Job Description

• Job Title : Clinical Safety Coder – 100% Remote
• Duration : 12 months (possible extension)
• Work Hours : 8:00 am to 5:00 pm Central Standard Time (occasional flexibility can be discussed with prior approval)

What we are looking for:

• MedDRA Coding
• WHODD Coding
• ATC Coding
• Recent use of TMS Platform
• Medidata Experience preferred (not required)
• Familiarity of MedDRA Browser and UMC Insight Tool
• Flexible to work overtime if needed

Job Description:

• Ensures accurate and consistent coding 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 a subject 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 limit ed to, adverse events using MedDRA and concomitant medications using WHO Drug in accordance with company coding conventions and ATC.
• Effectively performs coding ¬related functions for assigned studies. 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.
• Participate in identification of clinical trial prohibited meds, exclusionary medical history and appropriately issue escalation.
• Participate in the development of coding conventions, Standard Operating Procedures and Work Practices as a member of coding team.
• 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.
• Provide Coding training/overview to Clinical team members, Clinical Research Organizations, Investigators and investigator sites as needed, in support of clinical trials.
• 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.

Qualification:

• Bachelor’s degree with related health science background required (e.g. Nursing, Pharmacy). A relevant coding experience with a minim um of 2–4-year drug safety/ pharmacy experience or 2-4 years clinical and 2- 4 years drug Pharmacy experience preferred but not required.
• Must have a strong understanding and utilization of medical terminology. Experience in coding 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 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.
• Ability to contribute to the definition and timely achievement of area projects and goals and serve as a representative for Coding on cross functional projects.
• 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.

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