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Nathalie MANDJEE

Fresnes

En résumé

Diplômée en Master 2 : Sciences du médicament,Spécialité Biologie et Pharmacologie cellulaire,Université de Paris 5,Faculté de Pharmacie.

Mes compétences :
Recherche clinique
R&D
Pathology
Nursing
Cell Culture
surgery
SAE processing
Rheumatology
Reconciliations
Pharmacology
Oncology
Neurology
Nephrology
Molecular Pharmacology
Microscopy
Medical monitoring
Immunology
HIV/AIDS
Gastroenterology
Data Entry
Breast cancer
Argus
Pharmacologie
Neurosciences
Industrie pharmaceutique
Biologie

Entreprises

  • Fresenius - Chargé de pharmacovigilance et d'information/formation médicale

    Fresnes 2016 - maintenant Information médicale:
    - Information médicale auprès des professionnels de santé et de la force de vente
    - Formation des délégués/visiteurs médicaux (médicale et pharmacovigilance)
    - Relecture des documents marketing avant leur soumission aux autorités de santé
    - Recherche et veille bibliographique

    Pharmacovigilance:
    - Gestion de la base de données de pharmacovigilance selon la législation en vigueur
    - Gestion des cas de pharmacovigilance (transmis par l'ANSM, professionnel de santé...)
    - Traduction des fiches CIOMS en anglais
    - Rédaction de PSURs et des synthèses françaises
    - Gestion du suivi de la détection du signal de pharmacovigilance
    - Aide à la rédaction et relecture de procédures de pharmacovigilance
    - Gestion des indicateurs qualité

  • PAREXEL International - Drug Safety Associate

    Paris 2012 - 2016 * Working currently in studies related to various therapeutic areas (Infectiology: HIV; Oncology: Breast
    cancer)
    * Development and review of SAE procedures ;
    * SAE processing, reporting and data entry in tracking tools or in the sponsor safety database (ARGUS,
    DataLabs, CIMS).
    * Management of the safety mailboxes ;
    * Provide support to sites and monitors to report SAE and/or obtain additional information. ;
    * Involved in SAE reconciliation between clinical and safety databases (review of the discrepancies, data
    cleaning and queries to sites).
    * Medical monitoring: Work in collaboration with Medical Monitors and CRAs, regarding Laboratory data
    review
    * Collaborating with the Safety staff including Safety Physicians, Clinical team and Data team.

  • PAREXEL International - Drug Safety Assistant

    Paris 2011 - 2012 * Collection, follow-up and processing of clinical event form, validation for completeness and submission
    * Providing process-related, technical and administrative support to drug safety management and medical
    monitoring activities
    * Archiving, documenting and initial data entry of SAEs forms, Protocol non compliance, and Lab reports
    into safety databases.
    * Working currently in studies related to various therapeutic areas (Oncology: Breast cancer, Ovarian
    cancer; Leukemia)

  • Institute of Myology - Research Assistant

    2009 - 2011 * Bibliographic and literature follow-up ;
    * Work in research and development for the pathology : Amyotrophic lateral sclerosis
    * Development of clinical and therapeutic research protocols
    * Neuromuscular Morphology

  • INSERM U679 - Research Assistant

    2008 - 2008 * Bibliographic and literature follow-up ;
    * Work in research and development for Parkinson pathology ;
    * Working on cell culture and pharmacology

  • INSERM U677 - Lab placement

    2007 - 2007 * Modulation of the chemoreflex during the defence reaction
    * Role of the receptor 5-HT3 of the Nucleus Tractus Solitarius

  • INSERM U677 - Lab placement

    2006 - 2006 * ``System serotoninergic and axis corticotrope:
    - in transgenic mice whose receptor GR. is invalidated in the neurons expressing the receptor 5-HT1A
    - in mice subjected to a protocol of chronic alcoholization''

Formations

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