Pharmacovigilance (PV)

Pharmacovigilance (PV)

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:

  • Fast system implementation
  • PV systems adjusted to project size
  • Customized PV cooperation models
  • Complete visibility, effective oversight – PV inspection readiness

PV System fundamentals:

  • EMA/FDA regulations
  • GVP
  • Project specific
  • Safety Plans
  • Local specific regulations
  • Study protocols, RMPs
  • Sponsor SOPs Customized technology solutions

Service Quality

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):

  • PV system set-up timelines
  • Case processing timelines, compliance
  • Safety submissions timelines, compliance – Documentation quality

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Trial Execution Technology

A unique clinical research center in Europe with its own operating room