Engages in pharmacovigilance and risk-management systems to ensure patient safety and risk-minimisation


  • Knows the requirements for reporting adverse events and demonstrates an ability to report adverse events and perform a causality assessment.
  • Designs and executes methods to monitor and assess safety data and to carry out continuous safety monitoring.
  • Analyses and summarises safety data from all sources; presents conclusions.
  • Performs a benefit-risk evaluation; able to identify if new information will alter the benefit-risk balance and effect the safety of patients.
  • Identifies and manages risks to guide appropriate use of a medical product.
  • Communicates new safety findings effectively and recommends appropriate risk management strategies and risk minimisation activities.
  • Locates safety information associated with a medical product and provides advice on its safe and effective use.

Evidence to inform decision

  • Authorship and/or review of text in core safety documents
  • Written advice on the safe use of a medical product
  • Individual Case Safety Report (ICSR)
  • Safety monitoring
  • Risk management and mitigation activities
  • WPBAs
  • Core competencies
  • ES report
  • Course assessment
  • DPM

Mapping to GPCs

Domain 2 – Professional skills:

  • Practical skills
  • Communication and interpersonal skills

Domain 3 – Professional knowledge:

  • Professional requirements

Domain 5: Capabilities in leadership and team working

Domain 6 – Capabilities in patient safety and quality improvement:

  • Patient safety
  • Quality improvement

Domain 7 – Capabilities in safeguarding vulnerable groups

Domain 9 – Capabilities in research and scholarship