Pharmacovigilance services in Bulgaria

For those involved in medicines/medicinal products and medical devices in Bulgaria developing and maintaining an approved approach to pharmacovigilance and medical device vigilance is vital. As an EU-member state, Bulgaria adheres to EU pharmacovigilance requirements, but meeting these needs given the complexities associated with the local healthcare sector structures/systems can prove challenging.

That said, the Bulgarian talent pool is such that at least one pharmaceutical company has been encouraged to centralize their European pharmacovigilance activities in Bulgaria.

LOCAL PV EXPERTISE IS VITAL FOR PHARMACOVIGILANCE SERVICES IN BULGARIA

The MAH must implement and regularly audit a pharmacovigilance system for Bulgaria. All serious adverse events identified in Bulgaria must be reported electronically to the EMA within 15 days as is the case in other EU member states. Similarly, non-serious adverse events identified in Bulgaria should be reported electronically to the EMA within 90 days.

Any marketing authorization holder (MAH) in Bulgaria must nominate a local contact in Bulgaria to work with a local QPPV (qualified person responsible for pharmacovigilance) responsible for pharmacovigilance in Bulgaria. Details of the local contact must be submitted to the Bulgarian Drug Agency.

With a comprehensive understanding of local pharmacovigilance requirements in Bulgaria Grove provides a range of pharmacovigilance services in Bulgaria within a fully comprehensive outsourced local pharmacovigilance services solution in Bulgaria.


A FULLY COMPREHENSIVE SOLUTION FOR PHARMACOVIGILANCE SERVICES IN BULGARIA

Grove offers a fully comprehensive outsourced solution for pharmacovigilance services in Bulgaria for clients unable or unwilling to invest in the development of relevant systems on their own account.
With proven success over two decades, Grove has developed a comprehensive package which meets the needs of both its individual clients and the relevant authorities. The service is continually developed to ensure it remains relevant and is bespoke to the client in question.

For those involved in pharmaceuticals/medicines/drugs and medical devices, the pharmacovigilance service package comprises:

  • Full-time (24/7) service of a local QPPV (Qualified Person Responsible for Pharmacovigilance)
  • 24-hour cover for adverse event reporting
  • End-to-end processing of safety information
  • Production of PSUR (periodic safety update reports)
  • Production of individual case study reports
  • Access, as and when appropriate, to local healthcare professionals and authorities
  • MLM (medical literature monitoring) services
  • Pharmacovigilance training for the client’s local sales force
  • System quality control checks to ensure full audit compliance