Associate, Drug Safety
Remote
The Drug Safety Associate will be responsible for executing U.S. Adverse Event and pharmacovigilance activities as required by FDA regulations.
Primary Responsibilities:
- Processing serious and non-serious serious adverse events / review of AE case in Argus database
- Interact with data intake and entry group to ensure complete and quality output
- Assist with the writing and maintenance of the Safety Monitoring Plans.
- Ensuring the timely submission of US Adverse Events
- Submission of expedited reports to FDA
Desired Qualifications:
- 5+ years of PV experience in pharmaceuticals, mainly reviewing Adverse Event & Periodic Reports
- Working knowledge of Argus
- Familiarity with FDA regulations and ICH guidance
