, companies must:

Establish a structured, risk-based reconciliation process tailored to their specific data sources
Perform regular, documented reconciliations with internal and external stakeholders
Detect, resolve, and document discrepancies without delay
Ensure traceability and oversight to support inspection readiness

Many companies struggle with implementing reconciliation processes in pharmacovigilance – often due to a lack of clarity on what exactly needs to be reconciled and how to ensure compliance with EU GVP.

Pharmacovigilance Reconciliation

Ensuring Data Consistency and Compliance

Process Design & Implementation

Development of a risk-based, tailored reconciliation framework that ensures transparency, traceability, and long-term compliance.

Considering International Reconciliation Requirements

Implementation of reconciliation processes for signal and information exchange, in accordance with international pharmacovigilance standards.

Partner & Vendor Reconciliation

Conducting and supporting routine reconciliations with affiliates, license partners, CROs, and database vendors – including full documentation and issue tracking.

My Services – Structured Pharmacovigilance Reconciliation for Sustainable Compliance

I help you design and implement a compliant reconciliation process in line with EU GVP and international pharmacovigilance requirements – from concept to execution.

Tool Selection & Setup

Support in selecting or developing reconciliation tools that enable structured, efficient, and audit-ready data comparison.

Deviation & CAPA Management

Root cause analysis of discrepancies, escalation management, and implementation of corrective and preventive actions (CAPA).

Audit & Inspection Readiness

Creation of SOPs, documentation of reconciliation activities, and training to ensure a robust, audit-proof process.

Your Benefits – Compliance, Clarity, and Control

✔ Regulatory Compliance & Audit Readiness

Full alignment with EU GVP and global PV guidelines – supported by structured documentation and a complete audit trail.

✔ Data Accuracy & Risk Mitigation

Reduced discrepancies, fewer data losses, and improved reliability of your safety data resulting in patient safety.

✔ Up-to-Date Oversight of Partner Performance

Clear visibility into your partners’ and vendors’ compliance – enabling early detection of issues or deviations.

✔ Efficient & Scalable Processes

Optimised reconciliation workflows that reduce manual effort and scale with your PV partner landscape.

✔ End-to-End Support & Expertise

From design to execution – I guide you through every step, ensuring a seamless and inspection-ready reconciliation process.

Hands working on a laptop representing pharmacovigilance data reconciliation

Get in Touch

Need Support with Your PV Reconciliation?

Let’s talk about how we can strengthen your reconciliation process and ensure full regulatory compliance.