Francine GALIBERT

En résumé

Entreprises

• United Biosource Corporation - Senior Safety Scientist

  2013 - maintenant : Senior Safety Scientist Supporting all functions in pharmacovigilance Department (client interface):
  * Assist with preparation of adverse event reporting plan at project start-up and database configuration needs (Argus or baseCon) ;
  * Process and evaluate AE reports and perform review/quality check of source documents ;
  * Assist in reconciliation between clinical and safety databases ;
  * Support preparation and quality control of aggregate reports ;
  * Train personnel and lead training session
  * Monitor compliance metrics ;

• Merck Serono - Responsible Case Processing

  Lyon 2007 - 2013 Indication: Neuro / AutoImmune Diseases, Fertility, Endocrinology, oncology
  * Ensure ICSR from PM and CT sources are correctly processed in safety database (ARISg V5): triage, FU queries, data-entry, coding and narrative writing, QC, assessment
  * Liaise with stakeholders (Medical Evaluation, Clinical Monitoring, Data management, Affiliates) to ensure appropriate data processing, resolve case issues, participate to reconciliation.
  * Develop/maintain Quality Documents and training material (WI, Related documents, data processing guideline)
  * Provide training on safety database, data processing conventions, WI.
  * Participate to System Validation and database improvement
  * Perform CAPA management
  * Set up a Data Entry Facility site in Brazil. ;
  * Coordinate CRO's activities where ICSRs data processing is outsourced (training, transfer of activities, monitoring, process clarification for improvement and issue solving, writing change of order)
  * Introduce new activities to case processing team (narrative writing, triage, SAE check desk function) ;

• Berlex Pharmaceuticals - Clinical Coordinator

  2003 - 2005 Indication: Crohn's Disease
  * Creation of an SAE database (Access) for phase II and III studies for clinical staff to track and follow-up all the SAEs during the trials and to facilitate reconciliation.
  * Implementation of an SAE procedure (routing and archiving processes, forms to design, working closely with drug Safety) within the clinical department.
  * Review of site start-up and regulatory documents to allow site initiation visits and drug shipments (IRB revised ICF, accuracy of 1572, financial disclosure, IRB approval, site agreement...) by working closely with the sites and with different departments (Legal, Regulatory, Drug Delivery).
  * Work on final datalock of a phase II study (review data listing, queries generated, follow-up with the sites) and participation in the archiving of the study by doing internal file audit and recovering missing items.
  * Development of a study site-specific payment spreadsheet for the CRAs that determines instantly and exactly what is owed to the sites at any time during the study. ;

• Immunex Corp. - Clinical Assistant

  1999 - 2003 Indications: Rheumatoid Arthritis, Ankylosing Spondylitis, CHF, Asthma.
  * Provide Project support on multiple studies including the collection and review of regulatory documents of US, Canada and European sites at start-up and for audit for final archiving.
  * Establish the process of drug shipment and site inventory by working with an IVRS and drug delivery system (SAP and CDSS), foreseeing and correcting any delivery troubles to avoid drug interruption by a daily maintenance and a close relationship with Drug Shipment.
  * Define the working specifications for an IVRS and the user manuals with the project leader and vendor, tested the system and ensured maintenance by working closely with the vendor.
  * Conduct Data clean-up to ensure on-time database lock. ;
  * Track and reconcile SAE - AE database in a 900 patients CHF clinical study. ;
  * Design Study startup documents. ;

• FDM Pharma - Regional CRA

  1994 - 1996 Indications: Oncology, Impotence and Pregnancy
  * Monitor phase II through phase IV clinical studies from the initiation to the close-out visit, Recruit investigators, Assure adherence with GCP. ;

• ITEM - Office-based CRA

  1992 - 1994 Indications: Depression, Hypertension, HIV
  * Also organize investigator meeting, Perform data clean-up and data coding, Ensure the SAE follow-up. ;

Formations

• INSA De Lyon

  Villeurbanne 1991 - 1991 Master
  
  Master in Computer science

• Centre Universitaire Des Sciences Et Techniques

  Clermont Ferrand 1987 - 1990 Master
  
  Master in Biological Engineering - Centre Universitaire des Sciences &Techniques, Clermont-Ferrand, France (training 6 months in Sandoz (Basel, Switzerland) on production and secretion of Interleukin-3 by transformed E. Coli

• IUT De Clermont

  Clermont Ferrand 1985 - 1987 Diplome Universitaire Technologique
  
  Technical Diploma (BS) in Biological and Biochemical Analysis - I.U.T., Clermont-Ferrand, France (training at France Plats Cuisines (Sablé-sur-Sarthe, France) on microbiological quality control

Réseau

Pas de contact professionnel