• Product Safety Associate

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

    We are currently seeking a Product Safety Associate who will support the Product Safety team on both federally and commercially funded studies.


    • Responsible for monitoring and tracking submitted safety reports (e.g., complete receipt process for safety data/cases including initial receipt, case file creation, and site ackowledgement as well as creating a case into the applicable safety tracking system.)
    • 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
    • Works on multiple projects in compliance with mandatory timelines
    • Performs reconciliation between the clinical and safety databases
    • Supports safety-related study start-up activities (e.g., scans case files, creates inventory lists, ships study documents)
    • Collaborates with internal team and investigative clinical research sites to ensure compliance with safety processes


    • Bachelor's degree (preferably in a health science related field) or Associate's degree in Nursing
    • 0-2 years of relevany experience
    • Experience utilizing a product safety database 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 written and verbal communication skills
    • Strong organizational skills and excellent attention to detail
    • Flexbility to adapt and meet fluctuating business priorities



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