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.
- 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.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced