Job Summary
A biopharmaceutical company is in need of a Remote Safety and PV Submission Specialist II.
Candidates will be responsible for the following:
- Assisting in the preparation of the Safety Reporting Plan for safety submissions only projects
- Assisting in study set-up for safety reporting only projects/programs
- Maintaining tracking of safety submissions
Position Requirements Include:
- Minimal travel may be required (up to 5%)
- Safety Database systems and knowledge of medical terminology required
- inimum of three (3) years' Safety and Pharmacovigilance experience required including safety submissions
- Bachelor's Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience
- Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements
- Proficiency in Microsoft Office Suite