Pharmacovigilance Print E-mail
  • Pharmacovigilance system design, implementation and maintenance.s_farmacovigilancia2
  • Continuous, up to date, pharmacovigilance advice and consultancy. 
  • Standard Operating Procedures for pharmacovigilance.
  • Preparations, review, integration and update.
  • Documents:
    • Periodic Safety Updated Reports.
    • Critical evaluation of the benefit risk balance.
    • Clinical overviews.
    • Risk Management Plans.
    • Pharmacovigilance system summary.
    • Elaboration/Update Pharmacovigilance master file.
  • Case Management:
    • Management and reporting of suspected adverse reactions.
    • MedDRA coding.
    • Management and support with EudraVigilance Registration.
    • Electronic reporting.
    • Compliance Monitoring.
  • Literature searches: Periodical and ad hoc.
  • Advice on pharmacovigilance databases.
  • Post-authorization safety studies (Phase IV), Pharmacoepidemiology and drug use.
  • Review of safety agreements for pharmacovigilance.
  • Technical (Spanish/English) translations.