About this white paper
Key topics covered in this resource
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
Key takeaways from this document
- 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
About the Author
Former QPPV · Division Head Vigilance & Country Manager Spain
Almudena leads pharmacovigilance strategy and operations at QbD Group as Division Head of Vigilance and Country Manager for Spain, helping pharma and biotech companies build robust drug safety systems.
