EUQPPV/RPV
Atessia Vigilances's team comprises qualified professionals capable of taking on the role of EuQPPV and / or de RPV, and of developing, maintaining and restructuring your European and / or local pharmacovigilance system in compliance with regulatory requirements (GVP and BPPV).
- Write and update local or European PSMF
- Create and / or maintain PV system
- Serve as the point of contact for health authorities with 24/7 availability
- Supervise all activities related to the detection, evaluation, interpretation and communication of vigilance information
- Write or supervise the drafting and updating of vigilance documents.
- Monitor drug safety profile
- Implement risk minimization measures and assess their effectiveness
- Provide training to the team in Pharmacovigilance
- Continuous training on changes in legislation and guidelines
- Provide support for inspections and audits, including participation
- Oversee the reconciliation of complaints and medical information
