PHARMACOVIGILANCE / VIGILANCE / COSMETOVIGILANCE
- EUQPPV + Deputy
- Local person for pharmacovigilance for CZ and SK
- Preparation of educational materials
- Regular monitoring of literature - both global and local
- Creation of a pharmacovigilance system according to the client's requests
- Preparation, submission of PSUR, PSUSA
- Preparation of Risk Management plans
- Preparation of sample contracts: Safety Agreement, Safety Data Exchange Agreement (SDEA)
- Preparation and elaboration of PSMF (Pharmacovigilance System Master File)
