nancy Rivkin

Process and enter SAE data into Argus PV Case Management for clinical trial and spontaneous reports, write safety narratives and MedDRA coding, and manage queries and timelines to ensure regulatory compliance.

Processed SAEs into Argus for HCV post-marketing and clinical reports, authored safety narratives and MedDRA coding, performed QC of 10–20 cases/day and served as client point of contact when needed.

Processed SAEs into Argus for HIV/HCV post-marketing and clinical reports, wrote safety narratives, applied MedDRA coding, and maintained case workload to meet Sponsor/FDA timelines.

Entered oncology adverse events into ARISg and Argus, triaged and registered cases, authored safety narratives with MedDRA coding, contacted sites for follow-up, and ensured compliance with sponsor/FDA timelines.

Collected and assessed adverse events via phone and mail, entered and amended reports in safety databases, and prepared reports for FDA submission following global drug safety procedures.

Reviewed medical records to process provider appeals, selected ICD-9 codes, wrote clinical narratives with recommendations, and managed case workload to meet federal timelines.

Identified and abstracted serious and non-serious adverse events from multiple sources, coded events, wrote narratives, proofed foreign reports and submitted final reports to the FDA.

Reported serious and non-serious adverse events from legal documents and medical records for post-marketing litigation, coded events with MedDRA, authored MedWatch reports and maintained sponsor/FDA timelines.

Abstracted and reported adverse events from legal documents and medical records for Vioxx litigation, coded events with MedDRA, entered data into NWAES/DEIOS and wrote safety narratives while meeting sponsor timelines.

Provided comprehensive nursing care in a pediatric oncology transplant unit, administered chemotherapy, managed neutropenic patients and coordinated multidisciplinary care to ensure patient safety.

Managed care for 4–5 oncology patients per shift in a 30-bed medical-surgical unit, performed assessments and recommended care changes based on clinical evaluation.

Completed a Bachelor of Science in Nursing (BSN) program in 1992.