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HeiTech Services, LLC · 5 months ago

Analyst Coder II (HYBRID)

FDA FIRF - Landover, MD

Full-time

Hybrid

Mid Level

HeiTech Services, LLC is dedicated to attracting skilled professionals and is committed to their success. The Analyst Coder II position involves reviewing and analyzing adverse medical events related to medical devices, processing reports, and ensuring data accuracy in accordance with FDA guidelines.

Document ManagementGovernmentInformation ServicesInformation TechnologySoftware

Growth Opportunities

No H1B

Security Clearance Required

Responsibilities

Analyze all MedWatch reporting forms to determine if they meet the designated Code Blue criteria as identified by FDA

Assign the appropriate product, manufacturer, patient, and device problem codes that correlate with the patient consequences that occurred due to the use of the device

Enter the product code, MFR shortname, patient and device codes into the FDA proprietary database application

Take phone reports from the general public and translate the data to the MedWatch 3500 form

Identify reports not regulated by the Center for Devices and Radiological Health (CDRH) and inform the Supervisor for forwarding to the appropriate FDA Center

Participate in team meetings to discuss coding and other processing issues

Interact with Administrative, Data Entry, Quality Control, and Editor staff to process the reports according to quality guidelines of the contract

Query databases for information needed in the processing of the reports

Ensure the accuracy of data entered into critical fields, per coding principles and procedures and the Standard Operating Procedures (SOPs)

Perform data entry functions as needed; and provide quality assurance of the entered data providing critical feedback to data entry staff using a database designed to capture, track, and report errors

Perform coding in accordance with FDA instructions for coding and ICH Coding Principles for documents

Perform quality control and quality assurance procedures to ensure the appropriate selection of codes

Interface with internal users as well as external stakeholders

Apply and use MS Office Suite tools Microsoft Word and Microsoft Excel

Review and retrieve system data, match output with specifications in accordance with Standard Operating Procedures and resolve discrepancies

Qualification

Medical codingFDA regulationsData entryClinical experienceMS Office SuiteTelephone etiquetteTeam playerAttention to detailOrganizational skills

Required

Must Possess a Bachelor's degree in related health science fields such as nursing, pharmacy, veterinary, and/or certified licensed technicians as appropriate for each center

Good telephone etiquette

Clinical experience in the different medical specialties

Team player, good organizational skills, flexible, open to feedback, and sensitive to time related deadlines

Attention to detail and ability to note and implement the changing regulations and procedures

Basic computer and typing skills

Preferred

Registered Nurses with a Bachelor's of Science in Nursing are preferred, but Licensed Practical Nurses will be considered based on clinical experience

Company

HeiTech Services, LLC

HeiTech Services delivers secure, scalable data processing and information governance solutions guided by our core values of Honor, Excellence and Innovation.

Founded in 1999