上海招聘

Roche Pharma Development Safety Operation Asia Pacific
Job Description
Position: ___ Safety Evaluation Physician__
Division:Pharma Development
Department:PDS
Location:Shanghai, China
Reports to:Drug Safety Manager or Associate Drug Safety Manager (Safety Evaluation)
Number of Subordinates:0



Basic Function:
Provides supports to the Function Head / line manager in all safety evaluation activities. Is responsible for providing safety support to PDY projects and safety evaluation of Roche products in China. Maintains links and liaisons with external and internal (local and global) parties on safety matters. Owns processes and ensures Roche product knowledge.
Primary Responsibilities include:
· Supports the Function Head/line manager in all safety evaluation activities.
· Works with SSL to contribute to PDY projects including safety support to CTA/NDA applications and safety input to PDY project teams, and to PDY trials as a member of SMT .
· Provides safety support to SRPL activities, including :
· Safety input to Medical studies by reviewing safety section of protocol, CRF, ICF, CSR, SDEA and SMP .
· Safety input to License renewal, safety updates of local labels and solution of high impact cases.
· Works with the relevant PDY and SRPL functions for responses to safety queries from China regulatory agency, media, patients, medical community and investigators.
· Writes and keeps updated local SOPs taking into account the global SOPs when delegated by the line manager.
· Ensures product and safety risk management knowledge.



Qualification and Experience:

· Relevant working experience: at least 3-5 years of clinical and/or DS experience
· Education: Physician of outstanding performance
· Requirements on specific subject(s): preferably internal medicine or oncologist
· Language: Fluent written and spoken English and Chinese with communication skills
· Computer skill: Computer literacy
· Other skills and/or competence:
o Medical knowledge of Roche products
o Communication skills and teamwork
The statements made here are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.


Approved:


_________________________ _______________
Function Head Date:



Acknowledged by job holder:


_________________________ _______________
Name Date:

罗氏药品临床研发亚太中心

罗氏药品临床研发亚太中心位于上海张江高科技园区，是罗氏在中国乃至亚太地区（不包括日本在内）第一个全功能临床药品开发中心，是罗氏药品开发部在全球的第五个研发地区。其前身为2007年10月成立的罗氏药品开发中国中心。

罗氏于2007年在中国率先设立全球药品开发中心，成为在华完成且体现药物研究、药品开发、生产制造和市场销售环节等整体价值链布局的跨国制药企业。此举不仅将加快新药在华的上市时间，使国内广大患者有望更早地受益于创新药物，而且将让更多的中国研究机构、学者、临床医生更早、更主动地参与到全球创新药物的开发过程。

罗氏药品开发中国中心从事药品开发工作，是把经过实验室筛选的分子转变成药物的关键一环，它通过国际多中心临床研究，鉴定药物的安全性和有效性，是驱动药物价值链的引擎。罗氏药品开发中国中心于2009年9月升级为罗氏药品临床研发亚太中心，负责罗氏在亚太地区的药品开发，令更多中国乃至亚太地区的患者尽早受益。