BrightOwl Loader Loading

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) - 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 science)" rel="nofollow">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 0000

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

Similar Candidates

Other Candidates in Belgium

Other similar Candidates in this location (country / city)

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like