Rachel Gao

• Developed and maintained pharmacovigilance system, including Standard Procedures and drug safety database • Oversaw processes of Drug Safety Operations and performed signal detection and risk management throughout the product lifecycle in compliance with the relevant national and international regulatory requirements • Reviewed and assessed drug safety profile, while providing consultation and guidance to project and investigating team in developing clinical development strategies and plans • Prepared, reviewed, organized and/or presented safety summary for Clinical Trial/New Drug Application to address safety-related inquiries prior to final launching • Provided input to synopsis and protocol design, Investigator Brochure and other materials like Information Consent Form, Statistical Analysis Plan, Case Report Form etc. • Complied Risk Management Plan and Development Safety Update Report for Health Authority submission • Reviewed and provided input to the Pharmacovigilance Agreement with Business Partners

• Organized Pharmacovigilance systems as per local and EU regulations • Coached and mentored teams in following company relevant standard procedures, while ensuring the smooth processes of pharmacovigilance operations and project management • Effectively reviewed protocols, Case Report Forms and Statistical Analysis Plans of product local registered trials and post-marketing trials, to ensure safety assessments are collected properly as per local regulations and trial objectives • Managed Adverse Event of special interest for the Asian market • Reviewed and evaluated Serious Adverse Events in trials and Adverse Drug Reactions in spontaneous reports and sent queries as necessary • Provided advice to local Regulatory Affairs team for Product Insert update and other communication or submission • Organized safety supports in Independent Data Monitoring Committee for clinical trials and Drug Safety Committee for spontaneous drug safety crisis management

• Collected, followed and submitted adverse events reported spontaneously and in clinical trials according to regulatory requirements and company policies, and answered inquiries from HA. • Trained internal team, Investigators and third parties on AE collection and processing • Participated in clinical kick-off meetings • Timely communications to all parties involved on emergent safety matters • Fully responsible in implementing Risk Management Plan, while ensuring full compliance. • Reviewed contracts of marketing activities involving third parties to ensure the relevant criteria were met