A drug safety specialist provides support for their organization related to drug safety. They are often responsible for creating and modifying medical reports to send to Food and Drug Administration, and these specialists may also help track drugs (including where they are shipped), perform auditing duties and provide demonstrations on safety regulations. Other duties the drug safety specialist may perform include reviewing information on serious adverse events and facilitating discussions as necessary on these events with health care workers and other relevant professionals, as well as determining reporting requirements on serious adverse events and preparing reports as needed. Drug safety specialists must help their organization maintain up-to-date databases on drug safety that are both relevant and easy to use, as well as work efficiently to meet all relevant deadlines.
This position generally requires at least a bachelor's degree in a healthcare-related field, although a more advanced degree may be preferred. Relevant drug safety experience is generally required or preferred as well. Drug safety specialists should have good communication and interpersonal skills, as well as be proficient with basic computer programs such as the Microsoft Office suite and be able to work well on their own with minimal supervision.
Drug Safety Specialist Tasks
Complete follow-up, research cases.
Enter data into databases and systems, create initial reports.
Read, assess and organize all reports of adverse events.
Update and edit reports and databases or systems as needed.