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Summary

10 years experience Monitoring in house and on site Phases 2, 3, 4 Oncology, Diabetology, Cardiology, Parkinson, HPV, Alzheimer 1 year experience Study Start-Up - Submissions Phase 1, Cardiology and Diabetology

Experiences

Current Experience

  • Regulatory Affairs Coordinator
    Since June 2014
    - Assist the responsible of the Regulatory Affairs Department in the statutory follow-up of the requests of License of Launch on market of the specialities of the company - Prepare all the documents necessary for the renewal of the Licenses of Launch on market ( AMM)

Past Experience

  • Medical Officer
    October 2013 --- February 2014

  • Junior CRA - ESDS (Clinical Research)
    May 2012 --- March 2013
    - Project support of phase I Clinical Pharmacology / experimental medicine / novel biologics studies - Support regulatory submissions - Study initiation - Study conduct and observational monitoring - Clinical Data monitoring

  • Quality and Compliance Coordinator
    January 2011 --- January 2012
    -Provide full support for ensuring global quality and compliance Pharmacovigilance activities. -Provide GCSP Management with clear visibility of overall progress of projects and action plans, highlighting potential issues for resolution. -Collaborate with GCSP QA to guarantee compliance of the global Pharmacovigilance quality system with the corporate quality standards and to identify (recurrent) audit/inspection findings -Participate actively to the resolution of CAPAs -Provide data for the monthly compliance reports on safety activities -Escalate relevant Quality and/or Compliance issues when required.

  • Clinical Safety Associate
    May 2011 --- September 2011
    - Triaging, collecting, monitoring, processing, and distributing the adverse event reports (serious and non-serious Adverse Event(s) ) to sponsor or regulatory authorities and project team within specified timelines - Generate queries related to serious and non-serious Adverse Event and follow up until resolution. - Perform all safety database required functions, e.g data entry, narrative preparation, dictionary management etc, until completion of the case, and retrieve all customized and other regulatory reports. - Perform comparative review of Clinical and Safety database and reconciliation of all adverse events. - Perform other safety-related tasks that may be required for specific protocol or due to change in regulatory requirements.

  • Clinical Trials Assistant and CRA
    May 2000 --- October 2010
    - Support project team in all administrative activities. - Generate and maintain databases for appropriate administration. - Prepare and keep the master file and study centre files including all GCP-related documents. - Administer all study and related documents before and during the course of the study (i.e. drug accounting documents, correspondence, monitoring reports, contact reports, and other organizational papers). - Support Project Manager and CRAs in all relevant activities. - Transmit all CRFs after of the quality control procedures and registration in the CRF retrieval database to data management department for data entry and quality control. - Assist Project Manager in preparing project status reports for clients. - Submit final monitoring trip reports to the Regulatory Department for filing. - Assist Project Manager as required to ensure the successful completion of the study. - Assistance/support for the logistics aspects. - Document management and administrative support.

  • HR Assistant
    June 1997 --- May 1998

Personality

Self Assessment :
AdaptabilityAttention to detailCollaborationCommunicativeCoordinationCuriosityEfficiencyFlexibilityIndependenceOrganizationProactivityResult OrientedResponsibility

Knowledge

LinkedIn Assessment :
Clinical trialsClinical researchRegulatory submissionsClinical monitoringCompliancePatient SafetyMedical TerminologyProtocol AnalysisTMFSpectrumInformOceanSAPAdverse Event ReportingAdverse Events (AE)Safety RegulationsProcess SafetyClinical Site MonitoringMedDRAPharmacovigilancePharmacokineticsEDC entryGCPsICH-GCPPhase IPhase 3oncologyDiabetesAlzheimer's diseaseParkinsonHIVDrug AccountabilityIndependant monitoringFirstDocDocumentumERPPhase 2CTMSMonitoring visitsClosing visits

Education

  • in Nursing Education from HEPN in 0

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency
Dutch
Elementary Proficiency

Work Preferences

  • Notice Period:
    1 week
  • Locations I am interested in:
    Belgium
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position
    BrightOwl freelancer :    40 Hours per week
    BrightOwl employee
  • International:
    Yes

Area / Region

Belgium

Others

Driving License
  • No