Manager, safety operations 北京

月薪： 2-3.5万/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： descriptionSAFETY MANGEMENT & REPORTING: Key responsibility is to ensure that systems and processes are available for collection (initial and follow-up), review, reporting and reconciliation of Adverse Events (AEs), Adverse Events combined with Product Quality Complaints (AE+PQCs) and pregnancy reports obtained through the following sources: spontaneous, solicited, clinical trials, data generating activities, local Regulatory Authorities (RAs) and all other potential sources. Manage and maintain active involvement in day-to-day AE reporting as applicable. (case registry, compliance with global organization requirements). Accountable internally for ensuring that the LOC meets procedurally defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.PHARMACOVIGILANCE SERVICE PROVISION: Perform contract review and maintain oversight to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary.Coordinate the provision of support for third party safety agreements with PV implications at the local level and ensure the PV agreement is implemented locally, as appropriate. Ensure PV inspection readiness on the LOC level at all times. Assist inspectors / auditors; support document requests.PEOPLE MANAGEMENT (if applicable): Ensure proper documented training on drug safety reporting responsibilities of Janssen LOC personnel and maintenance of awareness of drug safety reporting in general.(safety management and reporting). Manage and direct local safety staff providing coaching and feedback, if applicable.PROCESSES & REGULATIONS: Ensure implementation of Global and Cross-Pharma Procedural Documents as applicable and/or write, validate and implement the Local Implementation Memos (LIM) for Regional / International PV Standard Operating Procedures/Working Practices and verify adherence. Ensure awareness of changes in regulations which may have an impact on PV activities and responsibilities. Evaluate the impact on local processes and inform the appropriate global and regional groups (i.e. QPPV offices and IPV Regional Heads) of any changes to local laws and regulations regarding PV.QualificationEducation/training background:o Bachelor or higher education of medicine/pharmacology. Knowledge/skills:o Master and understand the local regulations and J&J GMS requirements on drug safetyo Master and understand GCPo Medical and pharmaceutical knowledgeo Talent development experience. Work experiences:o At least 5-7 years’ experience on PV/medical/clinical in multinational pharma Competencies:o Keen insight and quick response to national and global PV related regulation updates and PV related development trendso Strong leadershipo Ability of project management. Others: Fluent spoken and written English, CET-6 职能类别： 药品生产/质量管理

联系方式

北京市朝阳区建国路77号华贸中心写字楼

公司信息

公司简介(中文) 恢复为 “成立于1985年的西安杨森制药有限公司（“西安杨森”）是中国最大的合资制药企业之一，也是中国改革开放以来进入中国的最早一批制药公司之一，其总部位于北京的中央商业区。西安杨森是强生公司的一员。从创立之初，西安杨森就致力于引进和生产许多创新产品和高质量产品。西安杨森一直致力于投资未来，计划增加在生物制品、心脏病学、风湿病学和泌尿科学领域的新系列产品。西安杨森致力于利用这些新药改善中国患者的医疗保健状况。 本着公司信条和关爱精神，西安杨森一直是活跃的企业公民，在医药、公共卫生、药物研发领域和企业社会责任方面从事了五十多项合作项目。例如，西安杨森与中国卫生部国际卫生交流与合作中心合作创立了“吴阶平医学研究奖和保罗•杨森药学研究奖”，旨在鼓励医药学领域的工作者不断创新。在过去的17年中，共计305名杰出医药学工作者在45个专业领域获得了该奖项，他们在科研领域做出了大量有价值的创新。 此外，西安杨森也被誉为培养制药行业人才的摇篮。1999年，西安杨森被财富杂志（中文版）评选为“中国最受敬仰的十大外资企业之一”。2005年，西安杨森被中国中央电视台评选为“***雇主”，并且分别在2008年、2009年和2010年获得了“中国大学生***雇主奖”。 目前西安杨森所有的招聘信息仅通过前程无忧，智联招聘和猎聘网进行发布，任何在非上述三家招聘网站看到的信息均非西安杨森正式发布。为避免对您的合法权益造成伤害，请务必通过正规渠道投递简历。 2013年，强生在西安高新区投资兴建强生全球供应链先进的生产基地，该项目建设目前已正式启动。新生产基地占地267,000平方米，将取代西安杨森在西安新城区现有的生产基地，成为强生供应链在亚洲的创新枢纽，从而更好地满足中国和其他新兴市场不断增长的需求。新的生产基地将采用世界***的制造技术和先进的质量体系，并引进集电子批号记录和数据存储于一身的全自动化配方生产操作系统以及先进的德国进口生产工艺设备。

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