Global Qualified Person Responsible for Pharmacovigilance (QPPV)

A QPPV establishes and maintains a pharmacovigilance system, provides Health Authorities with information relevant to product safety and is delegated by the MAH to be personally responsible for the safety of human pharmaceutical products marketed by a company in a given country or region.

Competency Standard

 

Part 1 - General PV Knowledge:

The candidate’s general PV knowledge is evaluated via an online AI-proctored multiple-choice test covering these areas:

  • Pharmacovigilance aim, scope, and terminology
  • Ethics and leadership in PV
  • PV system architecture and stakeholders
  • Global regulatory landscape and data privacy
  • Societal impact and public-health importance

Number of questions: 100
Length: 90 minutes
Score needed to pass: 80%
Number of attempts: 3

Register here

Part 2 - Specialized QPPV Knowledge:
(coming soon)
The candidate’s QPPV-specific knowledge is evaluated via an online AI-proctored multiple-choice test covering these areas:

  • Oversight and governance of PV systems
  • Risk and signal management responsibilities
  • Interaction with quality and product defect systems
  • Communication with authorities and partners
  • Safety decision-making and documentation standards

Part 3 - Regulatory Intelligence:
(coming soon)
This online test evaluates knowledge of PV-relevant regulatory frameworks covering:

  • Regional and national PV legislation
  • Local reporting obligations
  • Inspection readiness and compliance systems
  • Regulatory variations and authority interactions

Part 4 - Oral Exam:
(coming soon)
Assessed via an Examination Board interview evaluating applied PV competence across:

  • Strategic and ethical decision-making
  • Leadership and stakeholder communication
  • Analysis and reasoning in complex PV scenarios
  • Professional independence and judgement

*ISoP GPPC Certification – QPPV Role. The certification includes: 1) QPPV Knowledge Test Step 1 – PV Knowledge. 2) Step 2 – QPPV Specialisation. 3) Step 3 – Local Regulations.  4) Verbal Interview by the Examination Board. Each step costs €400 for high-income countries. All steps must be completed within 300 days in order. A certificate is issued per step; full qualification is granted after all four steps.