Specialist, Medical Coding

Overview

Support accurate, consistent and timely coding of clinical trial data using MedDRA and WHODrug dictionaries within the Clinical Data Management team.

What you'll do

• Perform medical coding for assigned studies using MedDRA and WHODrug dictionaries in line with company conventions, study requirements and established procedures.
• Review auto-coded and manually coded terms to support coding accuracy, consistency and quality.
• Contribute to Medical Coding Plans and support coding-related study setup activities within medical coding systems.
• Work with EDC Programmers and study teams to implement coding requirements in clinical systems.
• Assist with testing and validating coding configurations and reports.
• Maintain study-specific coding documentation and apply relevant coding conventions and guidelines.
• Support coding reconciliation between Clinical Data Management and Drug Safety.
• Collaborate with Clinical Data Managers, Medical Monitors, Clinical Scientists, Drug Safety, Biostatistics, CROs and other partners to resolve coding issues and queries.
• Identify coding issues, data quality concerns and study risks, and escalate them when needed.
• Support database lock activities and ensure coding documentation and milestone deliverables are inspection-ready.
• Participate in the evaluation and improvement of medical coding systems, automation tools and AI-assisted coding solutions.
• Contribute to process improvements, training and knowledge-sharing activities.

What you'll need

• A bachelor's degree in Pharmacy, Life Sciences, Nursing, or a related healthcare field.
• At least 2 years of medical coding experience within biotechnology, pharmaceutical, CRO or a health-related industry.
• Experience performing clinical data management medical coding using MedDRA and WHODrug dictionaries.
• Working knowledge of MedDRA and WHODrug conventions, hierarchy structures and coding practices.
• Working knowledge of medical coding systems such as Medidata Rave Coder.
• Strong knowledge of medical and medication terminology within clinical development.
• Experience supporting study setup, coding documentation, coding queries and coding quality reviews.
• Familiarity with coding reconciliation between Clinical Data Management and Drug Safety.
• An understanding of clinical development processes and cross-functional interactions.
• Basic knowledge of 21 CFR Part 11, ICH-GCP, GxP, GDPR and applicable regulatory requirements.
• Strong analytical, organizational, problem-solving, communication and attention-to-detail skills.
• The ability to manage assigned deliverables, meet study timelines, and collaborate with cross-functional teams and external partners.

Details

• Location: Hyderabad.
• Work mode: hybrid.
• Many roles are required to be performed on-site; confirm on-site expectations with the recruiter and hiring manager.