Si Nae Lee
About Si Nae Lee
Si Nae Lee is a PV Audit and Inspection Readiness Manager at Bristol-Myers Squibb and a Senior Drug Safety Manager at ICON plc.
Pharmacovigilance Audit and Inspection Readiness Manager
Si Nae Lee is currently serving as the PV Audit and Inspection Readiness Manager at Bristol-Myers Squibb. In this role, she focuses on ensuring that the pharmacovigilance (PV) systems meet regulatory standards and are fully prepared for audits and inspections. Her responsibilities likely include evaluating and improving PV processes, overseeing audit readiness activities, and managing responses to inspection findings.
Senior Drug Safety Manager at ICON plc
Since January 1, 2019, Si Nae Lee has been employed as a Senior Drug Safety Manager at ICON plc. In this capacity, she takes on crucial responsibilities in the management of drug safety operations. Her role involves overseeing the safety profiles of pharmaceutical products, ensuring compliance with regulatory requirements, and managing risk-benefit assessments. Her work contributes significantly to the protection of patient health and safety.
Experience in Pharmacovigilance Audit and Inspection
Si Nae Lee has extensive experience in pharmacovigilance audit and inspection readiness. This experience includes managing the preparation and processes needed to meet compliance standards. She works on ensuring that the pharmacovigilance systems are consistently audit-ready and maintain the highest standards of regulatory compliance. Her role involves detailed planning, system evaluations, and handling regulatory queries and findings.
Managerial Roles in Drug Safety and Pharmacovigilance
Si Nae Lee has held multiple managerial roles in the fields of drug safety and pharmacovigilance. Her positions have involved overseeing safety management systems, ensuring regulatory compliance, and leading cross-functional teams. Her leadership and expertise contribute to the effective management of drug safety protocols and the successful navigation of regulatory audits and inspections.