A global therapeutic biotech is looking for an efficient, communicative Drug Safety Specialist to join their team remotely. You will have the chance to assist with ICSR processing through adherence to SOPs and regulations. You will also help monitor information from Phases I-IV clinical trials and post marketed products.
The Drug Safety Specialist will be responsible for:
- Tracking adverse event reports in the Argus database and conducting necessary reconciliation
- Study abstracts in relation to identifying ICSRs and submitting them to the database
- Overseeing the drug safety mailbox
The Drug Safety Specialist should have the following qualifications:
- Bachelor's degree in a life science with at least 3 years of PV experience
- Proficiency in Argus
- Strong familiarity with FDA guidelines, SOPs, and safety plans
- Working knowledge of SDLC validation
Benefits:
- Medical, dental, and vision insurance
- 401k
If you are interested in the Drug Safety Specialist (Contract) position, apply today!
