EU pharmacovigilance regulations require each marketing authorisation holder, national competent authority and EMA to operate a pharmacovigilance system. Grove provides a network of local QPPV (Qualified Person Responsible for Pharmacovigilance) experts in Poland, Hungary, Czech Republic, Slovakia, Romania, Bulgaria, Slovenia, Croatia, Latvia, Estonia, Lithuania, Serbia, Montenegro and Russia as a solution for pharmacovigilance issues at a national level. These highly skilled and continuously trained professionals provide a full range of pharmacovigilance and medical device vigilance services to enable Grove clients to maintain compliance with EU drug safety and pharmacovigilance requirements.
Our local pharmacovigilance resources are available on a 24-hour/7 day per week basis to receive notices for any safety information, safety issue or signal for your products. The local contact person reports to the client’s European qualified person responsible for pharmacovigilance activities, in accordance with the laws and regulations applicable in a country.
Grove’s local qualified personnel take the responsibility for the collection and accurate documentation of all safety information received on national level and assists with follow-up. Safety information is forwarded to the client within the timeframes and format specified in individual Safety and Medical Information Agreements. Furthermore, we undertake local MLM (medical literature monitoring) and medical scientific literature and notify clients of published information regarding the products.
Moreover, our pharmacovigilance activities at a national level cover the following areas: