• Product Safety Specialist

    Job Location US-NC-Chapel Hill
    Regular Full-Time
  • Overview

    We are currently seeking a Product Safety Specialist who will function as an integral part of the product safety team and will oversee the day-to-day activities for their assigned projects.


    • Responsible for collecting, monitoring, and tracking in safety reports
    • Performs adverse event data entry and narrative writing for clinical cases
    • Performs first-pass coding of adverse events, medical history and concomitant medications
    • Processes safety cases in compliance with SOPs, Safety Management Plans, and applicable regulations
    • Collaborates with internal team and investigative clinical research sites to ensure compliance with safety processes
    • Works on multiple projects in compliance with mandatory timelines
    • Responsible for performing reconciliation between the clinical and safety database
    • May prepare safety related documents for assigned projects including safety management plans and site training materials
    • May collaborate with the internal project team and the sponsor to determine the scope and specifics of safety data collection, processing, and reporting for assigned projects


    • Bachelor’s degree (preferably in a health science related field) or Associate’s degree in Nursing
    • Minimum of 1 year pharmacovigilance experience or other equivalent clinical or pharmaceutical experience
    • Experience utilizing a product safety database (experience using Argus a plus)
    • Excellent computer skills (e.g. Microsoft Word, Excel, Outlook, and Power Point)
    • Ability to work effectively and collaboratively within a team environment
    • Excellent attention to detail
    • Flexibility to adapt and meet fluctuating business priorities


    EOE. Veterans/Disabled


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