Pharmacovigilance and other vigilance
Pharmacovigilance
Atessia Vigilances handles the full or partial operational management of your pharmacovigilance system.
- Management of AEs from collection to submission: Documentation, Data entry, MEdDRA coding, Seriousness criteria, causality assessment, and submission to Health Authorities and / or partners
- Case management for special situations, including reports without AEs and invalid cases
- Follow-up of cases (FU, reminders to the reporter)
- EUDRAVIGILANCE case management (ICSR and / or MLM)
- Signal detection and signal assessment report writing
- Writing or review of Risk Management Plan (RMP) or PSUR
- Writing or review of the PSURs schedule, SOPs, SDEAs, andtechnical agreements
- Participation in 5-year renewal dossiers and variations for PV sections
These activities are conducted by pharmacists and doctors, with quality control performed by employees possessing over 15 years of experience in pharmacovigilance.
OTHER
VIGILANCE SERVICES
VIGILANCE SERVICES
Atessia Vigilances offers services in the fields of cosmetovigilance, materiovigilance, and nutrivigilance.
AnticipSanté vous propose ses services pour les secteurs de la cosmétovigilance, la matériovigilance, et la nutrivigilance.
- Documentation
- Data entry
- Submission to Health Authorities
- Sending to partners
- Local point of contact and relations with the manufacturer
