Associate Manager, Safety Operations & Compliance (职位编号：36846134)社

面议

市辖区本科及以上2年及以上

发布时间：2023-09-06

职位描述

I Management of Individual Case Safety Report (ICSR) from all relevant sources (solicited andunsolicited sources) 所有相关来源的个案病例安全性报告 (ICSR) 管理（征集和非征集来源）II Local Signal Detection for local products, where applicable, in collaboration with SafetyScience 在适用的情况下，与药物安全科学团队合作进行本地产品的本地信号检测，III Program Oversight and PV Approver for Market Research and Patient Support Programs(MAPs) 市场调研和患者支持项目 (MAP) 的 项目监管和 PV 批准Ensures appropriate safety reporting processes are in place at affiliate level and, if applicable, describedin relevant local documents, for Market Research and Patient Support Programs (MAPs) in accordancewith Roche policies and procedures, global and local regulatory requirements.确保罗氏中国实施适当的安全性报告程序。在适用的情况下，根据罗氏政策和程序、总部和当地法规中对市场研究和患者支持项目 (MAP)的要求，在相关当地文件中描述。Ensures that a PV Approver for Market Research and Patient Support Programs (MAPs) is in place.确保指定市场研究和患者支持项目 (MAP) 的 PV 批准人。IV Roche Internal Safety Reporting Oversight 罗氏内部安全性报告监督Associate Manager, Safety Operations & Compliance_V2.0_1 Jun 2020 Page 2 of 4Provide oversight on internal stakeholders to ensure all safety information associated with Roche Productshas been collected and reported as appropriate, which include but not limited to the following sources:对内部相关报告方进行监督，以确保与罗氏产品相关的所有安全性信息都已被合适的收集并报告，包括但不限于以下来源：– Safety Representatives 医药代表– MI Atlas 医学信息– Technical complaints/counterfeit related issues 质量投诉/假药相关问题– CRM, Roche owned digital or media and other sources 客户管理系统、罗氏发起的数字或媒体平台和任何其它来源V Management of Aggregate Reports 汇总报告的管理？ Provides safety related information to global teams for the preparation of Aggregate Reports, whereapplicable.在适用时，向总部相关部门提供用于准备汇总报告的相关的安全性信息。？ Ensures preparation of Aggregate Reports for local products or as per local regulatory requirements,where applicable, in collaboration with Safety Science.确保与药物安全科学团队合作，准备本地产品的汇总报告、或当地法规要求的汇总报告？ Submit of PSURs/PBRERs and other Aggregate Reports to local regulatory authorities in accordance withRoche policies and procedures, global and local regulatory requirements.根据罗氏的政策和程序、总部和当地监管要求，向当地监管机构提交 PSUR/PBRER 和其它类型的汇总报告。VI Contract Review and PV Agreements 合同审阅和药物警戒协议？ Reviews contracts and provides input on necessary clauses/sections/wording for ensuring PV compliance.**合同，并提供相应的条款/章节/措辞，以确保药物警戒合规。？ Reviews and approves the safety clauses/sections/wording in local commercial agreements. Ensurespreparation and execution of PV Agreements.审阅并批准当地商业协议中的安全性相关条款/章节/措辞。确保药物警戒协议的准备和执行。？ Maintains oversight of PV activities as outlined in the PVA for local commercial agreements.按照当地商业协议签署的药物警戒协议中的规定，对药物警戒活动进行监督。VII Monitoring and Oversight of Service Provider Management/Outsourcing process 供应商管理/外包过程的监测和监督？ Provides input for the relevant service provider Functional Oversight Responsible (FOR) to ensure that PVrequirements are met.