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Clément LEBRUN

VERSAILLES

En résumé

Mes compétences :
Autonomie et sens de l'adaptation
Créativité et réactivité
Neurosciences

Entreprises

  • Clinact - Service Coordinator (pharmacovigilance platform) at CLINACT

    2018 - maintenant - Platform management with 5 medical reviewers, 10 datamanagers, 1 trainee
    - Pharmacovigilance in cardiology, metabolism and neuropsy field; clinical studies and spontaneous
    - Animation of the team (weekly meetings, continuous education ...)
    - Management of resources
    - Follow-up and prioritizing of the activity (quarterly objectives, quality of ADR treated, respect of due dates for submission ...)
    - Literature screening
    - Safety report writing
    - Monthly activity reports to client
    - Invoicing of the activity
  • Hays - Management Team Lead in Pharmacovigilance (internal medicine, acceptation, declaration)

    Paris 2017 - 2018 Pharmacovigilance in internal medicine field, Acceptation on ICSR, Quality control for submission to regulatory authorities.
    Team with 3 medical reviewers, 4 datamanagers, 4 assistants.
    - Employees management (annual revenue, individual point, progress monitoring ...)
    - Management of resources (job interviews for new recruitments, scheduling of absences and holidays, award of bonuses, etc.)
    - Animation of the team (monthly meetings, weekly points, continuous education ...)
    - Follow-up of the activity (quarterly objectives, quality of ADR treated, respect of due dates for submission ...)
    - Management and responses to Servier requests
    - Medical and technical advice for the treatment of cases by datamanagers and medical reviewer
    - Download of ICSR on Eudravigilance site, prioritizing acceptation of notifications following their seriousness
    - Writing monthly activity reports for the client
    - Billing of the activity
  • Hays - Management Team Lead in Pharmacovigilance (internal medicine)

    Paris 2017 - 2017 - Team with 3 medical reviewers, 2 datamanagers, 1 assistant.
    - Employees management (annual revenue, individual point, progress monitoring ...)
    - Management of resources (job interviews for new recruitments, scheduling of absences and holidays, award of bonuses, etc.)
    - Animation of the team (monthly meetings, weekly points, continuing education ...)
    - Follow-up of the activity (quarterly objectives, quality of ADR treated, respect of due dates for submission ...)
    - Management and responses to Servier requests
    - Writing monthly activity reports for the client
    - Billing of the activity
    - Medical and technical advice for the treatment of cases by datamanagers and medical examiner
  • Hays - Drug safety manager (for Servier)

    Paris 2013 - 2017 - Data entry of adverse reaction in the "Argus" base
    - MedDRA Coding
    - Assessment Scoring
    - Narrative writing and translation
  • APHP - Département de la Recherche Clinique et du Développement - Drug safety manager

    2012 - 2013 - Data entry in the database “Safety manager”
    - Coding with MedDRA
    - RAS and DSUR elaboration
    - Reconciliation of bases with partner
    - Implementation of process and quality management tools
    - CIOMS declaration
  • URC/CIC Cochin-Necker - CRA / Project manager associate

    2011 - 2012 Clinical Research Associate:
    - Establishment investigators centers
    - Monitoring (data quality control)
    - Management and monitoring of pharmacy and laboratory
    Project manager assistant:
    - Writing consents and information sheets
    - Feasibility study with PUI
    - Preparation of two CRF
    - Submission to ANSM
  • UMR 7102 Neurobiologie des Processus Adaptatifs - Ingénieur d'étude - Doctorant

    2006 - 2010 De 2006 à 2010 : Chercheur-doctorant, Paris VI, Neurosciences

    Gestion du projet de recherche visant l'identification des facteurs de survie et de développement des cellules nerveuses.

    Double expertise en physiologie et virologie:
    Développement de vecteurs lentiviraux en L3.
    Utilisation des techniques de biologie moléculaire (clonage, PCR quantitative...)

    Présentation en anglais de résultats lors de congrès nationaux et internationaux, publications scientifiques.

    Encadrement et formation de d’étudiants en licence.

Formations

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