Senior Medical Coder: MedDRA/WHODrug & SAE Reconciliation

eClinical Solutions, LLC; Mansfield (MA); On-site; USD 80,000 - 105,000; Full time

Job summary

eClinical Solutions, LLC in the United States is seeking a Medical Coder to lead centralized coding activities and SAE reconciliation for assigned clinical trials, ensuring accuracy and regulatory compliance across coding processes and pharmacovigilance data.

In this role you will design guidelines, perform MedDRA/WHODrug coding, review terms, collaborate with safety and data management teams, document decisions, and support tooling maintenance within the elluminate platform.

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 preferred.
• Knowledge of ICH guidelines, 21 CFR Part 11 and regulatory requirements for medical coding.

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.
• 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

Skills

Medical coding

Attention to detail

Education

Bachelor's degree in health science or related discipline

Tools

WHODrug

MedDRA

Job description

eClinical Solutions, LLC in the United States is seeking a Medical Coder to lead centralized coding activities and SAE reconciliation for assigned clinical trials, ensuring accuracy and regulatory compliance across coding processes and pharmacovigilance data.

In this role you will design guidelines, perform MedDRA/WHODrug coding, review terms, collaborate with safety and data management teams, document decisions, and support tooling maintenance within the elluminate platform.