Helen LI joined Pfizer global R&D (PGRD) in April 2008 and currently holds the position of QA Asia Lead at, Pfizer Medical Quality Assurance. Helen’s primary responsibilities are to assure high quality clinical trials and regulatory compliance in Asia Pacific region by implementing Medical QA global strategy and delivering audit activities and other priorities in the Region.
Helen began her clinical research career at AstraZeneca Canada in Jan 1997, and has had increased responsibilities within Clinical Operations at AstraZeneca Canada and Asia/China. Helen advanced to global Clinical Quality Assurance (GCP focused) at AstraZeneca in the US since 2001 and has extensive clinical quality assurance auditing experiences in GCP audits at investigator sites, sponsor systems & processes and documents.
Helen has presented at several international conferences in the healthcare industry, including:
• Drug Information Association, DIA conferences in China and Korea,
• ExL Pharma, GCP Conference in the US
Helen graduated from Fudan University, Medical School, in Shanghai majoring in Clinical Medicine. She has also studied RA/QA Master Degree program at Temple University, School of Pharmacy, Fort Washington PA, in the US.