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Drug Safety Specialist

Newark Metro Area, NJ

Post Date: 07/20/2018 Job ID: JN -072018-22099 Job Type: Clinical
  • Healthcare professionals (RN, PharmD) preferred. Experience and capability to deal with high volume of work is required.
    The Drug Safety Specialist, Case Management and is responsible for:
    Ensuring that individual Adverse Event Case Reports are evaluated, investigated and accurately documented
    AE CASE MANAGEMENT
    Receipt
    Execute receipt of Drug Safety phone calls and complete telephone AE form
    Create phone call communication logs in ARISg
    Triage
    Support the triage of cases conducted by Senior Specialist as needed
    Assessment
    Execute QC on key fields of serious cases
    Create key fields updates in ARISg based on QC, as needed
    Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)
    Create narratives as needed
    Develop follow-up needs for AE reports
    Support the identification of corrections and creation of updates in ARISg following medical review
    Update AE reports within safety database to support line listings

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