Pharmacovigilance outsourcing has become crucial for biotech companies to remain compliant and safeguard patients. When you bring a drug to market in Europe or globally, your Qualified Person for Pharmacovigilance (QPPV) serves as your first line of defense. The right QPPV ensures you stay compliant, avoid delays, and maintain control over your product’s safety. However, not all QPPV partners are equal. In the biotech industry, making a mistake can mean losing time, trust, or your market authorization entirely. In this article, we are going to explore what makes a good QPPV partner, why the Marketing Authorisation Holder (MAH) bears critical responsibility, and how to build a globally robust and inspection-ready compliance system.
What is a QPPV’s role
The European Medicines Agency (EMA) mandates that every Marketing Authorisation Holder (MAH) appoint an EU QPPV. This individual is legally responsible for establishing, implementing, and overseeing the MAH’s pharmacovigilance system. Their key responsibilities include but not limited to:
- 24/7 availability to regulatory authorities
- Real-time access to all safety data
- Oversight of risk management plans and safety reporting
- Maintenance of the Pharmacovigilance System Master File (PSMF)
- Signal detection and escalation
- Communication with EU regulatory bodies
Although the EU QPPV holds ultimate responsibility, several EU member states impose national-level requirements for additional local PV representation. These local QPPVs or PV contacts ensure swift, localized regulatory communication, and facilitate inspections and reporting. They are not optional in countries where mandated by law.
Why local QPPVs are critical outside the EU
While the EU QPPV oversees the overall pharmacovigilance system, many countries and regions outside the EU, including the UK, CIS, and MENA, need individuals based in-country who fulfill national regulatory obligations. That’s where local QPPVs step in, solving real operational and regulatory challenges.
For example:
- In Saudi Arabia, local QPPVs residing in the country and fluent in Arabic, must submit Individual Case Safety Reports (ICSRs) through the national reporting portal, in Arabic, within strict timelines.
- In Kazakhstan, regulators require a local pharmacovigilance contact person residing in the country, able to provide face-to-face communication and manage locally stored documents.
- In the UK, post-Brexit rules require a UK Qualified Person for Pharmacovigilance (UK QPPV) or a National Contact Person for Pharmacovigilance if the EU QPPV resides outside the UK who must be available for MHRA queries during UK business hours.
In these countries, local QPPVs are legally required and must be embedded in local operations. Therefore, local QPPVs navigate these country-specific expectations, handle reporting obligations, respond to health authority inquiries, and monitor the risk benefit of the products at local level. They also bridge cultural nuances and prevent delays caused by language or procedural mismatches.
In summary, they transform global systems into local actions without hindering your progress.
A notable regional model exists within the Eurasian Economic Union (EAEU)—comprising Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan. MAHs must appoint an EAEU QPPV who is responsible for pharmacovigilance oversight across all member states. This role functions as a regional QPPV, similar in scope to the EU QPPV, with cross-border responsibilities aligned with ICH and EAEU GVP standards. However, despite the harmonized framework, certain member states—such as Kazakhstan and Belarus—still require local QPPVs or in-country pharmacovigilance contact persons to manage national submissions, maintain local documentation, and interface with regulators during inspections.
What to look for in a QPPV partner
So, when looking for a QPPV, you need to be reminded that you’re trusting someone with your safety system. You need to ask yourself:
1. Are they available 24/7, and do they have authority?
Your QPPV must be reachable at all times. They also need formal authority within your pharmacovigilance system, meaning the ability to halt distribution, escalate safety concerns directly to leadership, and enforce corrective actions without delay. This authority isn’t symbolic or best practice; regulators will assess whether your QPPV can take decisive action when patient safety is at risk. If they can’t, your system is not compliant.
2. Do they cover local markets?
As it was previously covered, it is important that your provider offers regional and in-country pharmacovigilance services where applicable, not just EU-based support. This avoids delays in markets like the UK, Russia, or Saudi Arabia.
3. Are they part of a larger safety system?
Pharmacovigilance today is too complex for one person to manage alone. A competent QPPV must be backed by a full safety operations team, including safety scientists, case processors, signal detection experts, safety physicians and QA specialists, along with validated tools and a strong Quality Management System. This support structure ensures that ICSRs are processed on time, PSMFs are always inspection-ready, and regulatory changes are implemented without disruption. Without it, even the most experienced QPPV can become a bottleneck instead of a safeguard.
4. Have they been through inspections?
Expertise matters because inspections aren’t theoretical. On the contrary, they’re stressful, time-sensitive, and often unannounced. Your QPPV partner should know exactly how to prepare EMA and local inspections and audits, manage real-time Q&A with inspectors, and resolve findings through targeted CAPAs.
For biotech companies with lean teams, having someone who’s already handled multiple inspections can prevent small gaps from turning into regulatory setbacks.
Why choose Biomapas
Biomapas helps MAHs stay compliant in the EU, CIS, MENA, and beyond. Our team provides:
- Fully compliant EU QPPV/EAEU regional services
- Local QPPVs and safety experts across key markets
- An integrated pharmacovigilance system that’s inspection-ready
Whether you’re launching your first product or expanding into new regions, we make sure your QPPV function is responsive and respected by regulators.
Want confidence in your compliance wherever you go next?
Contact us to learn how our QPPV and pharmacovigilance services support biotech teams around the world.
