Exploitant - Pharmaceutical Establishment
Pharmacovigilance
PR and RPV support
- For the head pharmacist (PR) for managing the local pharmacovigilance system and liaising with the parent company
- For the pharmacovigilance reference person (RPV) for performing his/her duties
Initiating and improving your organization’s vigilance
- Drafting or reviewing your PSMF (global, local)
- Pharmacovigilance quality management system: drafting and reviewing procedures tailored to your organization and product portfolio
- Assistance with monitoring vigilance service providers, service provider qualification audits, etc.
Preparing teams for PV inspections
- Preparing PV experts and non-experts by theme
- Assistance with implementing and monitoring CAPAs
- Supporting improvement of the PV system
Tailormade in-company training courses (for various profiles within companies)
- Clinical trial vigilance
- Post-marketing pharmacovigilance
- Sales force training
Conducting audits and assessments
Consultancy on the regulation of post-marketing pharmacovigilance and clinical trials
Further information
Atessia will support you in your pharmacovigilance activities thanks to its extensive experience in both corporate and subsidiary organizations and through exclusive support for Head Pharmacists in both training and preparing inspections.