Safety Coder-MedDRA/WHODrug

esponsibilities:
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 withclinicalteam 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 forsafetyreview and signal detection and patientsafety.
• 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 ofclinicaltrial 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 tosafetyreviewers, study physicians, andclinicalteam 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 toClinicalteam members,ClinicalResearch Organizations, Investigators and investigator sites as needed, in support ofclinicaltrials.
• Impacts medical coding quality and consistency and resultant ability to complete analysis of coded data forsafetyreview, signal detections, issue identification, pro duct approval and patientsafety.

Skills:

• Bachelor's degree with related health science background required (e.g. Nursing, Pharmacy). A relevant coding experience with a minim um of 8+ year drugsafety/ pharmacy experience or 8+ yearsclinicaland 8+ 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 theclinicalcoding process is preferred. Working knowledge of MedDRA, and WHODD is strongly preferred.
• Working knowledge ofClinicaltrial data systems and/or EDC coding tools is a plus.
• Must be detail oriented with the ability to identify discrepancies inclinicaldata and to handle multiple projects and priorities
• Demonstrates effective interpersonal and communication skills. Ability to accurately retrieve data forsafetyor 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 ofsafetymanagement 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.

Requirements:

• MedDRA Coding
• WHODD Coding
• ATC Coding
• Recent use of TMS Platform
• Medidata Experience preferred (not required)
• Familiarity of MedDRA Browser and UMC Insight Tool
• Work Hours: 8:00am to 5:00pm Central Standard Time (occasional flexibility can be discussed with prior approval)
• Flexible to work overtime if needed

Job Types: Full-time, Contract

Pay: Up to $52.68 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift

Work setting:

• Remote

Experience:

• Coding: 4 years (Preferred)
• ATC coding: 4 years (Preferred)

Work Location: Remote