Pharmacovigilance

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
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