Alexandra Jobert

Direction of Research and Innovation. Management of the Research Vigilance Unit. Support to the project team in choosing the methodology for projects with safety or efficacy criteria. Writing and implementation of SOPs (maintenance of the internal QMS and participation in process improvement). Writing, quality control, and validation of safety reports (ASR, DSUR). Preparation, writing, and validation of clinical trial protocols (safety section), pharmacovigilance documents, and reports. Constant communication with the software publisher for vigilance (administration, validation of the vigilance database, evolution, testing, and specifications). Training of personnel in pharmacovigilance (especially adverse event collection and monitoring), as well as in vigilance software (personalized training). Preparation, writing, and validation of clinical trial protocols (especially the safety section), pharmacovigilance documents, and reports. Management (data entry, analysis, and validation) of vigilance cases from clinical trials sponsored by Nantes University Hospital. Database reconciliation (vigilance vs. clinical, eCRF).