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Clinical and Medical Affairs

QPPV Services.

Flexible Qualified Person for Pharmacovigilance (QPPV) solutions on demand. We provide experienced experts as an outsourcing solution, interim QPPV, or for legally compliant backup designation for your existing pharmacovigilance structures.

Senior QPPV in a formal meeting with drug regulatory authorities

What is a QPPV? The Qualified Person Responsible for Pharmacovigilance (QPPV) is a legally required role under GVP Module I and EU Directive 2001/83/EC. The QPPV bears personal responsibility for the marketing authorization holder’s entire pharmacovigilance system—24/7—to the EMA and national authorities. ENTOURAGE provides experienced QPPVs as an outsourcing, interim, or backup solution.

Why is the QPPV role so challenging for companies?

The QPPV bears significant personal and legal responsibility toward European authorities. Finding the right person for the role is often difficult:

  • Qualified and experienced QPPVs are in extremely short supply on the job market and are correspondingly expensive.
  • Startups and SMEs, in particular, are often unable to afford a high-salary, full-time QPPV position internally.
  • The mandatory legal requirement to provide coverage in the event of the QPPV’s absence due to vacation or illness (backup) is often not adequately addressed.
  • The ever-increasing GVP requirements often place an excessive burden on less experienced or isolated internal QPPVs.
Do you currently have an audit-proof, documented backup plan for the QPPV in case of sudden absences?
Signing of an official QPPV contract mandate

Our QPPV services.

We offer flexible, legally compliant QPPV models that can be tailored precisely to the size of your company and its current stage in the business lifecycle.

Comprehensive QPPV Outsourcing Service
A highly qualified ENTOURAGE QPPV fully assumes the legally required QPPV responsibilities. This includes communication with regulatory authorities, signing the PSMF, and representing the company before the EMA. A compliant mandate provides you with contractual protection.
Interim QPPV & Temporary Replacement
Seamless and immediate coverage in the event of the sudden absence of the internal QPPV due to illness, resignation, or parental leave. We ensure immediate integration into existing PV systems without any loss of data.
Backup QPPV for existing structures
Formal and legally compliant backup QPPV designation as an essential safeguard for your existing internal QPPV. All European regulatory requirements are met—without any reliance on full outsourcing.
QPPV Training for Internal Candidates
Structured intensive training for your internal QPPV candidates: GVP modules, PSMF responsibilities, communication with regulatory authorities, SAE management, and signal detection. The perfect preparation for significant regulatory responsibilities.

How does a QPPV engagement with ENTOURAGE work?

From contract award to ongoing PV operation—in 5 phases.

01

Needs Assessment

Analyze the product portfolio, existing PV structures, and regulatory requirements.

02

QPPV mandate

Conclude the contract, draft a GVP-compliant mandate, and notify the QPPV to the EMA and national authorities.

03

PSMF & Onboarding

Review/create the Pharmacovigilance System Master File. Integrate the QPPV into existing processes.

04

Ongoing operations

Signal detection, PSUR/PBRER, communication with regulatory authorities, SAE management during routine operations.

05

Audit Support

Preparation for and support during GVP inspections conducted by the EMA or national authorities.

PV
“The QPPV role is not a mere formality—it is the PV system’s last line of defense. Inspectors first verify whether the QPPV truly understands and fulfills their responsibilities.”
Pharmacovigilance Team, ENTOURAGE

Frequently Asked Questions About QPPV Services.

What are the specific legal requirements for a QPPV?
The QPPV must be available on a permanent and uninterrupted basis (24/7 if necessary). The QPPV must be based in the EU and must have both proven pharmaceutical/medical expertise and extensive pharmacovigilance experience. The QPPV bears personal and legal responsibility for the marketing authorization holder’s pharmacovigilance system.
Can the QPPV function be fully outsourced?
Yes, absolutely. GVP Module I explicitly permits the complete outsourcing of the QPPV function to a qualified external consulting firm. This requires a clearly defined, written QPPV mandate.
What is a QPPV backup, and why is it necessary?
GVP Module I stipulates that the QPPV position must be filled at all times—even during vacation or illness. An officially designated backup QPPV is mandatory. Inspections regularly reveal that many companies lack precisely this backup arrangement.
How quickly can ENTOURAGE provide a QPPV?
Normally within 4–10 business days after the contract is signed. In urgent cases (such as the sudden loss of an internal QPPV), integration is possible within 24–48 hours.
For which companies does QPPV outsourcing make sense?
This is particularly useful for startups, SMEs, and companies with few marketing authorizations that cannot afford to fund a high-salaried, full-time QPPV position internally. It is also suitable for companies without an EU branch that require an EU-based QPPV.
How much does QPPV outsourcing cost?
Pricing depends on the product portfolio, complexity, and desired service level. A backup QPPV is significantly more cost-effective than full outsourcing. Contact us for a customized quote.

Additional expertise in the field of drug safety.

Expertise

Pharmacovigilance

Development and optimization of GVP-compliant systems.

 Expertise

Signal Detection

Systematic safety signal management for pharmaceuticals.

 Expertise

QP on Demand

Qualified Person for batch release — provided at short notice and in compliance with GMP.

No compromises when it comes to GVP responsibility.

Secure your pharmacovigilance system with our highly qualified interim or backup QPPVs and pass any regulatory audit with ease.

Submit a project inquiry.

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