Mes compétences :
Pharmacovigilance
Quality Control
ARISg
Adverse events
SAP
Microsoft Word
Microsoft PowerPoint
Microsoft Excel
MedDRA
Data Entry
Clinical Trials
Business Objects
Adverse Event Reporting System
Entreprises
Sanofi Pasteur
- Coordinator en Pharmacovigilance
Lyon2014 - 2014* Worked as PV Quality and Compliance Officer
* Managed manufacturing investigations ;
* Managed product technical complaints (PTC) (establishment of potential link with adverse
events)
* Wrote pharmacovigilance part of annual product review (APR) ;
* Performed quality control of safety reports (PBRER, RMP, SAR...)
* Worked in outsourcing of clinical trial cases ;
* Wrote working documents for the CRO relative to the case processing in PV database (Oracle
AERS) for each study
* Wrote instructions regarding the unblinding processes for each study ;
* Prepared and presented trainings concerning data entry coding rules and case management
specificities
* Wrote contractual documents and prepared invoices ;
* Performed quality control of PV cases ;
* Answered to CRO questions concerning codage in database
VIGIPHARM
- Chargée de vigilance sanitaire
Montpellier2012 - 2013* Managed cases of pharmacovigilance in Safety Easy and ARISg PV databases: reception,
validation, MedDra codage, french imputability, company causality, follow-up telephone calls,
reporting to health authority.
* Wrote all sections of periodic safety reports (PSUR, PBRER, AOC, Addendum) ;
* Medical information: answered to patient or health care professional questions ;
* Performed literature screening ;
* Translated PV cases (French to English)
* Participated to audit and inspections
Sanofi Pasteur MSD
- Internship in Pharmacovigilance
2012 - 2012* Entered cases in PV database (ARISg) ;
* Performed medical review and wrote medical assessment ;
* Performed follow-up telephone calls
