天津招聘

Preferred Educational Qualification for the role: 

? MBBS and/or M.D or equivalent Qualifications. 

Preferred experience for the role: 

? Practical experience within clinical or drug safety setting 

? Strong medical background 

? Attention to detail 

? Confident decision maker 

? Knowledge of drug safety or clinical development 

? Good knowledge of and interest in Pharmacovigilance practices 

? Ability to evaluate and interpret scientific data 

? Good knowledge of US and EU pharmacovigilance regulatory requirements 

? Team player with ability to function in a multi – disciplinary environment 

? Self-motivated, able to prioritize and plan effectively 

? Good communication and influencing skills 

? Excellent written and verbal communication skills and ability to present and critically discuss PV data in both internal and external discussions 

? Ability to acquire and assimilate knowledge 

? Computer Literacy 

? Aptitude for training 

Reporting to (Role): Safety Operations Physician Team Leader 

Designee Role: Co- Safety Operations Physician 

Medical Review Responsibilities: 

1. Accountable for the medical review of relevant clinical, other solicited and spontaneous cases (including literature articles), medical assessment (including labeling and causality along with the company causality statement) and overall cohesiveness of individual case safety reports for a particular product or group of products on a national, regional, or global basis in line with regulatory and SOP requirements. 

2. Accountable for the final medical review of ICSRs including decisions on potential SUSARs in a timely fashion and perform tasks such as writing Analysis of Similar Events, communication with the appropriate Safety Science Leader and where appropriate with the Clinical Science Group ensuring that all necessary queries have been addressed. 

Reference SOP: TCS-LS-CQA-003; Version 07 ANNEXURE 02 TCS Confidential Page 2 of 4

3. Responsible for generating, sending and tracking medically relevant queries, together with other PDSO staff, to Affiliates, SAE responsible and Safety operations Centers. 

4. Developing and maintaining thorough knowledge of the appropriate disease biology areas & important safety concerns for marketed drugs and drugs in development for which the Safety Operations Physician is responsible and maintaining awareness of critical AEs/and other issues for assigned product(s). 

5. Working in collaboration with Roche as needed to ensure a timely response to relevant safety queries from Safety operations Centers, SAE responsible and corresponding affiliates, in particular those associated with SUSARs and SARs. 

6. Assuring and maintaining compliance with regulatory and local/global SOP timelines using proactive workflow management. 

Other Responsibilities: 

7. Supporting the Drug Safety teams with medical concepts and awareness of product related topics to ensure quality of adverse event data processing. 

8. Representing the Safety Operations Physicians in regulatory & internal inspections and audits as well as Safety Operations forums and Safety Management Teams, working closely with global PDS personnel to deliver training on the interpretation of single case reports, interpretation of laboratory and other relevant data and on all other medical aspects of Pharmacovigilance. 

9. Identifying trends in medical training needs, highlighting these to Drug Safety management and where appropriate providing additional support and training. 

10. Assuring business continuity/cover provision for single case processing as per requirement. 

11. Achieving established performance metrics for safety processes as advised by Roche. 

12. Ensuring inspection readiness. 

13. Identifying and communicating opportunities to streamline AE processing including improving compliance, quality and efficiency. 

14. Assisting in Drug Safety projects, taking ownership of project as needed. 

15. Responsible for ensuring that individual training records are kept up to date and inspection ready. 

16. Participating or coordinating the investigation of error feedback from Roche as required. 

17. Participating in the identification, implementation and monitoring of corrective and preventative actions as needed. 

18. Once considered competent, provide training and/or mentoring and support to new Safety Operations Physicians. 

19. Reviewing training material, process updates and SOP updates from Roche as requested. 

20. Staying abreast of current training requirements. 

21. Proactively managing workload to meet tight deadlines. 

22. Establish and implement best practice sharing in pharmacovigilance activities. 

Reference SOP: TCS-LS-CQA-003; Version 07 ANNEXURE 02 TCS Confidential Page 3 of 4 

* The statements in this job description are intended to describe the general nature and level of work being performed by those persons assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities and duties required of people assigned to this job.

