Pharmacovigilance & Cosmetovigilance

Pharmacovigilance:

  • EUQPPV/Local pharmacovigilance contact person
  • PV in clinical trials and post-authorisation
  • Set up & implementation of pharmacovigilance system
  • Bibliographic review
  • Complete case management: processing of suspected adverse reactions
  • Eudravigilance electronic submission (XEVMPD, PSMF code, reporting of ICSRs)
  • PV SOPs
  • Pharmacovigilance System Master File (PSMF)
  • Periodic Safety Update Reports (PSUR)
  • Risk Management Plans (RMP)
  • PV agreements
  • PV training to staff
  • Audit of pharmacovigilance system

Cosmetovigilance:

  • Set up & implementation of cosmetovigilance system
  • Management & reporting of serious undesirable events

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