At Billev Pharma ApS we have a team of highly qualified pharmacovigilance (PV) employees with expertise in all aspects of pharmacovigilance. We offer services both within human and veterinary pharmacovigilance and provide flexibility whether a short-term or long-term solution is needed.  

We offer services within:

  • QPPV and 24/7 availability for human and veterinary pharmacovigilance
  • PV QMS System
  • Pharmacovigilance System Master File (preparation & maintenance)
  • Risk Management Plan
  • Handling of adverse drug reactions (collection, processing, distribution & reporting)
  • Literature screening (Worldwide, MLM & local)
  • Signal management
  • Periodic Safety Update Reports
  • Eudravigilance – reporting of adverse drug reactions
  • XEVMPD – inserts and maintenance of product information
  • Pharmacovigilance agreements / safety data exchange agreements
  • Pharmacovigilance audits
  • Support in connection with pharmacovigilance inspections