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Pharmacovigilance

As required by European and Italian regulations, every AIC holder must have, on a stable and continuous basis, a pharmacovigilance service manager and is required to keep detailed records of all suspected adverse drug reactions observed in Italy, the European Union or a third country.

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:
– QPPV and Local Contact Person LCP Service.
– Support in Pharmacovigilance activities, including maintenance of PSMFs and related SOPs
– Safety Database management, case processing, and medical evaluation of ICSRs
– Indexed and non-indexed literature search
– Signal Management
– Management of the database “Art 57”
– Pharmacovigilance Training