Raphael BOIRON

En résumé

Entreprises

• Novartis - Manager Pharmacovigilance and Clinical Quality Assurance

  RUEIL MALMAISON 2012 - maintenant

• Merck Serono - Senior Coordinator Global Drug Safety

  Lyon 2010 - 2012 Project 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 - 2010 Project 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

  Paris 2006 - 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-Billancourt 2005 - 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 - 2005 Development & 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

Formations

Pas de formation renseignée