Experienced Senior Medical Coder, specializing in MedDRA and WHODrug coding and Serious Adverse Event (SAE) Reconciliation. Proficient in navigating complex medical terminology, collaborating with cross-functional teams, and adhering to industry standards. Proven ability to contribute to the precision and consistency of coded data, ensuring patient safety and compliance with regulatory requirements. Adept at collaborating with cross-functional teams, implementing quality control measures, and contributing to the successful execution of clinical research.

Key Tasks & Responsibilities

• Function as a Coding and SAE subject matter expert providing guidance to clients on best practices, technology, and innovative solutions
• Perform serious adverse event reconciliation across clinical trial databases, safety systems and other relevant sources
• Generate coding/SAE queries as necessary
• Collaborate with safety, clinical, and data management teams to resolve SAE discrepancies
• 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 accuracy and consistency reviews 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
• Perform testing of coding tool and deployment of Coding /SAE listings in elluminate®
• Ensure adherence to eClinical Solutions/industry quality standards, regulations, guidelines and procedures
• Document coding decisions and justifications for clarity and auditability
• Other duties as assigned
  
  

Education & Experience

• Bachelor’s degree in relevant health science or professional qualification in a relevant scientific/technical discipline preferred
• Strong experience with performing SAE Reconciliation activities.
• Strong experience in SAE query/discrepancy management, designing and maintaining Serious Adverse Event reconciliation plan.
• 8+ 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 and SAE reconciliation.
  
  

Professional Skills

• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Excellent verbal and written communication skills
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Proven ability to work both independently and in a team setting
  
  

Technical Skills

• Proficiency in Microsoft Office Applications
• Experience working on EDC systems.
• Medidata Rave Coder experience desirable