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Experiences

Past Experience

  • Medical information/RA/QA Anderlecht, Belgium

    January 2013 --- February 2016

    Quality Assurance Coordinator

    • checking registration of all audits
    • checking capa database versions, identification of observed anomalies and implementing corrections
    • data archiving in omnirimsystems
    • archiving of biopharm, market Diabetes and Sales contracts in Contract Management system (cms)
    • reply to complaint letters and their recording in e-deal system

     

    regulatoryaffairs

    • compiling 2 medical need programs (mnp) files according to current legislation and guidelines
    • submission of mnp files to Ethics committee and Health authorities
    • handle questions/issues from Health authorities
    • organise the inclusion of patients in the mnp
    • regulatory update of smpc, abridged smpc and leaflet of several medicinal products about Diabetes, growth hormone and hormone replacement therapy (hrt)
    • reviewing the internal procedure of «compassionate use» and «medical need program»
    • monitoring of local safety literature in order to detect any Adverse Events (ae) and other safety information associated to novo nordisk products
    • informing Pharmacovigilance unit when a safety case is reportable and sending an adverse event form to the reporter

     

    medical Advisor / medical information

    • preparing medical material for internal/external customers
    • preparing educational slide sets on specific topics related to Diabetes product portfolio and growth disorder
    • answering questions from hcp (specialists and general practitioner)
    • answering questions related to Reimbursement criteria of novo nordisk products
    • Training of medical delegates about growth disorder, growth hormone product and devices
    • updating of novonordisk.be website
    • bibliographic search of information in the parent company's database and pubmed to answer our customers
    • reply and writing the answers of customers'faqs
    • redaction of Training tools for Customer Service
    • Training of Customer Service staff

  • QC Supervisor Wavre, Belgium

    August 2014 --- December 2015
    • ensuring day to day supervision of the operational team for one or two projects and/or technology. fosters motivation and development of staff through adequate Communication and Coaching (release and stability)
    • participation in adequate Validation/Qualification (design, Strategy and follow-up of execution) of (in-process) Analytical methods using appropriate Statistical tools, in line with projects timelines
    • organization and animation of project monitoring meetings: Planning, coordination of the various activities of the project, identification and Treatment of blocking points
    • participation in the Analytical methods transfer from ard to other Quality Control departments
    • writing technical documents (Validation protocols, Change Control request and Validation reports)
    • translate Validation protocols into experimental plans and communicate them to operational teams in charge of the Analytical methods
    • identify and escalade to direct management any issue impacting supply
    • assisting the qc product Coordinator by providing all analytical relevant information generated in my team
    • participation in deviations, capa management and investigations
    • guaranteeing the Compliance to cGMP/qa rules (SOP, Documentation, method Validation)
    • ensuring contact and collaboration with qa, qcss, ra, production and tlcm for the implementation of reagent changes
    • gathering information requested by ra

Personality

BrightOwl Assessment :
Anger commandReaction to stressSociabilityCuriosityCreative thinkingTrustAuthenticityCharmOrganizationAttention to detailDiligenceEfficiencySelf-discipline
Self Assessment :
AdaptabilityAnalytical thinkingAttention to detailCommunicativeResult OrientedProblem solvingOrganization

Knowledge

BrightOwl Assessment :
ValidationVirologyCell CultureData ManagementQuality Control (QC)Project ManagementBiotechnologyGood Manufacturing Practice (GMP)Good Laboratory Practice (GLP)Regulatory guidelines
Self Assessment :
Biochemistry Cell biology DiabetesWriting Study Procedures and SOPsInformed Consent DocumentsWestern BlottingVirologyVerificationVascular surgeryValidationVaccinesUrologyUnderstanding of regulatory guidelinesUnderstand levels of research evidenceUnderstand how results translate to practiceTranslationTransfectionTraining R&DAllergy and immunologyAnalysisAntibodiesBiochemistryBacteriologyBiologyBiotechnologyCancerCardiologyCardiovascular diseasesBiomedical SciencesCell CultureCell SignalingcGMPChange ControlCompliance with regulationsDatabasesDermatologyDiagnosticsDNA extractionDrug substancesElectrocardiogram (ECG)ElectrophoresisELISAEndocrinologyEnglish

Skills and Expertise

BrightOwl Assessment :
Collect dataEncode dataAnalyze dataWrite documentsFollow up projects
Self Assessment :
Analyze data Assure medical quality Control data Interact with physicians Interpret dataWritten presentationWork with coordination and data management teamsWork under specific instructionsVerify dataValidate dataUse western blotting techniqueUnderstand protocolsTranslate strategy into operational plansTrain StaffSubmit regulatory applicationsReport serious adverse events (SAE)Report non-compliance incidentsReport Key Performance Indicators (KPI's)Regulatory submissionsRegulatory documentationRead medical literature to maintain current awareness and knowledgeRead medical literatureQuality control processproject managementPlan experimentslifescienceInterpret scientific dataInterpret research resultsInterpret dataInteract with statisticiansInteract with regulatory stakeholdersInteract with physiciansEnsure data integrityEnsure data consistencyDesign protocolData verificationData validationData miningDefine market needsDesign case record form (CRF)Data codingCoordinationCoordinate projectsCommunicationCompile informationCollect dataCell cultureAssure medical qualityAssess quality process issuesArchive documentation Write protocols

Education

  • Master in Biomedical Sciences from Faculty of Medicine, University of Strasbourg, France in 2011
  • Doctor in General Medicine from Faculty of Medicine – University UMMTO, Algeria in 2009

Training and Certification

  • Soft Skills in Biotechnology in 2012 Certification

Languages

BrightOwl Assessment:
Arabic
Native
French
Full Proficiency
English
Professional Proficiency
Self Assessment:
French
Full Proficiency
English
Professional Proficiency
Arabic
Full Proficiency

Work Preferences

  • Positions I am interested in:
    Scientific Writer Scientific Officer Scientific consultant scientific collaborator Scientific Associate Scientific Advisor Reviewer Regulatory Affairs Officer Regulatory Affairs Consultant Regulatory Affairs Associate Regulatory Affairs Assistant QA Officer QA Consultant Project Manager Project Assistant Pharmacovigilance Officer Pharmacovigilance Assistant Medical Writer Medical Science Liaison (MSL) Medical Officer Medical doctor Medical Data Coordinator Medical Affairs Associate Medical Advisor Junior Consultant Drug Safety Officer Data Reviewer Clinical Trial Coordinator (CTC) Clinical Trial Assistant (CTA) Clinical Safety Associate Clinical Research Physician Clinical Research Coordinator Clinical Research Associate (CRA) Clinical Data Reviewer Biomedical Scientist
  • Locations I am interested in:
  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl freelancer
    BrightOwl employee
  • International:
    No

Area / Region

Brussels, Belgium

Others

Driving License
  • Yes

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