Medical reviewer, Chicago

CAREER SUMMARY Self-motivated, detail-oriented reliable drug safety physician with 8-year-experience in pharm/biotech industry with good knowledge of global pharmacovigilance (PV) regulations, clinical medicine and bio-medical research; led and conducted single case (ICSR) medical review in therapeutic areas (TA) oncology, medical assessments, proactive signal detection and aggregate safety analysis in clinical drug development (pre/post market); more than 10-year-experience in clinical services of surgical pathology, oncology and biomedical research; proven track record of cancer research; aligned and optimized processes in PV ICSR review practice in organization to deliver exceptional and business impactful results; Proficient in English and Mandarin-Chinese with pleasant personality and motivation for team work. While working in Global Regulatory & Safety at Amgen, performed aggregate safety analysis of adverse events (AEs, SAEs and EOIs) quarterly or periodically (PSUR and ASR etc.) for clinical trials TA oncology; supported drafting and reviewing updates to safety sections for IB, ICF, CCDS, DCSI and USPI; contributed to develop and draft RMP for assigned compounds in supporting development of angiogenesis inhibitors, Motesanib and Trebananib.

Physician