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Summary

my ability to do medical literature Research work, compose Presentations and educate physicians got improved during my work experience at project farmaka. physicians were very pleased with the quality of the Presentations and after the visits/Presentations, the company was a standard of which the physicians looked forward to, in order to get periodical new updates. during my experience in quintiles (CRO), and due to the fact that i am a Physician, i collected a lot of new contacts with physicians/Hospitals/medical centra for the company, speed up the contracting time, and also performed on occasion feasibility studies which included kol contacts. my past experience with improvement projects and feedback systems, with as result improved Customer Service ratings and higher efficiency, could be a positive asset to your company. in Customer Service, i received a golden falcon reward to go above and beyond Customer Satisfaction and to improve Customer Satisfaction ratings from 63% to 96% in less than a year. since then, i am always looking for improvements and analysing data, even when it is not the core subject of my activity. leading teams, as proven in the past, poses no problems to me. it does not matter if it is a group of Customer Service people, a group of auditors, professionals or blue collar, i have done it all. teambuilding and trust lays on the foundation of this success, as well as shared ownership of ideas. my independent work drive, which is result driven, has proven to be an advantage to complete projects on time. time pressure is not experienced as something negative, but rather as an extra motivator. it would be an honour to me to be able to be a positive asset to your company. if you have any additional questions, please feel free to contact me, and i will try to answer you as prompt and as accurate as possible.

Experiences

Current Experience

  • Senior Clinical Safety Specialist

    Maastricht, Netherlands
    Since October 2015
    • review safety event
    • query sites
    • daily, weekly, monthly, quarterly reporting
    • work with multiple departments
    • matrix
    • trending
    • review sip, safety plan,...

     

    • REVIEW SAFETY EVENT
    • QUERY SITES
    • DAILY, WEEKLY, MONTHLY, QUARTERLY REPORTING
    • WORK WITH MULTIPLE DEPARTMENTS
    • MATRIX
    • TRENDING
    • REVIEW SIP, SAFETY PLAN,...

     

Past Experience

  • Clinical Trial Specialist I Waver, België

    July 2015 --- September 2015

  • Auditor

    September 2014 --- January 2015

    Auditing quality of materials. based on this, reviewing and Editing logistical and financial information which influences the pay outs to the producers of raw materials and delivery companies. reporting to the different unions.

  • Ass. Regulatory Affairs

    December 2012 --- July 2013

  • Coordinator

    July 2012 --- October 2012

  • Administrative Supervisor

    July 2010 --- July 2011
    supervising and coordinating role over import, export and acceptation departments. making sure targets are met, adjusting personel and workload.

  • Independent Scientific Investigator and physician educator

    October 2009 --- May 2010
    independent scientific Investigator. educating physicians about new developments in approaching and treating (Pharmaceutical and non-Pharmaceutical) of medical conditions, based on literature study and ebm). creating and doing Presentations.

  • Associate Site Start Up Lead

    October 2008 --- May 2009
    Associate site start up lead. Research projects got presented to belgium after which i had to find the adequate qualified number of investigators/physicians to participate in the Research project. feasibility. site identification, science)" rel="nofollow">Protocol presentation, cda and sif collection. liason to ssv-CRA’s and regional ssu leads

  • Occupational Medicine physician in training

    September 2007 --- October 2008

    doing preventive medical examination for: - pre-employment - periodical examinations during employment - re-employment after illness - students before their internships investigating safety of the work environment.

  • ER Tech

    April 2001 --- August 2004
    coordinating medical procedures, assisting with, and doing medical/Clinical examinations and interventions.

  • Medical Resident

    September 2001 --- April 2004
    MD residency: Internal medicine, er, Pediatrics, Surgery, obgyn, pulmonology, plastic Surgery, Psychiatry, occupational medicine.

  • Team Manager

    April 1993 --- April 2002
    - Planning inventories - making and providing inventory reports/results to third parties - Planning teams and managing workload - work division/organization - evaluation employees - Training employees ...

Personality

Self Assessment :
Attention to detailEfficiencyCritical thinkingCreative thinkingCoordinationAssertivenessApproachabilityStrivingAnalytical thinkingFlexibilityInnovative thinkingTrustStrategic thinkingService orientedProblem solvingProactivityOrganizationOptimismInterest in knowledgeIndependence

Knowledge

Self Assessment :
Compliance with regulationsCurrent Good Manufacturing Practice (CGMP)Study protocolsRegulatory affairs
LinkedIn Assessment :
Managed CareFDAmanagementBiopharmaceuticalsHematologyHealthcareMedical EducationFeasibility StudiesPresentation DevelopmentRegulatory affairsTrainingMedicineClinical trialsCROLeadershipClinical researchPharmacovigilanceBiotechnologyLifesciencesGCPPharmaceutical IndustryData AnalysisInternal medicinePediatricsImmunologyClinical DevelopmentSurgeryMedical DevicesoncologyNeurologyEpidemiologyICH-GCPInfectious diseasesClinical monitoringRegulatory submissionsDrug DevelopmentTherapeutic AreasNeuroscienceDermatologyPsychiatry

Skills and Expertise

Self Assessment :
Analyze dataConduct literature searchesContact potential subjectsControl dataCoordinate logisticsCreate SOPsDesign clinical presentationDistribute study documentsEnsure data consistencyEnsure data integrityEthics committee submissionsFeasibility analysis of proposed trial designGastrointestinal diseasesGenerate regulatory submissions Indentify clinicians to conduct clinical trialsIdentify investigatorsInformed consent processInterpret analytical resultsCollect patient forms and questionnairesCollaborate with project team Create SOPs Interact with nurses Interact with physicians Interpret data Report dataAdjust processes and methodsAdminister logisticsAnalyze dataArchive documentationArchive study documentsAttend seminarsAttend steering committeeCoachCoach staffCollaborate with medical teamPrepare regulatory documents Control dataCoordinate projectsRegulatory documentationRegulatory submissions

Education

  • Master's degree in Health/Health Care Administration/Management from St. Joseph's College (ME) in 2008
  • Doctor of Medicine (M.D.) in Medicine from Saint Matthews School of Medicine in 2004
  • Bachelor's degree in Pre-Medicine/Pre-Medical Studies from Excelsior College in 1996
  • A1 in Sociale Readaptatiewetenschappen from Hogeschool Hoger Instituut voor Readaptatiewetenschappen Leuven in 1987

Languages

BrightOwl Assessment:
Self Assessment:
English
Native
Dutch
Native
French
Professional Proficiency

Work Preferences

  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    FTE (80%-100%)% FTE
  • International:
    Yes

Area / Region

Oud-Heverlee, Belgium

Others

Driving License
  • Yes

Other Candidates in Belgium

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