周晓枫

聘期:2015.03-2018.03

姓      名

 Xiaofeng Zhou (周晓枫)

性      别

 

职      称

 

学      历

 

电      话

 

传      真

 

电子邮件

 

个人主页

 

通讯地址

 

专业

Epidemiology

 


职务/职称

Director, Worldwide Safety and Regulator, Pfizer Inc., New York, USA (全球安全性和注册部总监, 美国辉瑞制药公司,纽约总部)

 


个人教育

Ph.D, Epidemiology, University of Michigan, Ann Arbor, MI

M.S. Statistics, Virginia Polytechnic Institute and State University (VPI), Blacksburg, VA

M.S. Applied Economics, Virginia Polytechnic Institute and State University, Blacksburg, VA

M.S. Food & Nutrition Planning, University of Philippines, Los Banos, Philippines

B.S. Mechanical Engineering, Southeast University, Nanjing, China

 


研究领域

Epidemiology method

Pharmaco-epidemiological database studies

Observational Data and medical big data for drug development and safety

Active drug safety surveillance

 



工作经历

1/2008-present: Director/Associate Director, Epidemiology, Worldwide Safety & Regulatory, Pfizer Inc. 219 E. 42nd street, NYC, NY

2/2001-12/2007: Associate Director/Manager, Risk Management and Epidemiology, Clinical Safety and Epidemiology, Pfizer Inc. Ann Arbor, MI

2/1999 - 2/2001: Statistical Project Manager/Senior Statistician, Drug Safety Surveillance (DSS), Parke Davis Pharmaceutical Division, Warner-Lambert, Ann Arbor, MI

09/1995 - 02/1999: Project Lead/Analyst, Clinical Reporting System (CRS), Parke Davis Pharmaceutical Division, Warner-Lambert, Ann Arbor, MI

08/1992 - 07/1995: Graduate Research Associate, Department of Statistics and Department of Applied Economics, VPI, Blacksburg, VA

11/1987 - 07/1992, Lecturer/Deputy Director, Economics Department, Nanjing University of Finance and Economics, Nanjing, China

5/1986 - 10/1987, Visiting Scholar, Human Nutrition and Ecology, University of the Philippines at Los Banns, Philippines (United Nation Fellowship)

8/1982 - 07/1986, Assistant Professor, Food Engineering Department, Nanjing Food and Economic Institute, Nanjing, China

 


研究成果 (Summary)

1. Over 40 publications at major peer reviewed journals and presentations at major international/national conferences.

2. Led multi-company and cross divisional teams and successfully completed multiple high profile projects with extensive collaboration/engagement with internationally/nationally well-known experts from leading research universities in US, EU, and Canada  on active surveillance methodological research to enable the Pfizer’s industry leading position in the space of active drug safety surveillance and contribute substantially to build Pfizer’s in house capacity using real world data for new drug preparedness of active surveillance.

3. Led design, execution, and successful delivery of numerous epidemiological database studies and analyses for supporting over 20 drug products across multiple therapeutic areas in Neuroscience, Cardiovascular, Endocrine, Rheumatology, Oncology, Urology, and Vaccine/Infectious Disease. Significant contributions to numerous regulatory submissions and responses to US FDA (Food and Drug Administration), EMA (European Medicine Agency), MAH (Marketing Authorization Holder, UK), as well as FDA advisory meetings.

4. Successfully organized and led a workshop entitled "Harmonizing Methods and Data across Multiple Databases: Beautiful Music or Cacophony?", Montreal, Canada, August, 2013, by collaborating with key investigators at major US and EU active surveillance initiatives (US FDA Mini Sentinel Initiative, Observational Medical Outcome Partnership (OMOP), and EU_ADR) as well as a well-known UK observational data vendor of electronic medical records (EMRs) – THIN data. Also served as one of the speakers at the workshop: “Common Data Models in an Industry Setting: Case Study and Lessons Learnt”

5. Played  key role in developing Pfizer- EPI China strategy and multiple teaching experiences on pharmaco-epidemiology at Beijing University, Fudan University, and Pfizer China

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