Mes compétences :
Biologie
Communication
Industrie pharmaceutique
Pharmacovigilance
Safety
Veille
Entreprises
Novartis
- Manager Pharmacovigilance and Clinical Quality Assurance
RUEIL MALMAISON 2012 - maintenant
Merck Serono
- Senior Coordinator Global Drug Safety
Lyon2010 - 2012Project Management
- Train and coordinate vendors activity and provide expertise support (medical & conventions)
- Train the LDSO to case processing activities
- ARISg trainer for new comers (Headquarter & Affiliates with ARISg access)
- Provide support to System Group in case of database system changes as appropriate
Case Management
- Case Initiation and Triage (seriousness, causality, adverse event verbatim) of all ICSRs initiated in the GDS database for both investigational and marketed products
- Send queries to LDSO for discrepancies clarifications or medical assessment
- Case Processing: write narrative case summary, code patients reactions, diseases, drugs and indications
- Quality Control: make sure that all processed cases are checked against source data (QC) in quality and time
- Case Evaluation and approval: perform assessment for all non-serious ICSRs and write PV comment
- Exchange case documentation with partners (CROs, GCO, LDSOs, and license partners) and track these exchanges
Jonhson&Jonhson
- Local Drug Safety Scientist & PV Compliance
2007 - 2010Project management
- Responsible for local compliance (tracking of late cases, metrics, establish and monitor CAPA)
- Responsible for drug safety training of new employees (face to face training) and annual certification for all affiliate employees via Training Manager tool
- Writing and updating the local procedures according to Headquarter and European SOPs
- Reconciliation between PV & call center
- Project management: publicity brochure (project guideline writing, invitation to tender, project team management, schedule meetings with agencies and all staff involved in the project)
Case management & Aggregate reports
- Reception of Post Marketing and clinical trials cases: take calls for PM cases and SAE form check desk and review for CT cases
- Case processing (data entry, codification, narrative writing, local assessment and submission)
- Submission tracking and reporting of both French and international cases to the French Authority
- Local literature review
- Responsible for submission of ASR & SUSAR LL, planning and tracking of all aggregate reports
- Support for PSUR French synthesis & compassionate use safety reports
Audits & Inspections
- Regulatory monitoring
- Preparation of the pre-inspection and pre-audit documentation
- Active participation to audit & inspection interviews
- Participate to answer to audit / inspection reports: propose and monitor the CAPA
Sanofi Aventis
- Clinical Area Suppot Officer
Paris2006 - 2007- Responsible with the GSO of the Safety of three international projects (CNS area)
- SAE reconciliation, documentation and validation before database lock (SAE coding, queries to PV affiliates)
- Safety reports writing (ASR, PSS, Safety section of the IB and Clinical study reports)
- Review of clinical documents and reports (CRF, Monitoring Plan, protocol)
- Clinical data reviewing and Safety status for CTT meeting and Data Review Report
- Safety presentation during investigator meeting (CRA training)
- Signal detection
Roche
- Chargé de pharmacovigilance
Boulogne-Billancourt2005 - 2006- Case processing: data entry and narrative writing for spontaneous notifications
- Case quality control
- Participation to drug safety training of internal staff
- Project management of a drug safety brochure for health care professional
Généthon R&D
- Trainee Research Associate in Biotechnology
2005 - 2005Development & Production of viral vector by gene therapy and process optimisation - European project, context of orphan disease treatment
Technical experience: Cells culture in flasks and bioreactors with microspheres, optimisation process by realisation of an optimum medium culture for cells growth & viral production, FACS, microscopy, data analysis and memory writing
