Senior Drug Safety Associate
Performed duties of Sr. DSA working in clinical drug safety role, including QA/QC of drug safety coordinators, performing signal detection, triage of serious adverse event reports by listedness and relatedness, direct communication with Sr. CRO's, submission of 7- and 15-day expedited SAE's, comprehensive narrative writing and quality control for an ESA Phase 3 medication indicated for anemia with monitoring of cardiovascular composite safety endpoints and reconciliation to safety database.
- Expert in all aspects of MedDRA coding and QA/QC for drug safety coordinators
- Therapeutic area specialties: Nephrology and Cardiovascular
- Expert in ARGUS, Clintrace, Scopus drug safety databases. Proficient in ArisG database.
- Performed reconciliation of SAE's with drug safety and clinical trial databases with changes made in conjunction with regulatory compliance.
- Monitoring of composite safety endpoints and signals with data reconciliation to safety database.