Pharmacovigilance

• Local contact person for PV (Art.R5121-164)
• Management of local PV, i.e. receiving, archiving and following up adverse drug reactions received in France
  • Submitting ADR forms to Client PV organization
  • Submitting ADRs (ICSRs) to ANSM, if applicable
• Supporting local submission of Periodic Safety Update Reports (PBRERs) and other safety documents and ensure compliance with local requirements
• Supporting the local implementation of risk minimisation measures