为相关供应商的部门监督负责人提供建议，以确保符合相关药物警戒的要求。？ Acts as a FOR for GVP service providers, as applicable.在适用的情况下，作为药物警戒供应商的部门监督负责人。VIII Labelling and PV Commitments 药品说明书和药物警戒承诺？ Ensures awareness of and contributes as applicable to local safety label updates.确保知晓当地药品说明书的更新，并根据需要为其更新提供建议。？Associate Manager, Safety Operations & Compliance_V2.0_1 Jun 2020 Page 3 of 4？ Contributes to the implementation of PV commitments, when applicable.在适用的情况下，协助履行药物警戒承诺。IX PV Quality 药物警戒质量？ Provides input on the PV KPIs for discussion, including at formal affiliate Management Reviews.提供关于药物警戒相关主要指标(KPI)的建议或意见用于讨论，包括正式的公司层面的管理审评。？ Act as SME (Subject Matter Expert) for any affiliate PV-related CAPAs.作为任何公司药物警戒相关CAPA(改正及预防措施)的专家。？ Review of the Safety Operations & Compliance related local process to ensure alignment with Roche SOPsand China regulations.审核药物安全运营&合规相关的当地流程，以确保与罗氏SOP 及中国法规保持一致。X Regulation intelligence 法规？ Keeps up to date with local regulations and share the impact assessment of new or updated localregulation with relevant global team, when applicable.确保与当地法规保持一致并且在适用的情况下，与相关的总部部门分享关于新法规或法规更新的评估结果。XI Support (Senior) Manager, Safety Operations & Compliance in all Team Activities 支持（高级）药物安全运营和合规经理的其它团队活动？ Supports in all team activities including audits and regulatory inspections.为团队所有活动提供支持，包括审计和法规部门的检查。？ Provides safety support and represent team to engage stakeholders to ensure better communication.提供安全性支持，并代表团队相关部门进行对接以确保良好的沟通。？ Support the safety relevant project with industry peers.支持与行业内同行进行的安全性项目。？ Supports in interacting with local Health Authorities.在与当地药监机构的沟通中提供支持。Qualification and Experience 能力与经验Education/Qualifications 教育程度/所获资格证书Bachelors or Master Degree, major in healthcare related field (Health care professional, i.e., Clinical medicine,Pharmacist, Nurse.) or in bioscience preferred.学士或硕士学位，在医疗保健相关领域（医疗卫生专业，如临床医学、药剂师、护士）或生物科学专业优先。Leadership Competencies 领导者胜任力Demonstrated leadership in cross-functional communication, project management, etc.已证明的在跨职能团队的沟通、以及项目管理方面表现出的领导力。Job Required Competencies 岗位所需胜任力？ Relevant working experience: 3-4 years of experience in PV/clinical experience is preferable？Associate Manager, Safety Operations & Compliance_V2.0_1 Jun 2020 Page 4 of 4相关工作经验：3-4 年药物警戒/临床经验优先？ Strategic thinking策略性思维？ Communication skills沟通能力？ Influencing skills影响力？ Language: Excellent written and spoken English and Chinese语言：良好的英文和中文书面和口语表达？ Knowledge on PV knowledge and relevant regulations (ICH, EMA, FDA, NMPA)了解药物警戒知识和相关法规(ICH, EMA, FDA, NMPA)Travel Frequency 出差频率■ <25%

其他要求

招聘人数：1人
职能类别：其他运营推广职位

公司介绍

上海罗氏制药有限公司成立于1994年，是抗肿瘤、抗**、移植等关键领域的市场领导者。在大型跨国药企中，我们率先在中国建成了包括研究、开发、生产、营销等环节在内的完整的医药价值产业链。罗氏中国正向着成为罗氏全球第三个战略中心的目标迈进，以实际行动践行在中国长期发展的承诺。

我们始终以患者为中心，致力于帮助患者从根本上延长生命和改善生活质量。目前，罗氏在华拥有16个产品，覆盖8个治疗领域。我们与**、医疗机构以及非**组织等社会各界多方携手，共同探索创新的合作模式，通过一系列有影响力和可持续的举措惠及更多的中国患者。

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