Medical Coder

About the role

The Medical Coder is responsible for centralized medical coding activities and serious adverse event reconciliation for assigned clinical trials, ensuring accuracy and compliance with coding guidelines.

Key responsibilities

• Design and maintain Medical Coding Guidelines and SAE reconciliation plans in collaboration with sponsors.
• Perform precise medical coding using MedDRA and WHODrug dictionaries.
• Conduct coding accuracy reviews and approve coded terms and synonym lists.
• Reconcile serious adverse events across trial databases, safety systems and other sources.
• Generate coding/SAE queries and collaborate with safety, clinical and data management teams to resolve discrepancies.
• Document coding decisions for auditability and support maintenance of coding tools, including UAT script creation.
• Participate in MedDRA and WHODrug versioning workflows and test coding tools in elluminate®.
• Ensure compliance with eClinical Solutions and industry quality standards, regulations and procedures.

Required profile

• Bachelor’s degree in a health science or related scientific discipline (preferred).
• At least 5 years of experience in pharmaceutical/biotechnology medical coding, preferably using WHODrug and MedDRA.
• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology.
• Excellent verbal and written communication skills.
• Detail‑oriented with ability to multitask, prioritize and organize work.
• Proven ability to work independently and as part of a team.

Required skills

• Proficiency with MedDRA and WHODrug coding dictionaries.
• Experience with Microsoft Office applications.
• Familiarity with electronic data capture (EDC) systems; Medidata Rave Coder experience desirable.