PHARMACOVIGILANCE

Pharmacovigilance System Outsourcing

 

Provision of EEA Qualified Person for Pharmacovigilance (EEA QPPV)

PrimeVigilance offers experienced EU Qualified Person for Pharmacovigilance (QPPV) and Deputy QPPVs with extensive knowledge and experience of the industry.

Safety Data Exchange Agreements (SDEA)

Safety Data Exchange Agreements are legal written contracts ensuring that all safety data regarding a licensed product makes its way quickly and reliably back to the marketing authorisation holder so that they may fulfil their legal obligations to aggregate safety data and to submit safety reports in a timely manner.

The Global Drug Safety database (ARISg™)

A 21CFR compliant, fully validated safety database is an essential part of Good Pharmacovigilance Practice.

Pharmacovigilance System Master File (PSMF)

EU Directive 2010/84/EU (amending 2001/83/EC) requires each application for Marketing Authorisation (MA) for the EU to have a Pharmacovigilance System Master File (PSMF) in place including the named Qualified Person responsible for Pharmacovigilance within the EEA.

Provision of a National Person Responsible for Pharmacovigilance (NPRP)

PrimeVigilance offers an extensive network of “Local QPPVs” or more accurately known as National Persons Responsible for Pharmacovigilance (NPRP) in the European Economic Area (EEA) countries where the provision of an NPRP is required by national law at the time a market authorization is submitted or when a product receives its marketing authorization.