This position is responsible for reviewing,prioritizing, and analyzing adverse medical events related to medical devices that are submitted on Med Watch reporting forms via hard copy or electronically to our customer, the Food and Drug Administration (FDA). Additionally, this position is responsible for processing and coding a variety of reports from device manufacturers (MFR), importers, user facilities, health care professionals, and customers. While Analyst Coders may be assigned to perform the primary functions shown above, they will also be cross-trained to perform secondary duties according to business need.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
·Analyze all Med Watch 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 short name, patient and device codes into the FDA proprietary database application.
·Take phone reports from the general public and translate the data to the Med Watch 3500 form.
·Identify reports not regulated by the Center for Devices and Radio logical 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 principle sand procedures and the Standard Operating Procedures (SOP's).
·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 project management tools such as MS Project and MS Office Suite.
·Review and retrieve system data, match output with specifications in accordance with Standard Operating Procedures and resolve discrepancies.
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 are required.
·Possess or be able to obtain/maintain a Government FDA Security Clearance.
·Registered Nurses with a Bachelor's of Science in Nursing preferred, but Licensed Practical Nurses are considered based on clinical experience.