---
title: "Scaling Pharmacovigilance in Europe"
description: "As pharma SMEs and biotechs grow, pharmacovigilance systems that once worked well can quickly become a bottleneck. This white paper breaks down how to build a pharmacovigilance (PV) setup that scales with your business, without losing compliance or control."
url: https://qbdgroup.com/en/downloads/scaling-pharmacovigilance-europe
type: "White paper"
language: en
published: 2026-05-21
author: "Almudena del Castillo, Division Head Vigilance"
category: "Pharmacovigilance"
publisher: "QbD Group"
citation: "QbD Group, \"Scaling Pharmacovigilance in Europe\", https://qbdgroup.com/en/downloads/scaling-pharmacovigilance-europe"
---
# Scaling Pharmacovigilance in Europe
> As pharma SMEs and biotechs grow, pharmacovigilance systems that once worked well can quickly become a bottleneck. This white paper breaks down how to build a pharmacovigilance (PV) setup that scales with your business, without losing compliance or control.

## About this white paper

Growing your product portfolio, entering new markets, or going through an acquisition all put pressure on your pharmacovigilance system. What worked at an early stage may no longer be fit for purpose when operations become more complex and distributed across multiple countries, vendors, and stakeholders.

In this white paper, Almudena del Castillo, Head of QbD's Global Vigilance Division, shares a **practical framework for scaling pharmacovigilance in Europe**. From choosing the right operating model to building governance structures that hold up under regulatory scrutiny, this guide gives pharma SMEs and biotechs **a clear roadmap for sustainable PV growth.**

## What you'll learn

- Why scalability in pharmacovigilance matters
- How to choose the right PV operating model
- Why governance is the backbone of scalability
- How to organize for scale: data, systems and people
- Real scenarios of PV scalability

## Download the white paper

Build a pharmacovigilance system that scales with your business, without losing compliance or control.

Complete the form to access the full white paper and discover a practical roadmap for sustainable PV growth in Europe.
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Source: https://qbdgroup.com/en/downloads/scaling-pharmacovigilance-europe — © QbD Group. Quote freely with attribution and a link back.