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Experiences

Current Experience

  • Head of Phamacovigilance Unit

    Sint-Lambrechts-Woluwe, Belgium
    Since May 2014
    • Coordination, operational management and practical organization of the pharmacovigilance unit
    • Collection, processing, management and follow-up of pharmacovigilance information
    • Writing and updating of pharmacovigilance SOPs
    • Writing and negotiation of pharmacovigilance agreements with third parties
    • Submission of pharmacovigilance documents in accordance with the GVP requirements
    • Pharmacovigilance point of contact for CA and third parties
    • Responsible for pharmacovigilance training sessions
    • Participation in the Eudravigilance Expert Working group
    • Representative of the EORTC Pharmacovigilance unit in internal/external meetings.
    • Development and maintenance of internal safety software

Past Experience

  • Associate Head of Pharmacovigilance Unit Sint-Lambrechts-Woluwe, Belgium

    August 2013 --- April 2014
    • supporting head of Pharmacovigilance unit in operational tasks (study setup, writing and Negotiation of Pharmacovigilance agreements with third parties, Training of internal staff on Pharmacovigilance,…)
    • perform the task of Pharmacovigilance manager for several studies
    • case management in the safety database: encoding (MedDRA and who dd dictionaries), review, causality assessment, narratives writing, follow-up Data Management, queries to investigators)
    • generating case listings, preparation periodic reports (dsur writing/review,…)
    • sae-ae reconciliation
    • preparation, participation and conduct of audits and inspections (Pharmaceutical companies, mhra, aifa, famhp, swissmedic)
    • study setup (sae-form, crf guidelines, writing of study safety plan,…)
    • review of science)" rel="nofollow">Protocol amendments
    • expedited reporting to regulatory authorities (eudravigilance-evctm, competent authorities, Ethics committees)
    • writing and review guidance for Data entry/coding guidelines and sae-ae reconciliation process
    • validating and Quality Control of database migration (aris-g to safe (inhouse built safety database))
    • writing user requirements (+uats) of inhouse built safety database

  • Pharmacovigilance Manager Sint-Lambrechts-Woluwe, Belgium

    April 2008 --- July 2013
    • case management in the safety database: encoding (MedDRA and who dd dictionaries), review, causality assessment, narratives writing, follow-up Data Management, queries to investigators)
    • generating case listings, preparation periodic reports (dsur writing/review,…)
    • sae-ae reconciliation
    • preparation, participation and conduct of audits and inspections (Pharmaceutical companies, mhra, aifa, famhp, swissmedic)
    • study setup (sae-form, crf guidelines, writing of study safety plan,…)
    • review of science)" rel="nofollow">Protocol amendments
    • expedited reporting to regulatory authorities (eudravigilance-evctm, competent authorities, Ethics committees)
    • writing and review guidance for Data entry/coding guidelines and sae-ae reconciliation process
    • validating and Quality Control of database migration (aris-g to safe (inhouse built safety database))
    • writing user requirements (+uats) of inhouse built safety database

  • Clinical Data Reviewer Mechelen, Belgium

    November 2007 --- March 2008
    • manual data review in edc (eCRF, electronic case report form) and review of data listings.
    • writing of queries.
    • Quality Control on annotated crf.
    • provider cleaning; Laboratory/ecg cleaning; reconciling data between Clinical database and external sources (central laboratories,…).
    • coding; recoding of Adverse Events and concomitant medication according to MedDRA and who drug dictionary.

Personality

Self Assessment :
Attention to detailEfficiencyOrganizationCollaborationDiligenceResult Oriented

Knowledge

Self Assessment :
EVCTMICH-GCPOncology Clinical ResearchPharmacovigilanceSerious Adverse Event (SAE)Compliance with regulationsSafety reporting

Skills and Expertise

Self Assessment :
Design case record forms Interact with physicians Report dataAttend seminars, courses and meetings within and outside the companyCoordinate projectsData codingGuide staffOral presentationReview protocolsSerious Adverse Event (SAE) ReconciliationTrain off site staffWork collaboratively with the other members of the clinical research team EVCTM Expert working groupCreate/review SOPsSAE managementExpedited reporting to regulatory authoritiesSDEA/PV agreement negatiations

Education

  • Master in Biomedical Sciences from University of Antwerp in 2007
  • Bachelor in Biomedical Sciences from University of Antwerp in 2005

Training and Certification

  • FELASA category C certificate in 2007 Certification

Languages

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

Work Preferences

  • Notice Period:
    12 weeks
  • Locations I am interested in:
  • Work From Home:
    Yes, 0 to 1 days per week
  • Work Regime:
    Permanent position
    BrightOwl employee
  • International:
    No

Area / Region

Onze-Lieve-Vrouw-Waver, Sint-Katelijne-Waver, Belgium

Others

Driving License
  • Yes

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