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Feriel NOURI

PARIS

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Entreprises

  • Laboratoire Lilly France - Pharmacien chargé de pharmacovigilance (SNC et Oncologie)

    2004 - maintenant Since September 2004- LILLY France Laboratory –Safety case manager (CNS and oncology)
    • Management of adverse events cases reported spontaneously or associated with clinical trials: data collection, MedDRA coding, case assessment, evaluates the expectedness, define French imputability scoring and writing narratives.
    • Reportability: validate expedited reports from the international data base for submission, in time, to local regulatory agency AFssaps in order to meet regulatory requirements.
    • Work on French intensive monitoring of marketed products according to the risk management plan requirements.

    • Take part in elaboration of answers to health care professional on product safety, writ pharmacovigilance processes and policies and provide answers by phone, after a risk/benefit evaluation to health care professionals.
    • Writing French cases PSURs synthesis for internal-use and perform assessements on the Marketed product's French intensive monitoring.
    • Work in collaboration with clinical research team or CRO on clinical trials adverse event’s management, provide a support to improve and control the quality of their safety reports and train them to pharmacovigilance follow-up conduction in clinical trials
    . Work with the French AQC on French affiliate quality assurance, audits and inspections readiness.
  • Laboratoire Lilly France - Stage en assurance qualité et management des PSURs

    2003 - 2004  September 2003–July 2004– LILLY France Laboratory-Trainee in quality assurance and PSUR management: Within the framework of the master’s degree in: quality assurance
    • Prepare pharmacovigilance department to any authority’s inspection by creating a data base for drugs regulatory status and a schedule for PSURs submission.
    • Take part in internal audit readiness with quality assurance team.
  • Centre de recherche et developpement SAIDAL - Pharmacien au département galénique

    2002 - 2003  October 2002 – June. 2003 – SAIDAL laboratory -Research and Development Center for generic drugs- in Algeria.
    Galenic development and transposition of liquid generic drugs to industrial scale and prepare the galenic department to audit for ISO 9001 certification.

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