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Experiences

Current Experience

  • Free Lance Consultant


    Since October 2009

    independant Consultant : operational aspects of Pharmacovigilance activities. certified for eudravigilance icsrs reporting and xevmpd. glaxosmithkline biologicals, boehringer-ingelheim, thrombogenics, novo-nordisk besins,...misc. cros

    Independant consultant : operational aspects of pharmacovigilance activities. Certified for Eudravigilance ICSRs reporting and xEVMPD. GlaxoSmithKline Biologicals, Boehringer-Ingelheim, Thrombogenics, Novo-Nordisk Besins,...Misc. CROs

Past Experience

  • Head case management group - Biologicals Clinical Safety & Pharmacovigilance

    August 2007 --- September 2009
    staff of 30 people : overall responsibility of case management activities (pre and post registration) including Data entry, data reconciliation, resource Forecasting and Outsourcing, Compliance with applicable laws and regulations (emea, FDA, ich, gcp) Quality Assurance, safety data exchange agreements, active participations to inspections & responses to findings (FDA, bha) , review of sops and establishment of working documents,…

  • Manager case management group (post marketing case handling)- Biologicals Clinical Safety & Pharmaco

    September 2006 --- July 2007
    9/2006 - 07/2007: manager case management group (post Marketing case handling)- biologicals Clinical safety & Pharmacovigilance management of post Marketing Data entry group (5 people) including all Data entry activities (spontaneous cases, post Marketing surveillance, literature), data base searches (periodic reports, product complaints, ad hoc queries), expedited reporting (e2b), resource Forecasting, guidance documents, participation and responses to audits.

  • Senior clinical safety associate - Biologicals Clinical Safety & Pharmacovigilance )

    April 2003 --- August 2006
    Data entry of post Marketing and Clinical Trial cases, data base searches, expedited reporting, input to case management guidance documents.

  • Clinical safety associate - Biologicals Clinical Safety & Pharmacovigilance (

    February 1997 --- March 2003
    Data entry of post Marketing and Clinical Trial cases, data base searches, expedited reporting.

Knowledge

LinkedIn Assessment :
PharmacovigilanceClinical trialsFDACRODrug SafetySOPICH-GCPGCPPharmaceutical IndustryRegulatory submissionsLife SciencesRegulatory affairsSOPClinical DevelopmentMedical writingClinical research

Area / Region

Piétrain, Belgium

Others

Driving License
  • Yes

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