Drug Safety Specialist
Received adverse events and review for potential patient risk and severity to determine if the reportable nature of event.
- Responsible for collecting information and updating/opening complaint files in the Complaint Management Database
- Interface with customer service, health care professionals, caregivers, and patients to gather additional information required for complaint investigations and adverse drug experience (ADE) reporting.
- Responsible for the completion and submittal of ADE reports.
- Review complaints for a potential FAR and prepare an NDA field alert report to submit to the FDA in accordance with regulations
- Maintain current knowledge of the FDA Quality System and FDA regulations for medical device and adverse drug experience reporting (21 CFR part 803, 829, 211, 312, and 314)
- Manage workflow to ensure timely ADE reporting, customer follow up, and closure of complaints in compliance within FDA and corporate guidelines