Competency information


Write up the findings of the risk assessment as a formal report and present the findings to an internal meeting, including an action plan.


  • Purpose of pharmacovigilance risk assessment.
  • Committee for Medicinal Products for Human Use.
  • Detection, assessment, minimisation and communication relating to the risk of adverse reactions.
  • Therapeutic effect of the medicinal product.
  • The design and evaluation of post-authorisation safety studies.
  • How to perform pharmacovigilance risk assessment and audit:
    • risk identification
    • risk measurement
    • analysis and evaluation (risk benefit evaluation)
    • risk management
    • monitoring the effect of risk management.
  • Correct level of approval/authorisation.
  • Monitoring clinical outcomes, positive and adverse drug reactions (ADR).
  • Reporting any adverse drug reactions.
  • Summary of product characteristics (SmPC), including likely frequency and severity of adverse drug reactions.
  • Reporting mechanisms within and beyond your organisation.

Relevant learning outcomes

# Outcome
# 3 Outcome Perform pharmacovigilance risk assessments.