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Clinical Safety Coder IV-Remote

Company: US Tech Solutions
Location: Irvine
Posted on: January 13, 2022

Job Description:

Job Description
Managers Note

  • 100% remote job
  • Coding clinical data for Phase I to IV
  • Navigating on excel and MS Team.
  • Rave Coder and/or TMS are coding application.
  • ATC coding needed.
  • Adverse event coding, medical product coding .
  • Can navigate between two monitor.
  • MedDRA, and WHO -DD is strongly preferred
    Please emphasize the following
    • Nursing preferred, however will consider PharmD and MD
    • Has performed coding for clinical trials versus only havebackground in PV as a safety specialist
    • Has prior experience using Rave Coder and/or TMS. MedCodr a plus.
    • Has prior experience actually performing ATC coding (vs exposure); this is very important
    • 100% remote (opens to anywhere in US)
      • Ensures accurate and consistentcoding of medical data, including but not limited to, adverse event verbatim descriptions and medication data received from global clinical trials across all clinical areas including identification of prohibited medications and exclusionary medical history.
      • Participates in Centralized Clinical Coding Group (CCCG) process improvement initiatives and serves as asubject matter expert and primary coding resource for assigned compounds and studies.
      • Primary coding resource for assigned products and studies. Accurately codes assigned data fields including, but not limited to,adverse events using MedDRA and concomitant medications using WHO Drug in accordance with company coding conventions and ATC.
      • Prepare and manage coding assignments for new studies and collaborate with clinical team representatives on approach to coding strategy for assigned products and oversight of assigned studies including sign off of document as it impacts medical coding review, product approval, analysis of coded data for safety review and signal detection and patient safety.
      • Identifies when terms or drug names are inadequate, ambiguous or unclear for coding purposes and direct query generation in such aspects. Also,identify and resolve coding discrepancies; and review coding listings for accuracy and consistency.
      • Provide Coding training/overview to Clinical team members, Clinical Research Organizations, Investigators and investigator sites as needed, in support of clinical trials.
        • Bachelor's degree with related health science background required (e.g. Nursing, Pharmacy). A relevant coding experience with a minim um of 8+ year drug safety/ pharmacy experience or 8+ years clinical and 8+ years drug Pharmacy experience preferred but not required.
        • Must have a strong understanding and utilization of medical terminology.
        • Experience incoding medical data (adverse events and concomitant medications) and understanding of the clinical coding process is preferred. Working knowledge of MedDRA, and WHO -DD is strongly preferred.
        • Working knowledge ofClinical trial data systems and/or EDC coding tools is a plus.
        • Ability to accurately retrieve data for safety or other analysis.
        • Must have absolute resolution of medical coding data completeness regarding all aspects of safety management utilizing basic knowledge of regulatory guidance's/ practices.

Keywords: US Tech Solutions, Irvine , Clinical Safety Coder IV-Remote, Healthcare , Irvine, California

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