湖州招聘

Job Responsibilities
The Sr. PV Operation Manager:
- Is recognized as the leader for China PV operation team.
-Ensures that local PV operation activities are performed in compliance with the GPV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of Sanofi products in China
-Support CSH to allocate adequate resources and budget in close collaboration with the local controllers
-Arrange PV training to relevant external and internal staffs, prepare the training materials and maintain the training documentation.
-Works collaboratively with other key stakeholders locally as well as key GPV stakeholders.
-Responsible for data Integrity and audit support related to GPV systems.
-Ensure appropriate liaison with local and national health authorities.
-Ensure PV operation document archiving is aligned with company requirement.
-Ensure all source documents are maintained in accordance with company policy
Organization and Maintenance of PV Operation:
-Maintain the ICSR processing comply with local regulation and company policy
-Monitor ICSR inbound metrics and assign the cases in PV operations team to ensure all safety information handled appropriately
-Implement frequent reconciliation between PV database and inbound database for spontaneous ICSRs
-Implement and track the quality control for safety data process
-Monitor the case processing compliance, implement root cause analysis and CAPA as needed
-Generate monthly ICSR operation report
-Manage the monthly line listing submission
-Ensure case QC activities are performed in compliance with the GPV policies and local SOPs
Periodic safety report management:
-Work with GPV to complete Master Plan Table and local PSR submission plan
-Arrange the PSR translation
-Ensure the compliance and quality of PSR submission to HA
-Implement cause analysis and CAPA for late submission
Local PV System and quality documents management:
-Maintains the PV operation quality documents, including creating and updating quality document, giving training to all PV staffs.
-Monitor continuously in-coming communication to ensure the detection and appropriate management of in-coming PV data (ICSRs and other safety related information) to report them in timely manner to GPV/ Global PV entities and external stakeholders such as HAs, partners
-Screen local scientific / medical literature and forward the relevant abstract/articles to GPV
-Screen and analyze national regulations, and forward any future/new/updated PV regulation (draft or final) to GPV via Regulatory Intelligence unit and Region PV Head
-Participate in the local business continuity plan and after hours’ emergency calls process and holiday coverage arrangement
-Ensure accurate local implementation of global Safety Data Exchange Agreements (SDEAs), when applicable. Secure that for all local Business Partner agreements, requiring safety provisions, a local SDEA or PV Clause is set-up, implemented and maintained as appropriate.
Management responsibilities:
-Manage country PV budget in a cost-effective way to ensure an efficient local PV system in adherence with regulations and company policies
-Provide leadership, mentorship and supervision to PVE (e.g. leading regular team meetings) to ensure transparency and alignment on strategic direction, goals, processes and objectives
-Sets up the appropriate resources and qualification of the team, evaluates team performance and fosters training and personal development by effective talent management and recognition
Vendor Management:
-Initiates local PV outsourcing project, monitor performance of Service Provider, collaborate with global PV colleague to ensure PV outsourcing project to smoothly executive.
-Manager contract/work order with local service provider, monitor the appropriate execution of outsourced activities and take the appropriate measures in case of deviations.
-Ensure the quality and compliance for out-sourced PV operational activities
Give PV operational support on safety related queries:
-Provide appropriate PV operation report, e.g. case line listing, local signal report, OBIEE query report, to support PV Physician answer various PV queries
-Provide quarterly ICSR submission summary to each IA site
-Complete ICSR summary report according to HA requirement
-Generate monthly PV operations report to CSH
Support CSH to complete affiliate monthly PV survey and AMPAR on PV operations activities

职位要求：
Job Requirements:
General
-Excellent Word, Excel, PowerPoint and English skills.
-Good time management skill and people management skill.
-Good communications skill to communicate with internal and external stakeholders.
Competencies
-Excellent knowledge and expertise in project management, Pharmacovigilance and related regulations
-Demonstrate problem solving skills, sense of urgency, especially with respect to enforcing safety rules and global procedures as described in QDs, Operational Manuals and Guidance documents. Capacity to work under pressure
Education
-Pharmacy, Nurse or relevant Master or Bachelor Degree
Experience
-Experience with local pharmacovigilance operation in multinational company is mandatory.
-Experience with project management is highly recommended.
-At least 5 year experience in local pharmacovigilance activities.
-Experience with Regulatory Agency interactions.
在赛诺菲，多样性和包容性是我们如何运作和嵌入核心价值观的基础。我们认识到，要真正挖掘多样性所带来的丰富多彩，我们必须以包容为先导，并拥有一个工作场所，在那里，这些差异可以茁壮成长，并被利用起来，让我们的同事、患者和客户的生活更丰富多彩。我们尊重和颂扬我国人民的多样性、他们的背景和经验，并为所有人提供平等的机会。

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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