Dynamic & Experienced Drug Safety Experts Needed

Details: Dynamic & Experienced Drug Safety Expert Needed ( call me directly to discuss) Demonstrated knowledge of safety concepts, per ICH and FDA guidelines per drug safety reporting requirements. • Performs a review of ancillary documentation accompanying ICSR reports and identifies pertinent clinical information for incorporation into the case narrative. • Performs Data Capture and Quality Review for all molecules and serves as a back up for additional projects. • Identifies and initiates requests for case follow up for clinical trials and post marketing adverse events. • Works with Submissions Team Responsible to properly identify US regulatory reporting requirements. • Demonstrates a general understanding of appropriate labeling documents for assigned project(s). • Demonstrates knowledge and understanding of safety exchange agreements (if applicable). • Participates on Study Management Teams (as applicable) • Assists in the development of drug safety presentation for investigator meeting presentations. • Assists in clinical trial reconciliation process (as applicable). • Organizes work load to ensure compliance with regulatory timelines for ICSR reporting. • Ensures departmental workflow processes and timelines are followed.
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