BOULOGNE-BILLANCOURT
I am an Associate Director with more than 7 years’ experience in pharmacovigilance pre- and post-authorization (incl. compassionate use/named patient programs).
I am acting as a project manager on several pharmacovigilance pre-authorization projects (from phase 1 to 3 worldwide clinical trials) and post-authorization projects (both for European centralized and national approved products) to set-up and maintain pharmacovigilance systems, in line with applicable regulations. I am also acting as Deputy EU QPPV.
Working in a consulting company gave me the opportunity to develop an extensive experience in terms of type of products, indications and geographical areas.
I am also involved in “pre-project” activities, including contact with prospects to understand their needs, pharmacovigilance proposals writing and follow-up, pharmacovigilance agreements preparation.
Finally, I’m coordinating some quality assurance activities, in cooperation with the quality assurance department, such as organising the preparation, review, update, publication of relevant procedures, review and follow non-conformities or CAPA plan on a regular basis, prepare audit or inspections.
Key skills:
• Set-up of pharmacovigilance systems (incl. interactions with all stakeholders and set-up of partnerships)
• Management/coordination of pharmacovigilance projects as project manager (leading a project team)
• Case management
• Pharmacovigilance deliverables writing and submission (DSUR, PSUR, PSMF, SMP…)
• Vigilance safety database administration/set-up/maintenance
• EudraVigilance system (company/users registration, case reporting via EVWEB and product registration in the XEVMPD)
• Standard Operating Procedures writing and maintenance
• Internal/external staff training
• Good communication/interactions skills
Mes compétences :
Essais cliniques
Gestion de projet
Pharmacovigilance
Affaires réglementaires
XEVMPD
EudraVigilance
BPC/GCP
BPV/GVP
