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Medical Review - Drug Safety

Edison-New Brunswick Metro Area, NJ

Post Date: 07/24/2017 Job ID: JN -072017-19612
  • Ensuring medical accuracy of all aspects of the Case Management group s output
    Developing procedures in support of the Global Safety department having a significant medical context
    Ensuring internal escalation of cases as appropriate
    Execute the medical review of AE reports (narrative, coding, labeling, causality, Pharmacovigilance comment) and manage corrections with Assessment as applicable
    To confirm SUSARs and manage unblindings from double blinded studies
    Contribute to solving reconciliation coding issues/discrepancies
    Review and update generated follow-up letters as appropriate
    Review daily line listing of serious cases and manage corrections with Assessment as applicable
    Contribute to the resolution of issues from case of increased complexity through medical expertise and team interactions
    Manage review of cases and transmission for submission according to internal timelines

    Education: MD or international equivalent

    Skills/Knowledge Required

    Three (3) years relevant experience, including training
    Two (2) years pre- and post-marketing drug safety experience
    Excellent written and oral communication skills
    Knowledge of medical aspects in drug safety
    Working knowledge of MedDRA, WHO-DD is strongly preferred. Knowledge of clinical data management processes is preferred.

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