Manager, Drug Safety Science

The Position

Primary Purpose of Job (Job Summary) 主要工作目标（岗位简介）

• Ensures that collection, reporting and handling of safety information associated with Roche products is performed according to global Roche and local regulatory requirements.

确保依照全球罗氏和当地法规要求收集、报告和处理罗氏产品相关的安全性信息。

• Demonstrates independence and high competence in the conduct of all safety science responsibilities.

在执行所有安全科学职责方面表现出独立性和较高的能力.

• Maintains oversight of the management of safety information, safety risk management and all other pharmacovigilance (PV) activities, ensuring PV medical compliance (Roche policies and procedures, global and local regulatory requirements) and inspection readiness

对安全性信息管理、安全性风险管理和所有其他药物警戒 (PV) 活动进行监督，确保 PV 活动的合规性（符合罗氏政策和程序、全球和当地法规要求）和做好迎检准备。

• Design and execute safety strategy efficiently to optimize all safety activities in Medical. Provide supports to safety evaluation activities, contribute consultant to medical projects, and ensure timely safety communication. Contribute to safety science deliverables required to maintain license, labeling document, and NDA et al.

有效地设计和执行安全策略，以优化医学部所有安全性相关活动。 为安全性评价活动提供支持 、为医学部相关项目从患者安全角度提供建议，确保及时的安全性沟通。为维护许可证、产品说明书和 新药注册等提供所需的药品安全科学相关数据和材料。

• Maintain relationship with internal (local and global) and external parties such as authorities for update and alignment of regulation and collaboration of safety matters.

保持与内部（包括中国和全球）和外部各方的关系，例如和监管机构之间关于法规更新以及安全事项的沟通与合作。

• Own PV business processes and ensure knowing well about Roche product knowledge.

主导相关的 PV 业务流程并掌握罗氏相关产品知识. • Independently manage safety responsibilities, mentor junior members in the team and take the lead on more complex deliverables and projects requiring more coordination and insights, such as lead the safety process development activities and the education platform in PV function
独立管理安全职责，指导团队中的新成员，并领导更复杂的可交付成果和需要更多协调和见解的项目，例如领导建立安全性流程和 内部教育平台的搭建

Principle Roles & Responsibilities / Accountabilities 主要职责/责任 (Major functions of the position) （职位的首要职能）

• Maintains oversight of the management of safety information, safety risk management and all other pharmacovigilance (PV) activities, ensuring PV medical compliance (Roche policies and procedures, global and local regulatory requirements) and inspection readiness. Designing & execution of safety strategy and ensure high quality deliveries.

