Location
Bangalore | India
Job description
The Medical Coder is responsible for performing centralized medical coding activities and serious adverse event reconciliation.
Key Tasks & Responsibilities:
- Review eCRF design for appropriate capture of coded data
- Create specification document to link eCRF fields to appropriate dictionary and version.
- Perform IST to verify coded fields are linked appropriately and that EDC/Coding tool interface is performing as expected.
- Create and maintain coding guidelines using eCS template.
- Create and maintain safety reconciliation plans eCS template to ensure key variables of Safety and Clinical data are reconciled appropriately.
- Create project specification documents for coding listing review and SAE reconciliation (using eCS templates); work with technical developer to QC output and approve programming push to production.
- Code terms in accordance with project-specific coding guidelines
- Create coding queries, ensuring clear description of issue and requirement to update verbatim.
- Produce coding listings in accordance with project plan for review by more senior staff.
- Correct coding as per peer review. Provide coding listings to the client for review/approval Perform serious adverse event reconciliation in accordance with the safety reconciliation plan.
- Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines and procedures.
- Mentor more junior coding specialists and act as coding SME for project teams
- Other duties as assigned.
Education/Language:
- Basic Science/Bachelor of Science degree in health-related field
- Excellent knowledge of English
Professional Skills & Experience
- 2-4 years medical coding using WhoDrug and MedDRA dictionaries
- Minimum 2 years in Pharmaceutical/Biotechnology industry
- Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
- Excellent verbal and written communication skills
- Detail oriented, ability to multitask with strong prioritization, planning and organization skills
- Excellent team player
Technical Skills & Experience
- Proficiency in Microsoft Office Applications
- Working knowledge of MedDRA and WHODrug best practice documents
- Experience with coding application(s), Medidata Rave Coder desirable
Job tags
Salary
