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Subject Matter Expert I
3 months ago
MPF Federal is seeking an experienced Subject Matter Expert I – Scientific in the Silver Spring, MD area. The qualified candidate will provide incident review support by assisting the government with incident triage by contacting reporters or firms who submit reports to the FDA Adverse Event Reporting System (FAERS) to gather information about whether the incident was related to a compounded drug and the information about the compounder of that drug. The FDA Adverse Event Reporting System (FAERS) is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to FDA.
Position Summary:
- Provide technical expertise in sorting, reviewing, and organizing incident reports submitted through FAERS.
- Triage incident reports by contacting reporters or firms who submitted the reports to gather information to determine whether the incident was related to a compounded drug and information about the compounder of that drug.
- Chart and catalog information that is reviewed by the point of contact on the incidents team daily to help triage and address the materials that come from FAERS, including MedWatch reports and reports submitted by firms.
- Complete internal information sharing steps via reports, emails, and data entry into FDA systems to ensure that the information is available for use by the Office of Compliance Quality Control (OCQC) team when investigating the incidents.
- Abstract data from regulatory applications and or complex scientific reports using FDA provided Oracle or Access databases or other computer systems for data input as required.
- Perform data validation (database) and quality control functions ensuring that the information is accurate.
- Ensure adherence to all FDA/Federal rules, regulations, policies, guidance documents, and procedures
- Report status of work performed (daily, weekly, monthly, quarterly) as required
- Must have a Bachelor’s Degree in a life sciences field
- Must have 3+ years of medical, life sciences or records information management experience
- Proven ability and experience abstracting data from regulatory applications and/or complex scientific reports
- Proficiency in summarizing, charting and cataloging information in various databases/tracking systems
- Excellent written and oral communication skills
- Must be eligible to work in US and ability to obtain a clearance
MPF Federal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We offer a competitive compensation package including a competitive salary, medical benefits, PTO, holiday pay and more.