保持对安全性信息管理、安全性风险管理和所有其他药物警戒 (PV) 活动的监督，确保符合相关规定（罗氏政策和程序、全球和当地法规要求）和做好迎检准备。 确保高质量的设计和执行安全策略。
a) Independently perform proactive safety surveillance and risk management including product safety signal detection & evaluation, risk assessment and safety risk minimization.
独立进行主动的安全性监测和风险管理包括产品的安全性信号检测和评估、风险评估和风险最小化。
– Ensure knowing well about product safety risk management knowledge.
确保掌握产品安全风险管理知识。
– Contribute to development of local RMP and ensures oversight of its implementation in collaboration with relevant staff in accordance with Roche policies and procedures, global and local regulatory requirements.
促进当地 RMP 的制定，并确保按照罗氏的政策和程序、全球和当地法规要求，与相关人员合作，监督 RMP 的实施。
b) Act as a safety expert in the Disease Area Strategy Teams, Design and execute safety strategy efficiently to optimize all safety activities in Medical. Ensuring a unified communication on safety matters. Perform frequent proactive Holistic Safety Review for products, across the span of relevant available safety data information. Reviews are incremental, cumulative and aggregate, to include the body of safety information available (e.g. clinical, epidemiology, spontaneous, literature & regulatory cases, other scientific data)
作为疾病领域战略团队的安全专家，有效地设计和执行安全策略，以优化医学部的安全性相关活动，并确保就安全性相关沟通的一致性。在可获得的相关安全性数据信息范围内，纳入可用的安全性信息（例如，临床、流行病学、自发报告、文献和监管病例、其他科学数据），对产品进行主动的一定频率的整体安全性审查，进行增量、累积和汇总的审查。
c) Acts independently to manage safety responsibilities on study teams and in activities supporting safety science. Provide safety input to Medical studies by reviewing safety section of study document. Ensures appropriate safety reporting processes are in place at affiliate level and if applicable, described in relevant local documents, for global and local interventional clinical trials, Non-interventional Studies (NISs), Post Authorization Studies(PASS/PAES), Pre-Approval and Post Trial Access Programs and Compassionate Use in accordance with Roche policies and procedures, global and local regulatory requirements.
独立的在研究团队内承担临床试验中的药品安全相关职责。通过审核研究文件的安全性内容为医学研究提供药物安全相关意见。确保适当的安全性报告程序在当地的实施，在全球和当地的干预性临床试验、非干预性研究 (NIS)、上市后研究 (PASS/PAES)、批准前或试验后用药项目，同情用药项目中有相应的描述（如适用），并符合罗氏政策和程序、全球和当地监管要求。
d) Provides safety related information to global teams for the preparation of Aggregate Reports, where applicable. Ensures preparation of Aggregate Reports for local products, where applicable, in collaboration with local Drug Regulatory Affairs (e.g. license renewal).
向全球团队提供安全性相关信息，以编写汇总报告（如适用）。确保在适用情况下，与当地药品法规事务部合作，编写当地产品的汇总报告（例如许可证更新）。
e) Provides the clinical safety teams and/or QPPV office and external key stakeholders (as applicable) with all relevant safety information.
向总部安全科学团队和/或 QPPV 办公室以及外部主要利益相关者（如适用）提供所有相关安全性信息。
f) Provide safety input to local labels generation and maintenance. Ensures awareness of and contributes as applicable to local safety label updates. Contributes to the implementation of PV commitments, when applicable.
为本地说明书的制定和维护提供安全性意见。确保了解并参与当地安全性标签更新（如适用）。在适用的情况下，参与到药物警戒相关承诺的执行。
g) Maintains oversight of the Direct Healthcare Professional Communication (DHPC), Dear Investigator Letter (DIL) & To Whom It May Concern Letter (TWIMCL) processes.
保持对医疗保健专业人员告知函 (DHPC)、致研究者函 (DIL) 和致相关人士函 (TWIMCL) 过程的监督。
h) Work with the relevant SRPL functions for responses to safety queries and the solution of high impact cases from China regulatory agency, media, patients, medical community and investigators. Ensures that management of safety queries, other significant safety issues and if applicable, local/global crises is performed according to global Roche and local regulatory authority requirements.
与上海罗氏内部的相关职能部门合作，以回应来自于中国监管机构、媒体、患者、医学界和研究者的关于安全性质疑并解决高影响病例。确保按照全球罗氏和当地监管机构的要求，对安全性问题、其他重大安全性问题和当地/全球危机（如适用）进行管理。
i) Proactively supports the Local Safety Responsible in all safety evaluation activities.
Represent Drug Safety Science with business process owners on processes executed by Drug Safety Science. Generate and maintain local SOPs taking into account the global SOPs and local regulation.
积极主动地支持当地药物警戒负责人进行所有安全评估活动。
在由药品安全科学执行的流程中代表药品安全科学的业务流程负责人。根据全球 SOP 和当地法规制定和维护当地 SOP。
k) Engagement in audit & inspection readiness and support. Act as SME for affiliate PV-related CAPAs. Provision of data to project managers for metrics and activity tracking.
参与内审和检查的准备和支持。担任分支机构药物警戒相关纠正及预防措施的相关专家。向项目经理提供数据，以便对相关指标进行衡量和对活动进行跟踪。
l) Provides input for the relevant service provider Functional Oversight Responsible to ensure that PV requirements are met.
通过向药物警戒供应商监督负责人提供建议来确保符合药物警戒要求。
m) Support the team leader in all Safety Science activities.
支持药物警戒负责人进行所有安全科学相关活动。

