Project Support Specialist

5 days ago

Hyattsville, United States BlackFish Federal LLC Full time
Project Support Specialist (MDR)

Location: Landover, MD

Status: Full-time

Position Description:

This position is responsible for providing direct support to device manufacturers, health care providers, user facilities and/or voluntary reporters when submitting adverse event reports to the U.S. Food and Drug Administration (FDA). The primary function of the Project Support Specialist (PSS) is to identify, investigate, and resolve any issues that could preclude a reporter from successfully submitting their adverse event report to FDA.

Required Qualifications:
  • College degree, preferably in science or information management.
  • Ability to lead special project teams is preferred, with a minimum of three (3) years of experience in records management.
  • Ability to implement SOP's and train staff in their use.
  • Must have knowledge and experience with medical devices and medical device terminology.
  • Ability to type 40 words per minute with no more than two errors.
  • Proficient with office automation tools such as Microsoft Office and other common desktop applications.
  • Must have a combination of excellent analytical skills and a high attention to detail.
  • Possess excellent verbal and written communication skills.
  • Must be able to work in a fast-paced electronic production environment.
  • Must have experience with reading and classifying scientific regulatory documents.
  • Must have experience and working knowledge of the FOIA and redaction process.
  • Must possess excellent customer service skills.
  • Possess or be able to obtain/maintain a Government Public Trust Security Clearance.
  • Must possess excellent computer skills and experience with the querying and use of databases.
Essential Functions:
  • Resolve submission issues with adverse event reports that prevent them from being accepted within proprietary FDA database systems. This could include, but may not be limited to:
    • Invalid report numbers
    • Missing / Insufficient Event Descriptions
    • Duplicate reports
    • Test Reports
    • Reports submitted in error
    • Initial reports submitted as Supplemental reports
    • Non-Reportable Events
    • Incorrect reporting form
  • Conduct quarterly User Facility (UF) audits to ensure the most current UF information is on record with FDA.
  • Collaborate via phone and email with device manufacturers, User Facilities, and reporters to resolve data anomalies that prevent the acceptance of their adverse event report.
  • Redact patient and/or manufacturer confidential data as needed on current and aged problem reports.
  • Support daily, weekly, and monthly production reporting to capture performance statistics for resolved problem reports.
  • Provide ad hoc support (e.g., redaction, 806 recall, priority report processing) as needed when requested.
  • Assist with the creation and/or maintaining project SOP's.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Conditions:
  • Work is primarily performed within a hybrid work environment with some work performed onsite and some telework.

This document is not intended to cover or contain a comprehensive listing of all job-related activities, duties or responsibilities that are required of the employee. Due to the nature of the industry, job tasks may be changed as necessary to meet the needs of the customer.

BlackFish Federal. is an equal opportunity employer providing equal employment opportunities (EEO) to all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.

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