Drug Safety Scientist
Core
Receives, assesses, obtains follow-up, and reports adverse drug events for company drug products, preparing Periodic Adverse Drug Experience Reports (PADER) and coordinating FDA submissions.
Role type
Drug Safety Scientist (Adverse Event Processing)
Builds
Adverse event case narratives and regulatory submissions for Fresenius Kabi drug products
Domain
Pharmaceutical / Drug Safety / Regulatory Compliance
Required skills
Adverse drug event assessment, PADER preparation, FDA regulation interpretation, cross-functional collaboration, signal detection, data analysis from medical/regulatory sources, case intake management
Preferred skills
Clinical/hospital experience, Aris Global systems proficiency, experience with adverse event safety databases
Technologies
Aris Global, adverse event safety databases, Microsoft Office
Responsibilities
Perform case intake for adverse drug events, oversee preparation of PADERs, coordinate timely FDA submissions, perform quality checks for regulatory submissions, analyze safety data to identify potential health risks
Seniority
Mid-level, hands-on IC