PN Automation

Summary Of Responsibilities 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, 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. Essential Functions 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...

Pn Automation, Inc. is seeking an Analyst Coders to review, prioritize, and analyze adverse medical events related to medical devices reported to FDA Med Watch. The role includes processing and coding reports from manufacturers, importers, facilities, and professionals, with cross-training for additional duties. Applicants should have a health sciences background, strong data entry and coding skills, and the ability to work with QA and editors to ensure quality standards. #J-18808-Ljbffr

Summary of Responsibilities Analyze, prioritize and organize daily workloads for the team for the many different types of reports. Accountable for ensuring that the contract deliverables are met and/or exceeded on the daily basis. Edit reports to maintain the specified Federal privacy and anonymity guidelines. Analyze daily workloads to identify the product, manufacturer, device problems or malfunctions that contributed to the adverse event of the device. Perform editorial responsibilities to assist and guide the data entry staff in the entry of reports into the FDA database. Monitor performance outcomes and conduct periodic evaluations for direct reports. Coach, counsel and discipline direct reports as needed to achieve favorable performance outcomes. Perform strategic thinking to mitigate problems that could adversely impact the project. Supporting Responsibilities Participate in team and management meetings to discuss coding and personnel issues. Participate in...