At HeiTech Services, we value and support our employees, providing challenging opportunities for professional growth. Our mission is to help the Federal Government keep Americans safe.
This non-patient care role involves reviewing, prioritizing, and analyzing adverse medical events related to medical devices submitted to the FDA via MedWatch reporting forms. The role includes processing and coding reports from manufacturers, importers, user facilities, healthcare professionals, and customers. Analysts may be cross-trained for secondary duties.
Essential Functions:
- Analyze MedWatch forms for Code Blue criteria as per FDA guidelines.
- Assign product, manufacturer, patient, and device problem codes relating to device usage consequences.
- Enter data into FDA proprietary database.
- Take phone reports and translate data to MedWatch 3500 forms.
- Identify reports outside CDRH jurisdiction and refer appropriately.
- Participate in team meetings on coding and processing.
- Collaborate with administrative and quality control staff to meet quality guidelines.
- Query databases for processing support.
- Ensure accuracy and quality of data entry and coding following SOPs.
- Interface with internal and external stakeholders.
- Use MS Word and Excel.
- Review and resolve data discrepancies according to SOPs.
Requirements:
- Bachelor's degree in related health science fields such as nursing, pharmacy, veterinary science, or relevant licensed technician certifications.
- Clinical experience across various medical specialties.
- Good telephone etiquette, organizational skills, flexibility, openness to feedback, and deadline sensitivity.
- Attention to detail and adaptability to changing regulations.
- Basic computer and typing skills.
Security Clearance: Must obtain or possess Public Trust Clearance.
Location: Onsite in Landover, MD for training, with potential for remote or hybrid work after training completion.
HeiTech Services is an Equal Opportunity Employer and accommodates applicants as required.
Technology-assisted tools, including AI, may be used during application review; all hiring decisions are by human reviewers.
- Bachelor's degree in health sciences (nursing, pharmacy, veterinary, or certified/licensed technician).
- Clinical experience in various medical specialties.
- Good telephone etiquette.
- Team player with organizational skills.
- Flexible and open to feedback.
- Sensitive to deadlines.
- Attention to detail.
- Basic computer and typing skills.
- Ability to obtain Public Trust Clearance.
Location
Maryland, US
Employment Type
Full-time
Experience Level
Associate
Remote work allowed
Yes
Posted
2 months ago