Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Medical Coding Specialist Ii

ICON PLC
2+ years
Not Disclosed
Bangalore, Chennai, India
1 June 4, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill

Medical Coding Specialist II

Location: Chennai / Bangalore, India
Work Model: Hybrid (Office with Flexibility)
Employment Type: Full-Time
Company: ICON plc


Job Summary

The Medical Coding Specialist II is responsible for the accurate coding, classification, and validation of clinical trial data using globally recognized medical dictionaries and coding standards. The role ensures consistency, quality, and regulatory compliance in coding adverse events, medical histories, concomitant medications, procedures, and other clinical data across multiple clinical studies.

The incumbent serves as a subject matter expert in medical coding, collaborating closely with Clinical Data Management, Pharmacovigilance, Biostatistics, Clinical Operations, and Medical Review teams to ensure high-quality coded data for analysis, reporting, and regulatory submissions.


Key Responsibilities

Medical Coding Operations

  • Perform advanced medical coding activities for clinical trial data using industry-standard coding dictionaries.

  • Code and classify:

    • Adverse Events (AEs)

    • Serious Adverse Events (SAEs)

    • Medical History Terms

    • Concomitant Medications

    • Procedures and Interventions

    • Indications and Diagnoses

  • Ensure accurate assignment of coding terms according to established coding conventions and sponsor requirements.

  • Review uncoded terms and determine appropriate coding classifications.


Coding Quality & Compliance

  • Ensure coding accuracy, consistency, and completeness across clinical studies.

  • Perform quality reviews and validation of coded data.

  • Maintain compliance with:

    • ICH-GCP Guidelines

    • Regulatory Requirements

    • Sponsor Standards

    • Internal SOPs

  • Identify and resolve coding discrepancies and inconsistencies.


Medical Dictionary Management

  • Utilize and maintain expertise in:

    • MedDRA (Medical Dictionary for Regulatory Activities)

    • WHO Drug Dictionary

    • WHO Drug Global

    • Other sponsor-specific coding dictionaries

  • Apply appropriate dictionary versions and updates throughout study conduct.

  • Support dictionary upgrades and version reconciliation activities.


Query Resolution & Data Review

  • Collaborate with Clinical Data Management teams to review coding-related queries.

  • Investigate ambiguous medical terms and incomplete source information.

  • Resolve coding discrepancies through medical assessment and data review.

  • Escalate complex coding issues when necessary.


Cross-Functional Collaboration

Work closely with:

  • Clinical Data Management Teams

  • Pharmacovigilance Teams

  • Clinical Operations

  • Medical Monitors

  • Biostatistics Teams

  • Regulatory Affairs

  • Sponsors and Project Teams

  • Provide coding expertise and recommendations throughout the clinical trial lifecycle.

  • Participate in study meetings and coding review discussions.


Coding Standards & Process Improvement

  • Contribute to the development and refinement of:

    • Coding conventions

    • Standard coding procedures

    • Best practices

    • Process documentation

  • Support continuous improvement initiatives related to coding quality and efficiency.

  • Assist in implementation of new coding standards and technologies.


Documentation & Regulatory Support

  • Maintain complete documentation of coding decisions and conventions.

  • Support audit and inspection readiness activities.

  • Assist with preparation of coding-related documentation for regulatory submissions.

  • Ensure traceability and reproducibility of coding decisions.


Training & Knowledge Sharing

  • Provide guidance and support to junior coding specialists.

  • Participate in knowledge-sharing sessions and coding workshops.

  • Stay current with changes to:

    • MedDRA Updates

    • WHO Drug Releases

    • Regulatory Expectations

    • Industry Best Practices


Educational Qualifications

Required

Bachelor’s Degree in:

  • Life Sciences

  • Pharmacy

  • Biotechnology

  • Nursing

  • Medicine

  • Biological Sciences

  • Healthcare Sciences

  • Related Scientific Discipline

Preferred

  • Advanced degree in Pharmacy, Life Sciences, or Healthcare-related fields.