In today’s complex regulatory environment, pharmaceutical and biotech companies are under growing pressure to stay compliant while remaining agile and cost-effective. One area where this balance is especially critical is pharmacovigilance, and more specifically, the role of the EU Qualified Person for Pharmacovigilance (QPPV). An EU QPPV is legally required and critical for ensuring patient safety and meeting European regulatory requirements. As Pharmacovigilance requirements continue to evolve, the role of the EU QPPV is becoming more strategic and compliance intensive , as such, many companies are discovering that outsourcing this role is not just a practical solution but a strategic move that delivers flexibility, expertise, and peace of mind.

Here's a breakdown of the key advantages of outsourcing an EU QPPV:

Cost efficiency

• Reduced overhead: Hiring a full-time, in-house QPPV involves salary, benefits, training, and infrastructure costs. Outsourcing provides access to expertise without those long-term financial commitments.
• Flexible pricing models: Service providers offer flexible arrangements (e.g., retainer, hourly, or per-project) that can be tailored to your company’s size and pipeline stage.

Access to expertise

• Specialized knowledge: Outsourced QPPVs often come from organizations focused solely on pharmacovigilance, meaning they are up to date with the latest regulations, best practices, and authority expectations.
• Multi-client experience: They have broad exposure to various therapeutic areas and regulatory interactions, which can be a valuable asset.

Regulatory compliance

• EU regulations: The EU requires that Marketing Authorization Holders (MAHs) have an EU-based QPPV. Outsourcing helps non-EU companies or small firms meet this requirement efficiently.
• 24/7 availability: EU QPPV 24/7 availability, by means of one or more Deputy EU QPPVs, is provided thus complying with the EMA legislative requirement for the EU QPPV role.

Operational scalability

• Rapid setup: Outsourced QPPVs can be deployed quickly, which is especially helpful when entering the EU market or preparing for a Marketing Authorisation Application (MAA).
• Support during peak periods: Companies can scale services up or down depending on their pipeline stage or regulatory workload.

Inspection readiness

• Streamlined audits & inspections: Outsourced QPPVs are inspection-ready and have more hands-on experience with inspections, which reduces the risk of findings and the internal resources needed for preparation.

Geographical and regulatory coverage

• EU presence: For companies outside of the EU, outsourcing is a practical way to have an EU-resident QPPV, as legally required.
• Multilingual & cross-border capabilities: Vendors can provide services in multiple languages and liaise with various national competent authorities.

Why outsource your EU QPPV function?

Managing pharmacovigilance in today’s regulatory environment requires more than just compliance. It demands agility, deep expertise, and the ability to scale quickly. For many pharma and biotech companies, outsourcing the EU QPPV role to a specialized partner offers a smart, strategic path forward. It reduces overhead, accelerates market readiness, and ensures 24/7 coverage by professionals who live and breathe lifecycle safety. Most importantly, it allows internal teams to stay focused on innovation while trusted experts handle the complexities of regulatory oversight.

Why choose IQVIA as a trusted EU QPPV partner?

IQVIA brings together one of the largest global networks of safety professionals (over 4,000) with a full suite of pharmacovigilance services that span the entire safety lifecycle. From medical information and adverse event processing to signal detection, aggregate reporting, and both Local and EU QPPV services, IQVIA delivers flexible solutions tailored to your size, pipeline, and market strategy.

What sets IQVIA apart is its integrated model. By combining EU QPPV services with broader safety operations, IQVIA enables real-time access to safety data, empowering QPPVs to act swiftly and decisively. And with unified oversight across both EU and local markets, companies benefit from consistent compliance, streamlined communication with regulators, and a partner who understands the full picture.