Project: Outsourcing of in-country local Pharmacovigilance management.
Summary: Local PV support in 14 EU countries scaling up to 80 countries. Local QP, local literature searching, ICSR processing, local HA, regulatory intelligence.
This US based Biotechnology company had already chosen Arriello in 2009 to be their partner for outsourcing some of their EU Pharmacovigilance activities, both local and global. The scope covered all local PV needs - local QP contact, local literature searching, case processing, local regulatory intelligence and support with any ad-hoc regulatory submissions.
Arriello made all these processes faster and better by providing them with one point of contact for vendor management across 14 EU countries.
The client’s objective in 2016 was to expand the number of countries and regions from 14 EU to global coverage, and to harmonize their local Pharmacovigilance support in one place for every country where their product was present.