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Drug Safety Associate - AE Case Management

Edison-New Brunswick Metro Area, New Jersey

Post Date: 02/23/2017 Job ID: JN -022017-18447 Industry: Drug Safety - Clinical
  • Healthcare professionals BSN/RN or Pharm D required
    Ensuring that individual Adverse Event Case Reports are evaluated, investigated and accuratelydocumented
    Execute receipt of Drug Safety phone calls and complete telephone AE form
    Create phone call communication logs in ARISg
    Support the triage of cases conducted by Senior Specialist as needed
    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
    Review & update auto-narrative as needed
    Create draft company comments for serious cases
    Develop event rankings
    Create dechallenge / rechallenge determinations
    Develop follow-up needs for AE reports
    Create targeted follow-up letters
    Review and update generated follow-up letters as appropriate
    Authorize (approve) non-serious cases
    Create major modifications following Medical Review
    Update AE reports within safety database to support line listings
    PSUR - COMPLIANCE, STANDARDS, TRAINING & PROJECT MANAGEMENT
    Preparation for Regulatory Inspection
    Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates

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