Pharmacovigilance (PV) team is one of the core parts of BK . Our PV Team members are highly focused and specialized in clinical trial safety management, case processing and safety reporting solutions offered to pharma and biotech industries.
BK PV solutions ensure:
PV System fundamentals:
The PV system is compliant with the European and US pharmacovigilance legislation. BK PV processes are based on GCP, GVP (Good Pharmacovigilance Practice) and other regulations, guidelines and best practices applicable for safety management during clinical research and in the post-marketing environment.
Quality and performance KPIs (examples):