As required by European and Italian regulations, every AIC holder must have, on a stable and continuous basis, a Qualified Pharmacovigilance Person (QPPV) and an established pharmacovigilance system.

Since 2008, VI.REL has been acting as a Service Provider capable of meeting the different needs of Clients: from comprehensive management of Pharmacovigilance activities to spot activities.

Below is a list of the services we offer to our clients:

  • Qualified Person for Pharmacovigilance (QPPV) and Local Contact Person (LCP).
  • Pharmacovigilance Physician
  • Support in Pharmacovigilance activities, including the drafting and maintenance of PSMFs and related SOPs
  • Case management and follow-up
  • Indexed and non-indexed literature search
  • Signal management and Signal Detection Report writing.
  • Management of the database “Art 57”
  • Pharmacovigilance Training
  • Safety Database Management,
  • Drafting of risk-management plan (RMP) and Periodic Safety Update Report (PSUR)
  • Pharmacovigilance Audits, Due Diligence