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• long and comprehensive experience in the pharmaceutical industry (Packaging & Labelling, Pharmacovigilance, Regulatory Affairs, Quality Assurance) • excellent scientific background and advanced understanding of medical terminology • familiar with various therapeutic areas including biotechs, vaccines, CNS, oncology, hematology • good knowledge of RA submission processes • very good understanding of clinical trials environment • knowledge of commercialization and business practices • quality and compliance-minded, sense of accuracy, strong team player, fast-learner Expertise • review of label texts/SMPC's/patient leaflets (French, Dutch, German, English) • thorough knowledge of artwork development processes and document management systems • pharmacovigilance and associated case management • trilingual FR/EN/NL + excellent knowledge of German


Past Experience

  • RA, QA & PV Coordinator
    August 2014 --- December 2015

  • Regulatory Affairs Assistant
    December 2013 --- February 2014

  • RA, QA, product complaints assistant
    June 2012 --- October 2012

  • Corporate Artworks Coordinator
    January 2012 --- July 2012

  • Pharmacovigilance and product complaints assistant
    January 2011 --- October 2011

  • Drug Safety and Medical Information Assistant
    January 1988 --- April 2010

  • Affiliate Labelling Coordinator Benelux
    October 1988 --- January 2009

  • Assistant to Responsible Pharmacist and Regulatory Affairs Managers
    January 1980 --- January 1988


Self Assessment :
Attention to detailAdaptabilityAnalytical thinkingCollaborationCreative thinkingFlexibilityInterest in knowledgeKindnessService orientedTrust


LinkedIn Assessment :
Pharmaceutical IndustryRegulatory affairsPharmacovigilanceArtworks/PackagingChange ControlDrug SafetySupply ChainVaccinesQuality AssurancePharmaceutics

Skills and Expertise

Self Assessment :
• review of label texts/SMPC's/patient leaflets (FrenchDutchGermanEnglish) Search literature on clinical trials Interact with physicians Use content management systemsAdverse event reportingAnswer, transfer and handle incoming calls as needed.Assess adverse reactionsAssess product quality issuesAssist with proceduresAttend seminars, courses and meetings within and outside the companyCommunicate effectively on different company levelsConduct literature searches.Creates a collaborative team environmentData codingData validationDevelop strong internal relationships with stakeholdersEnsure good clinical practice (GCP)Follow-up of Quality Management System (QMS) processesForecasting of packaging workloadInformed consent processInteract with regulatory stakeholdersLabeling compliance with local regulationsLiaise with professionals in other divisions of the company as requiredManage regulatory activitiesManuscript reviewNetworkObserve trends in dataOral presentationPrepare regulatory documents


  • Master’s Degree in Philologie Germanique from Université libre de Bruxelles in 1979

Training and Certification

  • Junior CRA training Certification


BrightOwl Assessment:
Self Assessment:
Full Proficiency
Full Proficiency
Professional Proficiency

Work Preferences

  • Work From Home:
    Yes, 1 Days
  • Work Regime:
    Permanent position :    80% FTE
    BrightOwl employee :    80% FTE
  • International:

Area / Region

Les Bons Villers, Belgium


Driving License
  • Yes