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