Pharmacovigilance:

  • Appointment of Qualified Person for Pharmacovigilance (QPPV).
  • Appointment of a Medically Qualified Person (doctor) to support the QPPV.
  • Appointment of the contact person in Portugal for matters of pharmacovigilance 24/7.
  • Tracking Periodic Security Reports / RPS submission calendar management.
  • Research and weekly submission of Adverse Drug Reactions (RAMs) in the international literature.
  • Weekly Adverse Drug Reactions (RAMs) survey in local literature.
  • Training in pharmacovigilance for current and new employees.
  • Supply and implementation/adaptation of SOP’s.
  • ICSR (Individual Case Safety reports) management,including,treatment, causality analysis and transmission of expedited reports of RAMs by EudraVigilance system.
  • Preparation of the Risk Management Plan.
  • Elaboration of Pharmacovigilance System Master File and Summary of the PSMF
  • Signal detection in pharmacovigilance, including review of EVDAS.
  • Signal validation procedure.
  • Support for post-authorization studies of safety and efficacy (PASS and PAES).
  • Risk management systems.
  • Pharmacovigilance quality system.
  • Monitoring of risk minimization measures.
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