Remote
Syneos Health

Medical Safety Reviewer III

Job Description:

Minimum requirements:

  • Bachelor’s degree with related health science background required (e.g. Nursing, Pharmacy).
  • A recent direct coding experience strongly preferred with a minim um of 1 year drug safety/ pharmacy experience or 2 years clinical and 3 years drug Pharmacy experience preferred.

Job Description:

  • This position allows for anyone to work remote. Location is not specific to South Carolina
    • Direct clinical coding experience strongly preferred with experience in both MedDRA and WHODrug coding
    • Ensures accurate and consistent coding of medical data, including but not limited to, adverse event verbatim descriptions, medical history, and medication data received from global clinical trials across all clinical areas.
    • Primary coding resource for assigned products and studies.
  • Accurately codes assigned data fields including, but not limited to, adverse events and Medical history using MedDRA and concomitant medications including ATC using WHODrug in accordance with company coding conventions.
  • Effectively performs coding related functions for assigned studies.
  • 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.
  • Keep abreast of coding guidelines internally and externally.
  • Provide consultation to safety reviewers, study physicians, and clinical team members regarding study specific coding questions.
  • Does not initiate strategic decisions, but is responsible for supporting the department, division and company’s strategic direction.
  • Impacts medical coding quality and consistency and resultant ability to complete analysis of coded data for safety review, signal detections, issue identification, pro duct approval and patient safety.
  • Bachelor’s degree with related health science background required (e.g. Nursing, Pharmacy).
  • A recent direct coding experience strongly preferred with a minim um of 1 year drug safety/ pharmacy experience or 2 years clinical and 3 years drug Pharmacy experience preferred.
  • Must have a strong understanding and utilization of medical terminology.
  • Strong experience in coding medical data (adverse events and concomitant medications) and understanding of the clinical coding process is required.
  • Working knowledge of MedDRA and WHODD is required.
  • Working knowledge of Clinical trial data systems and/or EDC coding tools is a plus.
  • Must be detail oriented with the ability to identify discrepancies in clinical data and to handle multiple projects and priorities
  • Demonstrates effective interpersonal and communication skills.
  • Ability to accurately retrieve data for safety or other analysis.
  • Problem solving skills should involve identification of problems and proper escalation to Coding management.
  • Follow global coding conventions and guidelines and identify medical coding needs and requirements.
  • Must have absolute resolution of medical coding data completeness regarding all aspects of safety management utilizing basic knowledge of regulatory guidance’s/ practices.
  • Must be able to work independently as well as in a team environment and effectively collaborate with stakeholders for effective outcomes.