Senior Medical Coder — MedDRA/WHODrug & SAE Expert

Socket.dev; United States; On-site; USD 80,000 - 105,000; Full time

Job summary

eClinical Solutions seeks a Medical Coder to lead centralized coding and SAE reconciliation for assigned clinical trials. You will ensure accuracy and compliance with coding guidelines and maintain MedDRA and WHODrug dictionaries.

You will collaborate with safety, clinical, and data management teams to resolve discrepancies and support QA activities, while contributing to a fast-growing culture focused on innovative data management in healthcare.

Qualifications

• Bachelor's degree in a relevant health science or related field is preferred.
• 5+ years in Pharmaceuticals/Biotechnology with medical coding using WHODrug and MedDRA preferred.
• Knowledge of industry standards, ICH guidelines, and regulatory requirements for medical coding.
• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology.
• Excellent verbal and written communication skills.
• Detail oriented with strong prioritization, planning and organization skills.
• Proven ability to work independently and in a team.

Responsibilities

• Design and maintain Medical Coding Guidelines and SAE reconciliation plans.
• Perform accurate medical coding using MedDRA and WHODrug.
• Review coding accuracy and approve coded terms and synonym lists.
• Conduct SAE reconciliation across trial databases and safety systems.
• Generate coding/SAE queries and collaborate with safety, clinical, and data management teams.

Skills

Attention to detail

Verbal and written communication

Multitasking and prioritization

Independence and teamwork

Education

Bachelor's degree in health science or related field

Tools

WHODrug

MedDRA

Job description

eClinical Solutions seeks a Medical Coder to lead centralized coding and SAE reconciliation for assigned clinical trials. You will ensure accuracy and compliance with coding guidelines and maintain MedDRA and WHODrug dictionaries.

You will collaborate with safety, clinical, and data management teams to resolve discrepancies and support QA activities, while contributing to a fast-growing culture focused on innovative data management in healthcare.