Purpose:

Maintain the MedDRA governance model and as lead Subject Matter Expert ensures accurate and consistent MedDRA/WHO Drug coding of medical data. Participates in coding process improvement initiatives and serves as a primary coding resource for MedDRA/WHO Drug coding.

Responsibilities:

• Accurate MedDRA/WHO Drug coding of medical data/Reported Terms while maintaining reporting requirements and processes.
• Ensure that all coding activities are completed in a timely and efficient manner in accordance with established guidelines and compliance timelines.
• Continuous quality control of all aspects of MedDRA/WHO Drug coding.
• Identification of inadequate, ambiguous or unclear data for coding purposes and direct query generation.
• Provide MedDRA/WHO Drug coding support to Stakeholders.
• Participate in the development of coding deliverables, coding conventions, Standard Operating Procedures and Work Practices.
• Supporting cross functional/divisional strategies/activities.
• Assist in the maintenance of MedDRA/WHO Drug coding dictionaries for applicable assigned studies
• Assist in development/updating training for coding processes.
• Completes reports and response documentation in a timely, concise, and objective manner.
• Independently identifies process procedure improvements.
• Responsible for maintaining current knowledge of industry coding practices and requirements.
• Investigates possible issues and works with management to identify and report issues that may impact stakeholders, business strategy, and culture.

• Undergraduate degree with related health science background: Bachelor’s degree, Registered Nurse (e.g. RN BSN, RN BS).
• 1 years coding experience, no prior people management experience required.
• Computer proficient (Windows, Word, Excel) Preferred: Proficiency in specific databases.
• Subject matter expertise in industry regulations, processes, and clinical safety. Working knowledge of MedDRA and WHO-DD is required.
• Demonstrated effectiveness working in a matrix environment.
• Subject matter expertise in industry regulations, processes, and safety. Working knowledge of MedDRA and WHO-DD is required.