Medical Coder

OVERVIEW

The Medical Coder is responsible for centralized medical coding activities and serious adverse event (SAE) reconciliation, serving as the lead coding resource for assigned clinical trials. This role ensures the accuracy and compliance of coding practices, maintains Medical Coding Guidelines and SAE Plans, and supports the reconciliation of serious adverse events.

KEY TASKS & RESPONSIBILITIES

Design and maintain Medical Coding Guidelines and Serious Adverse Event reconciliation plans in collaboration with sponsors
Perform precise and consistent medical coding following coding guidelines and utilizing MedDRA and WHODrug dictionaries
Conduct reviews for coding accuracy and consistency reviews including the approval of coded terms and synonym lists
Perform serious adverse event reconciliation across clinical trial databases, safety systems and other relevant sources
Generate coding/SAE queries as necessary
Collaborate with safety, clinical, and data management teams to resolve discrepancies and ensure accurate representation of medical coding and safety information
Document coding decisions and justifications for clarity and auditability
Assist in maintenance activities for coding tools, including User Acceptance Testing (UAT) script creation and execution
Participate in the completion of MedDRA and WHODrug dictionary up versioning workflow activities in alignment with medical coding guidelines
Perform testing of coding tool and deployment of coding/SAE listings in elluminate
Ensure compliance with eClinical Solutions and industry quality standards, regulations, guidelines, and procedures
Other duties as assigned

Education & Experience

Bachelor s degree in relevant health science or professional qualification in a relevant scientific/technical discipline preferred
5+ years experience in the Pharmaceutical/Biotechnology industry with medical coding experience using WHODrug and MedDRA preferred
Knowledge of industry standards, ICH guidelines, and regulatory requirements for medical coding

Professional Skills

Strong 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
Proven ability to work both independently and in a team setting.

Technical Skills
Proficiency in Microsoft Office Applications
Experience working on EDC systems. Medidata Rave Coder experience desirable