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I'm a trilingual Industrial Pharmacist looking at a new function in a Pharmaceutical Company in Regulatory Affairs, Quality Assurance, Pharmacovigilance, Medical Information (Responsablility Informaion & advertising), GMP & GDP auditor or GMP & GDP trainer

Experiences

Past Experience

  • Senior Regulatory Affairs Specialist

    April 2011 --- May 2013
    Marketing

  • Regulatory Affairs Consultant

    April 2010 --- July 2010
    Packaging

  • Regulatory Affairs Consultant

    October 2009 --- January 2010
    Packaging

  • Senior Regulatory Affairs Manager

    January 2000 --- November 2008
    Medical Devices

  • Quality Control responsible

    January 1998 --- September 1998
    Medical Devices

  • Pharmacien d'officine -

    December 1988 --- November 1997
    Propriétaire et gérante - officine ouverte au public Comptoir- ventes et conseils aux clients Préparations magistrales Gestion de stock-comptabilité-commandes Gestion du personnel

Personality

BrightOwl Assessment :
DependabilityKindnessCuriosityPerspectiveApproachabilityOptimismImpulse commandEfficiency
Self Assessment :
Interest in knowledgeAttention to detailEfficiencyAdaptability

Knowledge

BrightOwl Assessment :
dutchEnglishFrenchHealthcare industryMultilingualDrug Safety and PharmacovigilanceGeneral practice
Self Assessment :
Ethics submission and approval processRegistration of the productMarketing approvalHealthcare industryMultilingualdutchEnglishFrenchUnderstand levels of research evidenceGeneral practiceDrug development processRegulatory submissionsClinical trial designICH GCP guidelinesDrug Safety and PharmacovigilanceProject ManagementWriting Study Procedures and SOPsClinical trial audits and inspectionsMarketing Authorisation Application (MAA)Drug regulatory authoritiesUnderstanding of regulatory guidelines
LinkedIn Assessment :
Pharmaceutical IndustryRegulatory submissionsBiotechnologyMedical DevicesBiopharmaceuticalsLifesciencesCAPAGMPSOPGCPNutriments

Skills and Expertise

BrightOwl Assessment :
lifescienceSupport special projects requiring QA input.perform regulatory authority application and approvalsApprove the supply of formulated drug to outside clinicians who wish to conduct human studies
Self Assessment :
Assemble regulatory applicationsDevelop and maintain GCP/ICH compliant processes which control the quality of work and clinical trials Ensure subject safety and adverse event reporting to sponsor and IRB/IEC.perform regulatory authority application and approvalslifesciencePrepare required regulatory documentsMaintain and manage internal clinical trial files and documentsObtain grants for clinical researchInteract with regulatory agenciesPrepare regulatory documentation packets put together a succesful ethics committee applicationSupport special projects requiring QA input.Submit regulatory applications

Education

  • Numero d'autorisation FAGG pour Responsable Pharmacovigilance et Responsable information & publicité in from SGS in 2003
  • Pharmacien d'industrie in Stage chez Pfizer animal Health dans la validation du process de nettoyage des flacons pour vaccins from universite catholique de Louvain in 1999
  • Licence en sciences pharmaceutiques in from Université catholique de Louvain in 1985

Training and Certification

  • Certification des dispositifs medicaux in 2014 Training
  • Projetct management in 2014 Training
  • GCP in 2014 Certification

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl freelancer
    BrightOwl employee :    100% FTE
  • International:
    Yes

Area / Region

HEVILLERS

Others

Driving License
  • Yes

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