Senior Medical Coder — MedDRA & WHO-Drug Expert (7+ yrs)

Venesco, LLC; Washington (District of Columbia); On-site; USD 75,000 - 110,000; Full time

Job summary

Venesco, LLC is seeking a Medical Coder to perform clinical coding activities for adverse events, medical histories, procedures, and concomitant medications for FDA-regulated clinical trials, ensuring accuracy and regulatory compliance.

The ideal candidate will hold MedDRA and WHO-Drug certifications, have at least 7 years of medical coding experience, and be proficient with MedDRA and dictionaries. You will develop coding conventions, review CRFs, support data review and regulatory submissions.

Qualifications

• Bachelor's degree in Health Sciences, Clinical Research, Nursing, Pharmacy, or related discipline.
• MedDRA Certified and WHO-Drug Certified.
• Minimum 7 years of medical coding experience.
• Expertise with MedDRA and WHO Drug dictionaries.
• Experience supporting FDA-regulated clinical studies.
• Knowledge of CDISC and clinical data standards preferred.

Responsibilities

• Code adverse events using MedDRA terminology.
• Code medications using WHO Drug Dictionary.
• Develop coding conventions and coding guidelines.
• Review CRFs and contribute to data review activities.
• Perform coding reconciliation activities.
• Generate coding reports and quality control reviews.
• Support database testing and validation activities.
• Conduct coding-related training for study personnel.
• Maintain coding documentation and audit trails.
• Support regulatory submissions and database lock activities.

Education

Bachelor's degree in Health Sciences, Clinical Research, Nursing, Pharmacy, or related discipline

Tools

MedDRA Terminology

WHO-Drug Dictionary

Job description

Venesco, LLC is seeking a Medical Coder to perform clinical coding activities for adverse events, medical histories, procedures, and concomitant medications for FDA-regulated clinical trials, ensuring accuracy and regulatory compliance.

The ideal candidate will hold MedDRA and WHO-Drug certifications, have at least 7 years of medical coding experience, and be proficient with MedDRA and dictionaries. You will develop coding conventions, review CRFs, support data review and regulatory submissions.