Nurse / Analyst Coder

Role Overview

This position entails evaluating, prioritizing, and analyzing adverse medical incident reports related to medical devices submitted via Med Watch forms, both paper and electronic, to the Food and Drug Administration (FDA). The role includes processing and coding reports from manufacturers, importers, user facilities, healthcare professionals, and customers. While primarily focused on these activities, the Analyst Coder will also be cross-trained for additional tasks based on business requirements.

Key Responsibilities

• Review Med Watch reports to assess if they meet FDA's Code Blue criteria.
• Assign relevant product, manufacturer, patient, and device problem codes aligned with patient outcomes linked to device use.
• Input product codes, manufacturer identifiers, and patient/device codes into the FDA's proprietary database system.
• Convert phone reports from the public into standard Med Watch 3500 forms.
• Detect reports outside the purview of the Center for Devices and Radiological Health (CDRH) and alert the Supervisor for proper referral.
• Participate in team discussions related to coding and report processing issues.
• Collaborate with teams including Administrative, Data Entry, Quality Control, and Editorial to ensure adherence to quality contract standards.
• Utilize databases to query and retrieve necessary report processing information.
• Guarantee data accuracy in key fields by following coding principles, procedures, and SOPs.
• Perform data entry where necessary and conduct quality checks providing feedback through error tracking databases.
• Apply FDA coding instructions and ICH coding principles for documentation.
• Undertake quality control and assurance practices to validate accurate code selections.
• Communicate with both internal users and external stakeholders effectively.
• Employ project management tools including MS Project and MS Office Suite.
• Review system data outputs against specifications per SOPs and address discrepancies promptly.

Candidate Requirements

• Bachelor's degree in health-related sciences such as Nursing, Pharmacy, Veterinary Science, or certification/licensing as applicable for the specific center.
• Strong telephone communication skills and professional etiquette.
• Clinical experience across various medical specialties.
• Ability to work well within teams, exhibit strong organizational skills, adapt to feedback, and meet deadlines.
• High attention to detail alongside the ability to track and implement evolving regulations and protocols.
• Basic proficiency in computer usage and typing skills.
• Capability or eligibility to obtain and maintain an FDA Government Security Clearance.

Preferred Qualifications

• Registered Nurses holding a Bachelor of Science in Nursing degree are preferred; Licensed Practical Nurses will be considered depending on clinical experience.

Additional Instructions

Interested candidates should submit their resume referencing the job code PNA-NAC.