Principal Medical/Clinical Coder - Pharma

Principal Medical/Clinical Coder (12-16 yrs)

Job Location - Bangalore

CTC - Rs.25-28 LPA

Mandatory Skills - MedDRA, WHODrug, SAE Reconciliation

Education & Experience

- Bachelor's degree in relevant health science or professional qualification in a relevant scientific/technical discipline preferred

- 10+ years' experience in the Pharmaceutical/Biotechnology industry with medical coding experience using WHODrug and MedDRA preferred

- Knowledge of industry standards, ICH guidelines, and regulatory requirements for medical coding

- Primary subject matter expert responsible for providing leadership and management responsibilities for medical coders and serious adverse event reconciliation to clients.

- Deliver best practices, technology, and innovative solutions

- Design and maintain Medical Coding Guidelines and Serious Adverse Event reconciliation plans in collaboration with sponsors

- Execute precise and consistent medical coding following coding guidelines and utilizing MedDRA and WHODrug dictionaries

- Conduct reviews for coding consistency including the approval of coded terms and synonym lists

- Enforce a versioning strategy and timeline for routine updates of industry standard dictionaries (MedDRA and WHODrug) in alignment with medical coding guidelines

- Assist in maintenance activities for coding tools, including User Acceptance Testing (UAT) script creation and execution

- Define requirements and collaborate with Data Engineers on development of tools and visuals for coding review and SAE reconciliation via elluminate-

- Ensure adherence to companies quality standards, regulations, guidelines and procedures

- Preform serious adverse event reconciliation across clinical trial databases, safety systems and other relevant sources

- Collaborate with safety, clinical, and data management teams to resolve discrepancies and ensure accurate representation of medical coding and safety information

- Document coding decisions and justifications for clarity and auditability

- Participates in the development and/or maintenance of Standard Operation Procedures,

- Guidelines and/or Work Instructions documents as needed

- Other duties as assigned