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Summary

during my Training in Public HealthBiostatistics/Epidemiology (master’s degree – ulb), i’ve worked as Interim midwife (bachelor’s degree of midwifery – helb), in different Hospitals in brussels. i gained some experience in Biostatistics as Student support; i had to help students to understand the courses or the Statistical Analysis program epi-info; the principal challenge was to re-explain the courses in a different way to help students to understand the theory, and be able to apply this one. i also gained some experience in safety, as Clinical safety Administrator in the international division for sjm, a Medical Device company. i’m flexible, motivated, dynamic worker, methodical and team spirited with good organization skills. i can easily adapt to new situations.

Experiences

Current Experience

  • Senior Safety Specialist

    Zaventem, Belgium
    Since December 2017
    eCRF

    Became Sr. Safety Specialist in December 2017.
    Started as “St Jude Medical” employee (2016) – company was acquired by “Abbott”.
    (Medical Device Safety) Adverse Events and Potential Complaints reporting.
    Working in the international division for the Clinical Department. Main challenge: timelines.

    Approach & main achievements
    • Reviewing and querying (as applicable/necessary) assigned Case Report Form (CRF) within timelines and according to the Clinical Investigation Plan (CIP).
    • Assessment of adverse event reports and analysis for clinical, regulatory and complaint handling submissions, in compliance with worldwide reporting requirement. Submission of potential complaints and MEDDEV/AE listings as per applicable legislation.
    • Data reconciliation.
    • Project team meetings.
    • Collaboration with the CRA to ensure comprehensive information is available for full review and reporting.
    • CRF discrepancies/requests management.
    • Safety Plan preparation.
    • Contribution to Safety section of Protocol design and Quality by Design meetings participation.
    • Contribution to Safety section of submissions, reports, clinical summaries (as applicable/needed).
    • Developing and facilitating safety training including creation of materials.
    • Drafting AE narratives as required.
    • Contribution with revision or writing of SOP/Instructions/Procedures and changes to support clinical department.
    • Clinical Event Committee management (CEC charter, plan meetings, ...)

     

    Technical environment & methodologies
    • Oracle Clinical Database
    • EPIQ database (for complaints)
    • Excel (MEDDEV).
    • Use of MedDRA (Medical Dictionary for Regulatory Activities)
    • Organize the day/week.
    • Reach objectives in given timelines.
    • Stay up-to-date regarding the knowledge of global safety regulations, principles of device development and safety assessment of devices both on the market and in clinical development.

Past Experience

  • Safety Specialist II Zaventem, Belgium

    January 2016 --- November 2017
    eCRF

  • Pharmacovigilance Manager Brussels, Belgium

    September 2015 --- December 2015
    eCRF

  • Clinical Safety Administrator Zaventem, Belgium

    July 2014 --- August 2015
    eCRF

  • Interim midwife

    August 2011 --- June 2014
    Hospitals

  • Customer Advisor

    January 2014 --- March 2014
    dutch

  • Student Support in Biostatistics

    July 2012 --- August 2013
    Public Health

  • Interim midwife

    August 2011 --- November 2012
    Interim

Personality

Self Assessment :
AdaptabilitySelf-disciplineOrganizationInterest in knowledgeEfficiencyCuriosityCollaborationAuthenticityApproachabilityAttention to detailSociability

Knowledge

LinkedIn Assessment :
Neonatal NursingNursing CareStataEpi InfoRSASSPSSMicrosoft WordMicrosoft ExcelAccess DatabasePowerPointOracle ClinicalClinical researchRegulatory requirementICH-GCPMedical DevicesClinical trialsRegulatory submissionsClinical SafetyBiostatisticsEpidemiologyMidwiferyMother-child CareMicrosoft OutlookSOP'sISO 14155

Skills and Expertise

Self Assessment :
Analyze data Control data Interact with nurses Interact with physicians Interpret data Report data Search literature on clinical trialsAdverse event reportingAssess adverse reactionsAssess subject safetyClinical data collectionComplete case report form (CRF)Data analysisData codingData entryData verificationDetermine statistical analysis Develop clinical hypothesesDevelop clinical trial protocolsEnsure good clinical practice (GCP)Ethics committee submissionsSerious Adverse Event (SAE) ReconciliationStatistical analysisWork under specific instructions

Education

  • Master's degree in Public Health (epidemiology & biostatistics) in Biostatistique from Université libre de Bruxelles in 2013
  • Bachelor's degree of Midwifery in Sages-femmes from Haute Ecole Libre de Bruxelles Ilya Prigogine in 2011

Training and Certification

  • Certified Clinical Research Professional in 2017 Certification

Languages

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

Work Preferences

  • Positions I am interested in:
    Pharmacovigilance Officer Drug Safety Officer Clinical Safety Associate Pharmacovigilance Assistant Regulatory Affairs Associate Regulatory Affairs Consultant Regulatory Affairs Assistant
  • Locations I am interested in:
    Belgium Luxembourg
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position
    BrightOwl employee
  • International:
    Yes

Area / Region

Bruxelles, Belgium

Others

Driving License
  • Yes

PERSONALITY ASSESSMENT Detail

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