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Experiences

Past Experience

  • Publications Assistant

    June 2015 --- March 2017
    • assistant of the Publications managers for the administrative activities within datavision, cars, easy-doc • follow-up of the activities sent to the possible authors by mails • archiving of the various documents like the manuscripts, posters …. • qc of manuscripts, abstracts, posters, Presentations

  • Assistant of the RH

    December 2014 --- June 2015
    • finished my mission at gsk in the Pharmacovigilance department end of november 2014 • support for the rh : formatting cvs, called possible candidates • qc of manuscripts, abstracts for the publication team

  • Safety QC

    August 2007 --- September 2014
    Consultant at gsk since august 2007 in the department of safety/Pharmacovigilance : qc of newcomers (pre-certification and certification), checks of listings for psur and pre-checks before listing of monthly qc, regular qc of pregnancies cases in the spontaneous and Clinical group, monthly qc of cases (includes if events are correctly coded, done following gsk sops and the source data received, etc ....). went twice to tcs mumbai for their trainings : review of their cases during pre and certifications, cases for the monthly qc, tc bi-monthly with them

  • QC in Safety

    January 2007 --- January 2014

  • Manager Safety Compliance and Data entry Safety

    April 1991 --- July 2007
    i stayed in several departments that i summarize : secretariat of several departments for Lab experiences (until 1992) ; Secretary of the Quality Assurance service glp-gcp (1992 until nov1996) ; Secretary of the adverse event review committee (collect the sae report forms, prepare the sae review forms, prepare the agenda and the report of the meetings held once a month ....) ; assistant of the safety officer (nov1996 - jan1999 : collect the sae report forms and Verification of correctness and completeness and enter them, collect information concerning all the saes and enter them in the database, reconciliation for the submission of a pharma product, queries on saes to send to the cros or subsidiaries + fup, search for information on patients in bo and other documents ; documentalist in the Pharmacovigilance department (apr1999 - oct2005 : upon receipt of a new sae/ae, check if duplicate ; enter the case in the database and translate the source document if needed ; coding of all the events as well as the Lab values, disease terms + fups ; preparation with the Physician of the listings + Research in bo from database for psur, reconciliation of studies ....) ; manager gds Process Management in the Pharmacovigilance dept (oct2005 - aug2007 : deviation and the quality internal assessment systems ; check of the procedures ; ensure the tracking of regulatory commitments ; screen the worldwide pv legislation/regulations and adapt processes/systems accordingly ; provide support to our subsidiaries for internal audits, regulatory inspections and ae reporting process matters ; tc with us affiliates ....)

Personality

Self Assessment :
Attention to detailCommunicativeCollaborationInterest in knowledgeOrganizationProactivityResponsibilitySociabilityResult Oriented

Knowledge

Self Assessment :
Adverse Events (AE)Clinical trialsCompliance with regulationsData entryDrug Safety and PharmacovigilanceEnglishInformed Consent DocumentsGood Publication Practice (GPP)Knowledge of the drug development processPharmaceutical IndustryPharmacovigilancePreclinical SafetyQuality Control (QC)Safety reportingSafety trialsSerious Adverse Event (SAE)Standard Operating Procedure (SOP)Vaccines
LinkedIn Assessment :
PharmacovigilanceClinical DevelopmentSOPGCPCROICH-GCPProtocolSecteur pharmaceutiqueEssais cliniquesSciences de la vieSaisie vaccins

Skills and Expertise

Self Assessment :
Search literature on clinical trialsAdverse event reportingArchive documentationAttend seminars, courses and meetings within and outside the companyCapture data on source documentsCollect dataData codingData entryData verificationDocument employees training requirementsEnsure data consistencyInteract with CROsRead medical literatureReport serious adverse events (SAE)Review dataReview medical reportsReview the interpretation of dataSerious Adverse Event (SAE) ReconciliationTrain on site staffUnderstand protocolsVerify dataQuality control process

Languages

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

Work Preferences

  • Positions I am interested in:
    Clinical Safety Associate Clinical Trial Assistant (CTA) Pharmacovigilance Assistant Regulatory Affairs Assistant R&D Assistant Drug Safety Officer Assistant
  • Locations I am interested in:
    Belgium France
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Belgium

Others

Driving License
  • Yes

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