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