Supervise a team of Analyst Coders that reviews, edits, prioritizes, and analyzes adverse medical events related to medical devices that are submitted on MedWatch forms to the FDA.
PRINCIPAL 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 special projects as required for the contract.
• Assist Analyst Coder Team with editing, coding, and entering reports to meet contract deliverables.
• Maintains staff by interviewing, selecting, orienting, and training employees and developing staff for professional growth.
• Interact with Administrative, Data Entry, and Quality Control staff to process the reports according to quantity and quality guidelines.
• Query databases for information needed in the processing of the reports.
• Develop, implement, and maintain training and standard operating procedures.
• Serve as the resource person for the resolution of problem reports.
· Bachelors of Science in Nursing and/or 4 years of progressively more responsible managerial experience.
· Clinical experience in the different medical specialties.
· Team player, flexible, and sensitive to time related deadlines.
· An astute attention to detail and the ability to effectively communicate with direct reports, colleagues, senior management and the FDA client.
· Ability to adapt and implement changing regulations and procedures.
Basic computer and typing skills.
