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.
Senior Clinical Safety SpecialistMaastricht, Netherlands
Since October 2015
- review safety event
- query sites
- daily, weekly, monthly, quarterly reporting
- work with multiple departments
- review sip, safety plan,...
- REVIEW SAFETY EVENT
- QUERY SITES
- DAILY, WEEKLY, MONTHLY, QUARTERLY REPORTING
- WORK WITH MULTIPLE DEPARTMENTS
- REVIEW SIP, SAFETY PLAN,...
Clinical Trial Specialist I Waver, BelgiëJuly 2015 --- September 2015
Ass. Regulatory AffairsDecember 2012 --- July 2013
CoordinatorJuly 2012 --- October 2012
Administrative SupervisorJuly 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 educatorOctober 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 LeadOctober 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 trainingSeptember 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 TechApril 2001 --- August 2004
coordinating medical procedures, assisting with, and doing medical/Clinical examinations and interventions.
Attention to detailEfficiencyCritical thinkingCreative thinkingCoordinationAssertivenessApproachabilityStrivingAnalytical thinkingFlexibilityInnovative thinkingTrustStrategic thinkingService orientedProblem solvingProactivityOrganizationOptimismInterest in knowledgeIndependence
Compliance with regulationsCurrent Good Manufacturing Practice (CGMP)Study protocolsRegulatory affairs
Skills and Expertise
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
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