长沙招聘

Position: Database Project Expert (DBPE)
Line Manager: Managers of Global Analytical Reporting, Global AWARE Operations, Validation, Metrics, Doc and Safety Data
Location: Shanghai, China
JOB SUMMARY Database Project Expert (DBPE)
Database Project expert role which encompasses many of the operational aspects within the System Support and Data Management unit. This role can be involved in different aspects of day to day operations and maintenance (configuration, validation, analytic reporting) as well as maintenance of the current safety database system as well as development and project support of enhancements, change controls and future tools to support GPV.
Depending on the incumbents experience and skills this role can include creating and validating ad hoc reports and queries needed to support Pharmacovigilance and signal detection activities as well and the review of these reports and queries to verify that they are accurate and consistent with the request from the subject matter expert.
The database project expert can also participate in the configuration of the safety database as well as the development, validation and maintenance of the system enhancements including the generation and approval of documentation to support the sanofi methodology PUMA (Project Unified Methodology Approach).
PRINCIPAL DUTIES AND RESPONSIBILITIES
Participate in discussions with Global Safety Officers to develop strategy for designing AE database searches. Proactive approach that should increase the efficiency of the development and validation process and shorten cycle time. Interface with users to ensure understanding of the request, suggest strategies for handling the request, and provide target date for delivery of the report. This will allow for efficient handling of requested ad hoc or standard reports and allow for timely delivery of these reports to meet department needs. Database Project expert role can be involved in different aspects of day to day operations and maintenance (configuration, validation, analytic reporting) as well as maintenance of the current safety database system including periodic MEDdra Upgrades, the configuration of the safety database as well as the development, validation and maintenance of the system Responsible for working with end users and GPV to define business requirements for the system or related sub systems. Responsible for troubleshooting system issues as they arise and working with the ITS departments to ensure rapid resolution of the problem. Develop ad hoc and standard queries and reports (SQL, variable reports, BI or Business Objects) according to the user requirements, database model and data entry conventions. This will allow use of current technology to meet the needs of the users to allow them to be able to effectively obtain the data they need for decision making purposes. Provide validation of reports generated by the Ad Hoc Reporting specialist prior to release. Ensure the accuracy of the data included in reports as these are used to support the safety of our products with regulators. Develop change control documents and test scripts to be used for validation. Ensure consistent, reproducible results in the validation process. Generate PUMA documents required for system development in particular requirements specification, validation strategy and user acceptance testing. These documents are needed for the development/maintenance of computerized systems to ensure the conformity of the system with the end users requirements. Interface with IT department to ensure that user requirements are understood prior to system development. This will allow for consistency in the final system deliverables and ensure consistency with the desires of the users.
职位要求：
REQUIREMENTS
Knowledge And Skills:
Understanding of the principles and goals of Pharmacovigilance
Knowledge of Oracle database, SQL
Ability to author technical documents in english
Ability to work in multidisciplinary and international teams
Strong attention to detail
Proficient communication (oral/written) in English
Formal Education And Experience Required:
BS degree (scientist plus computer science) or previous experience in pharmacovigilance
Previous system/validation experience required
Experience in working in a highly regulated environment, minimum 2 years
Knowledge on a query tool (BI, Business Objects, OBIEE) desirable
Previous experience working with AERS/Argus safety database
Previous experience in computerized system methodology for implementation and validation of IT systems

赛诺菲集团
赛诺菲集团是一家全球领先的多元化医药健康企业，专注于患者需求，传播健康。
 全球100,000余名员工，业务遍及100个国家
 新兴市场实力均衡，表现强劲，位列***
 多元领域，覆盖处方药、健康药业产品、疫苗和动物保健品
 疫苗领域的领导者
 领先动物保健市场
 2011年集团净销售额达334亿欧元

赛诺菲在中国
赛诺菲是首批在中国开设办事处的跨国制药集团，也是国内增长最快的医药健康企业之一。目前，赛诺菲在中国200多个城市拥有6000余名员工。
   
传承悠久历史、持续开拓进取
赛诺菲一直以来秉承对中国的承诺。1982年，赛诺菲成为首批在中国开设办事处的跨国制药企业之一。今天，赛诺菲已跻身中国医药健康市场的领军企业。赛诺菲的中国总部位于上海，并在北京、天津、沈阳、济南、上海、杭州、南京、武汉、成都、广州和乌鲁木齐共设11家区域办公室。

独特的医药健康产品系列、满足中国公共卫生需求
从预防到治疗，赛诺菲全方位满足中国的公共健康需求。集团的疫苗事业部赛诺菲巴斯德是中国领先的疫苗企业。赛诺菲在心血管/血栓、糖尿病、肿瘤、内科和中枢神经系统等关键的治疗领域拥有领先产品。2010年，杭州赛诺菲民生健康药业有限公司的成立标志着赛诺菲进入中国的非处方药市场。2011年2月，赛诺菲完成了对BMP太阳石的收购。

大幅投资工业建设、满足中国市场需求
赛诺菲目前在中国拥有六家生产基地，包括北京制药工厂、杭州制药工厂、杭州赛诺菲民生健康药业工厂、南昌梅里亚动物保健工厂、深圳赛诺菲巴斯德疫苗工厂、以及唐山健康药业工厂。

完善的研发架构、双赢的研发合作模式
在中国，赛诺菲具有从药物靶点发现到后期临床研究的整体研发实力。集团在上海设有中国研发中心和亚太研发中心，并在北京和成都分别设有研发机构。自2008年以来，赛诺菲与中国权威科研机构开展了10多项战略合作，在癌症、干细胞、糖尿病和老年疾病等前沿研究领域探索创新药物

依托于强劲的研发能力和多领域领先水平的广泛的医药产品资源，公司在中国的市场份额不断攀升，公司规模不断扩大，飞速发展的业务给了我们与更多优秀人才合作的机会。

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