Senior Medical Coder – FDA Trials (MedDRA/WHO)

Venesco,-LLC-; Frederick (MD); On-site; USD 90,000 - 130,000; Full time

Job summary

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

The ideal candidate holds a Bachelor's degree in Health Sciences or related discipline, MedDRA and WHO-Drug certifications, and at least seven years of medical coding experience with expertise in MedDRA/WHO dictionaries and regulatory data standards.

Qualifications

• Bachelor's degree in Health Sciences or related field.
• MedDRA Certification.
• WHO-Drug Certification.

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

WHO Drug Dictionary

CDISC

Job description

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

The ideal candidate holds a Bachelor's degree in Health Sciences or related discipline, MedDRA and WHO-Drug certifications, and at least seven years of medical coding experience with expertise in MedDRA/WHO dictionaries and regulatory data standards.