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Takeda Pharmaceutical Company Ltd. Senior Manager, Global Drug Safety, Greater China in Shanghai, China

Position Title 职位名称 : Senior Manager, Global Drug Safety, Greater China

Entity 公司名称: Baxalta Bioscience (Shanghai) Co.,Ltd. 百深生物科技(上海)有限公司

Division 业务部门: Drug Safety药物安全部

Report to 汇报对象: JAPAC Drug Safety Director亚太药物安全总监

Location 工作地点: Shanghai, China上海,中国

Responsibilities: 工作职责

Sub-Region Lead of Drug Safety (China/Taiwan/Hong Kong/Macao) is responsible for set up, maintain and oversee an efficient pharmacovigilance (PV) system and overseeing the clinical study and post-market safety function of the applicable affiliate offices in compliance with local regulations and company policies.

药物安全区域负责人(中国/台湾/香港/澳门)负责在区域内建立、维护和监督有效的药物警戒体系, 监督区域内临床研究和上市后药物安全活动遵从当地法规和公司制度。

The Sub-Region Lead of Drug Safety will be the primary point of contact for applicable Country office safety enquiries, issues and support and will monitor the systematic collection, documentation, submission, reconciliation and timely communication of drug safety information pertinent to all local marketed products and those clinical studies with local safety responsibilities.

药物区域药物安全负责人是安全性询问、问题和支持的主要联系人,并且负责监督系统性的收集、记录、递交、核对和及时交流关于在当地上市和临床研究的药物安全性信息。

Set up, maintain and oversee a local efficient pharmacovigilance system建立、维护和监督当地有效的药物警戒系统 Monitor making local AE and safety information awareness training plan and implementation监督制定当地不良事件和安全性信息认知培训计划和执行情况 Set up process of collecting safety information from relevant sources建立从不同途径收集药物安全性信息的流程 Monitor to report individual cases to Global Drug Safety (GDS) 监督向药物安全总部传递的个案报告 Ensure timely to submit individual cases as well as line listing to Regulatory Authority 确保及时向监管部门报告个案及行列表报告 Ensure timely to prepare and submit periodic safety updating report (PSUR) 确保及时准备并递交定期安全性更新报告 Organize Death cases/batch case Investigation 组织死亡病例/群体事件调查 Be responsible for Drug safety intensive monitoring 负责药物安全重点监测 Support local product registration and license maintenance activities支持产品注册以及注册证更新活动 Communication with Regulatory Authorities与法规监管部门的沟通 Collaborate with GDS and local cross-functional team in development and implementation of local Risk Management Plan通过与总部及当地跨部门同事合作制定和确保执行当地的风险管理计划 Master local Pharmacovigilance related regulations maintaining knowledge of them with particular reference to any deviations from standard ICH / EU definitions, requirements any new changes with impact on the PV-system and communicate accordingly 熟悉当地药物警戒相关法规,识别其中与ICH和欧盟法规有不一致的内容及时进行交流并要求药物警戒系统相应的更新。 Support GDS in the development of the PSMF annexes 支持总部的药物警戒系统管理文件附件更新 Assist with audit preparation and lead local authority pharmacovigilance inspection if required 协助审计和负责当地监管机构稽查的准备工作 Support update of safety part in local package insert支持当地说明书中安全性内容的更新

Qualifications: 职位要求

Skills required技能要求:

  • Fluent in oral and written English英语口语及书写流利

  • Excellent communication skills and cultural awareness良好的沟通 技巧和文化意识

  • Experience of working with quality management processes and compliance monitoring有质量管理和合规监督经验

  • Ability to work independently, take initiative and complete tasks to deadlines能够独立工作,积极主动并在时限内完成工作

  • Ability to independently resolve problems and conflicts有独立解决问题和冲突的能力

  • Good interpersonal, analytical and organisational skills有良好的人际互动、分析和组织能力

  • Must be able to effectively present complex information能够有效的介绍复杂的信息

Knowledge & education required教育背景要求

  • Medical or Pharmacy background, bachelor or above医学或药学背景,本科或以上学历

  • Expert knowledge of China PV regulation and international regulation对中国及国际药物警戒相关法规有良好的专业知识

Experience required经验要求

  • More than 3 years working experience in Pharmacovigilance of international pharmaceutical company在跨国公司的药物安全部门有超过三年的工作经验

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

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