Why Is Partner Management Essential in Pharmacovigilance?

Pharmacovigilance activities are frequently outsourced to external partners, such as distributors, license partners, or service providers. While delegation is allowed, the marketing authorisation holder (MAH) remains fully responsible for the PV system and its compliance.

EU GVP requires not only clearly defined responsibilities through contracts but also robust oversight mechanisms to monitor delegated activities and ensure regulatory compliance. Without a structured partner management approach, companies risk non-compliance, delayed safety data exchange, and critical findings during inspections.

In practice, this means all PV-relevant partnerships must be clearly documented, regularly assessed, and actively managed – both contractually and operationally.

Partner Management in Pharmacovigilance

Oversight of External Partners – Structured, Compliant, and Aligned with Your PV System

Partner Management Process Design & Implementation

Designing and implementing a tailored process for partner oversight – ensuring transparency, up to date, and inspection readiness across all delegated pharmacovigilance activities.

Establishing & Maintaining a PV Partner Overview

Developing and maintaining a structured tool for PV partner management that captures all essential data – including partner entities, territories, products, distribution status, marketing authorisations, PV agreement status, key contacts and timelines. This centralised system facilitates oversight, collaboration, and regulatory compliance.

Controlled Update Mechanism for Partner Data

Implementing processes for changes in partner information (e.g. new contacts, territories). This ensures data integrity, traceability, and real-time compliance.

My Services

Partner Management for a Compliant PV System

Pre-Qualification of PV Partners

Supporting your due diligence processes and performing audits to evaluate the suitability and compliance of prospective pharmacovigilance partners.

Facilitating Communication, Collaboration & Document Sharing

Acting as interface between your internal PV teams and external partners – enabling structured, GVP-compliant collaboration. This includes establishing clear communication, controlled document sharing (e.g. SmPCs, PILs, RMPs) and escalation pathways.

Partner Training & Support

Providing customised training sessions for external partners to ensure they understand and fulfil their pharmacovigilance obligations.

I support you in establishing a structured approach to partner management that aligns seamlessly with your PV system and EU GVP expectations.

Working with external partners doesn’t have to mean losing control. With my support, you gain a scalable and inspection-ready partner management system – tailored to your PV setup.

✔ Regulatory Compliance – Enabled Through Structured Oversight

A well-structured partner overview helps you verify compliance, assess delegated responsibilities, and identify potential risks – in line with EU GVP.

✔ Clarity in Complex Partner Landscapes

Whether managing a few distributors or a global network of licensing partners – I help you stay on top of territories, agreements, key contacts and timelines.

✔ Standardised Approach

Benefit from a clear, auditable process to qualify, monitor, and manage PV partners – reducing variability and increasing transparency.

✔ Improved Collaboration with PV Partners

A structured system lays the foundation for smoother cooperation, clearer expectations, and faster alignment with partners – even across time zones and cultures.

✔ Inspection Readiness – Proven in Practice

Based on experience from numerous audits and inspections, I know what authorities expect – and I help you meet those expectations with confidence.

Your Benefits – Full Control and Oversight

Handshake representing global partnership in pharmacovigilance

Ready to Strengthen Your PV Partnerships?

Ensure Compliance & Strengthen Collaboration – Let’s Optimize Your PV Partner Management!

Let’s build a structured and compliant partner management system tailored to your needs.

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