Senior Vigilances and Regulatory Affairs Advisor
Doctor of Pharmacy
DE in Methodology of Therapeutic Risk Assessment (Paris)
Specializing in therapeutic risk assessment, Valérie worked in the pharmaceutical industry for twenty years in the vigilance and quality fields (Novartis, Pierre Fabre) and then for four years in a training organization for the health industries as a training consultant, senior expert in Vigilances and Regulatory Affairs.
Her skills include post-marketing pharmacovigilance and interventional clinical trials, quality management, consulting and training activities.
Her career has allowed her to work with structures covering a wide variety of types and sizes: parent companies, French subsidiaries, distributors, suppliers, hospitals and academic structures. She successively worked as a pharmacovigilant in a parent company (clinical trials and post-marketing) and then as a Quality Director in Vigilances and Regulatory Affairs.
She has also been a Deputy EU QPPV and participated in several pharmacovigilance (France and foreign) and operating establishment inspections.
Some examples of her roles:
- Supporting the head pharmacist in managing his local pharmacovigilance system and liaising with the parent company
- Accompanying the pharmacovigilance reference person (RPV) in performing his duties
- Launching and improving the organization’s alerts and quality management system; drafting or reviewing procedures and PSMFs (global, local)
- Preparing teams for inspections, assisting the implementation of CAPAs, audits and assessments.
Valérie joined ATESSIA in March 2020 as Senior Vigilances and Regulatory Affairs Advisor to develop a new Vigilance service, particularly on supporting the local pharmacovigilance system and liaising with the parent company, and supporting the pharmacovigilance reference person (RPV). She intervenes in all aspects of launching and improving the organization’s vigilance and quality management system.
She can also contribute her expertise to reviewing or drafting procedures or PSMFs (global/local). She supports preparations for inspections and the conduct of audits and assessments. She brings her pharmacovigilance expertise to the Atessia Intelligence Regulatory Monitoring Department.