Jack is a self-motivated, efficient and reliable drug safety, pharmacovigilance (PV) physician with more than 8 years of experience in pharma/biotech industry with good knowledge of global regulatory, led and conducted medical review of single case (ICSR), medical assessments, proactive signal detection, aggregate safety analysis of clinical drug development (pre/post market). More than 10 years of experience in clinical services of surgical pathology, oncology and biomedical research. Proven track record of cancer research, optimizing procedures 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.
Board Certificate for Surgical Pathologist and Oncologist, issued by China Medical University, Shenyang, China, 1982.
Board Certificate for General Surgeon issued by Medical Bureau of Shenyang, China, 1981.
Teaching and Research:
- Guidance (SOP/work instruction) for physicians who perform causality assessment, alternative etiology and company analysis;
- Physician Training Manual for Clinical Safety Evaluation physician candidate describing SAE case processing, regulatory requirements, expectedness and causality assessment, expedited reporting for clinical trial cases and SAEs in periodic regulatory submission (IND annual report and DSUR) etc.
Oncology, Dept. Safety Surveillance, Amgen Global Regulatory and Safety
•Conducted safety surveillance to identify potential safety signals for Amgen post and pre-marketed products (Neupogen, Neulasta, Kepivance, Angiogenesis inhibitor (AMG 386, AMG 706), IGF Inhibitor (AMG 479) and apoptotic promoters (AMG 951).
•Conducted aggregated safety analyses of phase 1, 2 and 3 clinical trials and draft response to ad hoc queries from FDA, EMEA and other global regulatory agencies and medical communications.
•Performed aggregate safety analysis of adverse event (AEs, SAEs and EOIs) quarterly or periodically for Phase 1, 2 and 3 clinical trials.
•Supported drafting initial version and updates to safety sections of ICF, CDS, DCSI and USPI.
Cell Imaging Facility, Department of Pathology, Medical School
Performed research on 3D reconstruction of cytometric images from normal breast, benign hyperplasia, dysplasia, in situ carcinoma, invasive carcinoma to metastatic carcinoma.
Department of Anatomic and Surgical Pathology, Medical School
•Taught under and graduate medical students pathology and oncology.
•Provided clinical services of surgical pathology diagnosis and autopsies.
•Conducted research on cancer DNA cytometry.
Cancer Institute and Department of Oncology, First Clinical College
•Provided services of surgical pathology and oncology
•Conducted research on cancer and precancers DNA/Image cytometry
Department of Surgical Pathology
•Provided clinical services of surgical pathologic diagnosis and autopsies.
Department of Surgical and Anatomic Pathology
Department of General Surgery, Red Cross Hospital
•Provided clinical services in outpatient surgical and ER department under supervision of senior surgeons
Medical School Thesis on human cancer DNA cytometry and image analysis published by Verlag Shaker, Germany (ISBN 3-86111-352-X, 1993) and graded as “magna cum laude, 1” which represents the best note that can be obtained and the first class honors was proposed by reviewers additionally to the best note that resulted in an award of a DNA Image Analysis System from Alexander von Humboldt Foundation for continuous research. Doctoral work was supervised by Professor Alfred Boecking who is one of the world leading researchers in the field of cancer DNA image cytometry.
Thesis on human cancer DNA cytometry and image analysis published by Verlag Shaker, Germany (ISBN 3-86111-352-X, 1993) and graded as “magna cum laude, 1” which represents the best note that can be obtained and the first class honors was proposed by reviewers additionally to the best note that resulted in an award of a DNA Image Analysis System from Alexander von Humboldt Foundation for continuous research. Doctoral work was supervised by Professor Alfred Boecking who is one of the world leading researchers in the field of cancer DNA image cytometry.
PhD, First Clinical College, China Medical University
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