Mes compétences :
Santé
Management
Industrie pharmaceutique
Entreprises
Mylan
- Drug safety officer
SAINT PRIEST Cedex2009 - maintenantOngoing Safety Monitoring, Review of adverse event reports, Permanent screening of literature for published safety data, preparation of PSUR and other regulatory documents, Signal evaluation for all Marketed drugs, Performs database searches following safety questions by the affiliates and replies to the questions accordingly.
Merck
- Drug safety officer
Lyon2007 - 2009Ongoing Safety Monitoring, Review of adverse event reports, Permanent screening of literature for published safety data, preparation of PSUR and other regulatory documents, Signal evaluation for all Marketed drugs, Performs database searches following safety questions by the affiliates and replies to the questions accordingly, Reviewing clinical trials. Redaction of Local SOP. Reporting for SUSAR to health authority.
R&O Concepts
- Clinical trial manager
2005 - 2005Work Experience of 7 months. Veterianirien Drug
Redaction of protocol & Management of trial.
Contact with Regulatory agency.
Management and redaction of Regulatory file.
