Job Summary
A clinical stage biotechnology company is searching for a person to fill their position for a Remote Safety Medical Reviewer Associate Director.
Individual must be able to fulfill the following responsibilities:
- Perform signal detection activities
- Prepare Analysis of Similar Events (AOSE) summary for SUSARs requiring safety reporting
- Support or draft safety related documents and safety responses regarding safety issues
Required Skills:
- MD, DO or NP with 2+ years of experience in Drug Safety and PV
- Thorough knowledge of current US, Global, and ICH safety reporting regulations and guidelines
- Worked with a drug safety database (ARGUS experience helpful) and have had responsibility for medical review of SAE reports