Medical Coder – MedDRA/WHODrug for Clinical Trials

eClinical Solutions; United States; On-site; USD 80,000 - 105,000; Full time

Job summary

eClinical Solutions is seeking a Medical Coder to lead centralized coding activities and SAE reconciliation across clinical trials. You will ensure coding accuracy, maintain guidelines, and support SAE reconciliation in collaboration with sponsors.

Use MedDRA and WHODrug dictionaries, review coding terms, and generate queries as needed. Join a fast-growing company advancing digital trials with a strong focus on data integrity and compliance.

Qualifications

• Bachelor’s degree in health science or related field preferred.
• 5+ years’ experience in the Pharmaceutical/Biotechnology industry with medical coding using WHODrug and MedDRA.
• Knowledge of ICH guidelines, regulatory requirements for medical coding, and 21 CFR Part 11.

Responsibilities

• Design and maintain Medical Coding Guidelines and SAE reconciliation plans with sponsors.
• Perform precise medical coding using MedDRA and WHODrug dictionaries.
• Review coding for accuracy and approve coded terms and synonym lists.
• Reconcile serious adverse events across databases and safety systems.
• Generate coding/SAE queries as needed.
• Collaborate with safety, clinical, and data management teams to resolve discrepancies.
• Document coding decisions and justifications for auditability.
• Assist in maintenance of coding tools and UAT script creation/execution.
• Participate in MedDRA/WHODrug versioning workflow alignment with guidelines.
• Test coding tools and deploy coding/SAE listings in elluminate.
• Ensure compliance with company and industry standards and procedures.
• Other duties as assigned.

Skills

Medical coding

WHODrug

MedDRA

Quality assurance

Team collaboration

Education

Bachelor’s degree in health science or related field

Tools

MedDTA

MedDRA

WHODrug

Coding guidelines

Job description

eClinical Solutions is seeking a Medical Coder to lead centralized coding activities and SAE reconciliation across clinical trials. You will ensure coding accuracy, maintain guidelines, and support SAE reconciliation in collaboration with sponsors.

Use MedDRA and WHODrug dictionaries, review coding terms, and generate queries as needed. Join a fast-growing company advancing digital trials with a strong focus on data integrity and compliance.