About Tata Consultancy Services Ltd. (TCS)
Tata Consultancy Services is an IT services, consulting and business solutions organization that delivers real results to global business, ensuring a level of certainty no other firm can match. TCS offers a consulting-led, integrated portfolio of IT, BPO, infrastructure, engineering and assurance services. This is delivered through its unique Global Network Delivery Model (GNDM), recognised as the benchmark of excellence in software development. A part of the Tata group, India’s largest industrial conglomerate, TCS has over 202,500 of the world’s best-trained consultants in 42 countries. The company generated consolidated revenues of US $8.2 billion for year ended March 31, 2011 and is listed on the National Stock Exchange and Bombay Stock Exchange in India. For more information, visit us at ***********.

关于塔塔咨询服务公司（TCS）
        塔塔咨询服务公司是一家专业从事IT服务、商业解决方案和外包服务的公司，致力于为全球客户提供其它公司无可比拟的可靠服务，带来真正的效益。TCS通过其独特的“全球网络交付模式”,为客户提供一系列以咨询为导向的综合IT产品、BPO、基础设施、工程和质量保证服务。该交付模式被誉为软件行业发展的卓越基准。作为印度***的工业集团——塔塔集团旗下的IT咨询服务公司，TCS在全世界42个国家拥有202,500多名训练有素的IT顾问和工程师。截止到2011年3月31日，公司的综合财年收入为82亿美元。公司同时在印度国家证券交易所和孟买证券交易所上市。欲了解更多信息，请访问我们网站***********。

TCS China Profile
TCS pioneered the entry of Indian IT industry in China in 2002 and remains at the forefront of that thrust. TCS is the first WOFE (wholly-owned foreign enterprise) in China and now operates 6 Global Delivery centers (GDCs) --Beijing, Hangzhou, Tianjin, Shenzhen, Shanghai and Dalian.
TCS has been focusing on creating intellectual investments in China by bringing pioneered offshore development methodology into the country. TCS continues to hire talented engineers and IT professionals from the region and its universities, strengthening its existing base in China. Today, TCS China has capabilities in providing services in 9 different languages including English, Mandarin (S & T), Cantonese, Japanese, Korean, Thai, Indonesian, Vietnamese.
In 2005, TCS was invited by Chinese Government to form a Joint Venture (JV) to create a large scale global offshoring base in China. The JV, supported by National Development and Reforms Commission (NDRC), leverages the strengths of the different partners in technology, software development, and consulting, including the best-of-class processes and practices of TCS.
TCS China is serving over 40 Global and domestic clients from Financial Services, Manufacturing, Telecom as well as the Government sector.

TCS中国概况
2002年，塔塔咨询服务公司（TCS）引领印度IT行业率先进入中国市场，成为中国***家印度外商独资企业，并一直保持业内领先优势。
2005年 ，TCS在中国合资成立了塔塔信息技术（中国）股份有限公司（简称TCS中国）。该公司皆在依托中国充足的人才优势，打造一个大型的全球外包基地。
TCS在北京、上海、天津、杭州、深圳以及大连现拥有6个全球交付中心，超过95%的员工是中国本土人才，同时具备9种语言服务能力，包括英文、中文（简体和繁体）、粤语、日语、韩语、泰语、印度尼西亚语和越南语。
TCS中国为全球及国内40多家大型客户提供优质的IT服务，行业涉及金融服务业，制造业，电信。
TCS 成立于1968年
2011财年总收入82亿美元
全球42个国家拥有145个办公机构
超过202,500名员工
在20个国家拥有108个解决方案中心
世界解决方案前十强有6个来自我们的客户
全球***全公司范围内通过CMMI以及PCMM 5级认证的企业

简历投递邮箱：zhijie.ding1@tcs.com