PV — Pharmacovigilance

Expert Pharmacovigilance Services for the Benelux & EU

Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce their risks and increase their benefits. M.P.C.A. International provides both global and local PV services, acting as your EU QPPV or Local Contact Person for the Benelux.

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EU QPPV & Deputy services
Local Contact Person and Deputy services for Benelux
Full ICSR management & MedDRA coding
PSMF management & GVP compliance
Open to 3-yearly external audits
About this service

Complete pharmacovigilance support

M.P.C.A. International can implement a complete pharmacovigilance system into your company and act as EU QPPV or Local Contact Person for Benelux, with full access to medical evaluation.

Alternatively, we can be responsible for parts of your pharmacovigilance system, or act as the Deputy QPPV or Deputy of the Local Contact Person / Local Safety Officer.

Our PV staff is fully and continuously trained following a yearly training plan. We are open to any assessment and external audit from your site and we adhere to three-yearly audits.

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PV services at a glance

EU QPPV & Deputy services
Local Contact Person (LCP) and Deputy services for Benelux
EudraVigilance account management
PSUR Repository (EMA)
XEVMPD management & update
PV training for your team
Safety physician services
Full service overview

Our pharmacovigilance services in detail

PSMF Management

Your Pharmacovigilance System Master File is crucial. Every MAH must have a PSMF in place. We maintain it, ensure it is audit-ready, and maintain it throughout your product lifecycle with an updated quality management system (QMS PV SOPs).

Safety Data Management (ICSR)

We manage your safety data and meet all ICSR requirements. Full support for each step of the ICSR handling process: from collection and translations to MedDRA and WHO drug coding, case assessment with quality control, medical review, proactive case follow-up and validated electronic case submission to EMA.

XEVMPD (Extended EudraVigilance Medicinal Product Dictionary)

We manage the mandatory European database (Article 57 database) for submitting and managing information on your authorized and investigational medicinal products.

Signal Detection & Risk Management

We manage the signal detection and benefit-risk profile of all your marketed medicinal products. Drug Safety Committee meetings keep you informed and involved at agreed intervals.

Literature Monitoring

Weekly global (worldwide) and local literature monitoring for the Benelux. We search local medical journals in Belgium, The Netherlands and Luxembourg for safety-relevant information.

Safety Physician Services

Our safety physicians are ready to support medical reviews of SUSARs and ICSRs, signal validation, aggregate reports, RMP and aRMM, across a wide range of therapeutic areas.

Frequently asked questions

Pharmacovigilance services

What is pharmacovigilance and why is it required?
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. It is a legal requirement for every marketing authorisation holder in the EU, to ensure the ongoing safety of medicines.
What is an EU QPPV and do you provide one?
The EU QPPV (Qualified Person responsible for Pharmacovigilance) is the person legally responsible for the pharmacovigilance system of a marketing authorisation holder in the EU. Yes, M.P.C.A. International provides EU QPPV and Deputy services, as well as Local Contact Persons and Deputies for the Benelux.
What is a Local Contact Person for pharmacovigilance?
Several countries require a local pharmacovigilance contact person at national level, working under the EU QPPV. We act as the Local Contact Person for the entire Benelux, handling local safety reporting obligations in Belgium, the Netherlands and Luxembourg.
Which pharmacovigilance tasks can M.P.C.A. take care of?
We handle safety data management, ICSR (Individual Case Safety Report) processing, maintenance of the Pharmacovigilance System Master File (PSMF), literature monitoring, signal detection, CIOMS reporting and XEVMPD management.
How do I set up a pharmacovigilance system with M.P.C.A. International?
You can contact our team for a no-obligation consultation. We assess your safety obligations and propose a tailored pharmacovigilance setup for the Benelux and beyond.
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Need a QPPV or pharmacovigilance system?

Our pharmacovigilance team is ready to implement a complete PV system for your company or act as your EU QPPV, ensuring full compliance and patient safety.

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