• Enhance internal and external collaboration:
• 加强内外部合作：

a) Independently manage safety responsibilities, mentor junior members in the team and take the lead on more complex deliverables and projects requiring more coordination and insights, such as lead the safety process development activities and the education platform in PV function 独立管理安全职责，指导团队中的新成员，并领导更复杂的可交付成果和需要更多协调和见解的项目，例如领导建立安全性流程和 内部教育平台的搭建
b) Serve as interface and build up internal cross-functional partnership with focus on the commercial, regional and global counterparts.
作为安全部门的联络人建立公司内部的协作机制，着重在与业务部门，区域以及总部的相关部门。
c) Build active connection and support team member in discussion with authority for update and alignment of regulation, relevant RA commitment.
在当地的法规更新、执行药物警戒相关要求中，与当地监管部门进行交流，建立积极的联系并支持团队成员完成相应的任务。
d) Keeps up to date with local regulations and acts as the nominated person for PV if required by local regulations.
了解当地法规的最新更新，并按当地法规要求担任 PV 的指定人员。

• Compliance adherence:
• 坚持合规：

Implement ICH GCP, GVP, local regulations and Roche SOP to ensure all medical initiatives in line with relevant SOPs and codes
执行 ICH GCP、GVP、地方性法规和罗氏 SOP，以确保所有医学相关活动符合相关 SOP 和规范

Qualification and Experience 能力与经验
Education/Qualifications教育程度/所获资格证书

• Master Degree in Clinical Medicine or above

医学硕士及以上

• Clinical experience will be preferred

有临床实践经验者优先

• Other life sciences background with significant experience in Drug Safety (especially Safety Science) can be acceptable if approved by LSR on a case by case basis, provided medical oversight is ensured.

具有药物安全（尤其是药物安全科学领域）方面丰富经验的其他医疗保健人员，需经过当地药物警戒负责人逐例批准，且在确保其能行使其医学监督的职责的前提下，可以担任此职位。

• Appreciation of GxP and regulatory policies.

对GxP以及法规了解

• MNC pharmaceutical company experience in medical/PV related role will be preferred

MNC制药公司有医学药物警戒相关工作经验者优先考虑
Leadership Competencies领导者胜任力

• Ability to drive the delivery of commitment in a matrix team

在团队中推动目标达成的能力
Job Required Competencies岗位所需胜任力

• Good Knowledge:

知识掌握
– Drug safety knowledge and relevant TA/disease area
药物安全性知识和相关疾病领域知识
– Drug safety relevant regulations (ICH,EMA,FDA—if relevant—and local regulation)
药物安全性相关法规（ICH、EMA、FDA（如相关）和当地法规）
– Medical knowledge of Roche products and relevant TA/disease area
罗氏产品和相关疾病领域的医学知识
– Medical terminology in English—verbal and written
英文医学术语-口头和书面

• Good communication skills and presentation skills

良好的沟通和演讲技巧

• Good understanding of GVP, GCP and other clinical study process within the pharmaceutical sector

了解 GVP、GCP 和制药行业的临床研究流程

• Good organization and planning skills

良好组织和规划技能

• Strategic thinking

战略性思维

• Influencing skills. Ability to motive the team members and other functions working towards shared goals.

影响技能。能够激励团队成员和其他职能，以实现共同的目标。

• Ability to work independently and cooperate and interact well in a multifunctional team setting

独立工作能力在一个多功能的团队环境中进行合作和良好的互动

• Relevant working experience: at least 3-5 years of clinical and/or DS experience

相关工作经验：至少有 3-5 年临床和/或药物安全相关经验

• Language: Fluency in English and Chinese, written and verbal.

语言：中英文，书面和口头流利。

• Computer skill: Computer literacy, usage of MS Office software, web-based systems and databases.

计算机技能：计算机知识，使用 MS Office 软件、基于 web 的系统和数据库。

• Roche Core Competencies

罗氏核心竞争力

• Proven ability to demonstrate Roche Values and Leadership Commitments

证明有能力证明罗氏的价值观和领导承诺
The statements made here are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.
此处的声明旨在描述分配给此工作的人员所执行工作的一般性质和级别。并未穷尽分配给本岗位人员所需的所有责任、职责和技能的所有清单

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