上海招聘

Responsibilities:



Supports Safety Operations Specialist in all the Safety activities as described below.

1. Responsible of the collection, reporting and handling of safety information from all sources (including the initial work up and follow up of company or investigator initiated clinical studies, spontaneous and literature reports) associated with Roche products being performed in compliance to the global, local and regulatory requirements and company policy.

2. Responsible of coordinating DS meetings and accurate and timely reporting of single, expedited reports and periodic safety data as required by China sFDA

3. Assists the DS Specialist in providing medical safety information in China for internal customers (marketing team in website and promotional materials) and working with regulatory, legal, public relations and clinical study teams for responses to safety queries from China regulatory agency, media, patients, medical community and investigators.

4. Assists the DS manager in maintaining links and liaison with external and internal (local and global) parties on Safety matters including training of non-Drug Safety personnel in their safety responsibilities and bringing safety expertise and advice to other departments when needed. .

5. Controls day-to-day work (quality check).

6. Owns AE processes and ensures product knowledge



Requirements


1. Relevant working experience: Experience in DS preferable

2. Education: Pharmacist or nurse

3. Requirements on specific subject(s): No

4. Language: Working level of written and spoken English and Chinese with communication skills

5. Computer skill: Computer literacy

6. Other skills and/or competence:

Drug safety skills

Medical knowledge of Roche products

Communication and team building skills

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。