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PV Physician
25-55K/月北京市-北京/硕士及以上/3-5年
刘先生4天前来过
北京科锐国际人力资源股份有限公司
职位详情
Job Purpose 工作目标
Summarizes the job’s
purpose or role and why it exists in the organization
概述工作的目的或角色及其在机构内的价值
Under the supervise of Pharmacovigilance function head, be responsible for the continued safety assessment, evaluation, and risk management of DZ products or product groups in various stages of clinical development.
在药物警戒负责人的指导下，负责迪哲产品或产品组在临床开发各个阶段的持续安全性评估、评价和风险管理。
Review the SAE and SUSAR case report to ensure the quality of accelerated reporting or/and cross reporting.
审查 SAE 和 SUSAR 案例报告，以确保加速报告或/及交叉报告的质量。
Responsible for continuous efficient evaluation of adverse event and all other safety information to predict and manage the safety profile of compounds in clinical development, identify the need for update to reference safety information, and proactive implementation of risk management plan in accordance with regulatory requirements.
负责对不良事件和所有其他安全信息进行持续有效评估，以预测和管理临床开发中的化合物的安全状况，确定更新参考安全信息的需求，并根据监管要求主动实施风险管理计划.
Proactively evaluates the clinical implications of safety data from clinical studies, literature, and other information sources to predict / assess the safety profile of compounds in clinical development to manage the risk to patients.
主动评估来自临床研究、文献和其他信息来源的安全性数据的临床意义，以此预测/评估临床开发中化合物的安全性，管理患者的风险。
Ensure consistent communication of safety topic across all regulatory safety documents.
确保所有监管安全文件中安全主题交流的一致性。
Roles & Responsibility
主要职责
Provides medical input to deliver qualified safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
应内部或监管机构对安全数据的要求，为提供合格的、具有明确结论的安全评估文件提供医学支持。
Be responsible for the Clinical Safety monitoring and management plan. Activities include but are not limited to: definition of identified / potential risks; proposals for mitigation minimization measures; safety go-no go criteria for the clinical program; response to regulatory safety queries and definition of the risk component of the benefit/risk assessment.
负责临床安全监测和管理计划。包括但不限于：定义已识别/潜在风险；缓解最小化措施的建议；临床项目的安全标准；回应监管安全查询，以及收益/风险评估的风险部分的定义。
Leads writing and/or reviews the safety Risk Management Plan.
主导撰写和/或审查安全风险管理计划。
Provides expertise to the medical content of the drug labelling, pharmacovigilance plan and risk minimization activities in the Risk Management Plan.
为药物标签的医学内容、药物警戒计划和风险管理计划中的风险最小化措施提供专业知识。
Represents safety physicians in Clinical Teams and/or Project Teams for developmental and/or marketed products.
代表临床团队和/或项目团队中开发和/或已上市产品的安全医师。
Provides strategic and medical input to project specific safety requirements. Reviews and provides technical input for investigator brochures, protocols, informed consents, final study reports and external data monitoring committees as appropriate.
为项目特定的安全要求提供战略和医学支持。为研究人员手册、方案、知情同意书、最终研究报告和外部数据监测委员会（如适用）提供技术支持和审查。
Provides medical input to regulatory supporting documentation for labelling updates.
为标签更新的监管支持文档提供医学支持。
Present safety information at clinical investigator and commercial meetings.
在临床研究者和商务会议上介绍安全信息。
Provides medical input into Identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals.
为识别和利用适当的信息源和数据库搜索提供医学支持，检索相关数据以评估信号。
Job Requirement 工作要求
Education, Qualification, Work Experience
教育、资质、工作经验
• Medical degree (eg MD, MBBS) 临床医学相关专业
• At least 2 years of clinical experience 2年以上临床经验
• At least 5 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery 5年以上药物开发/患者安全经验（工业界经验主导）并有明确的交付支持
• Drug Development Experience and Application of Disease and TA knowledge 药品开发经验以及疾病治疗领域实践经验
• Excellence in pharmacovigilance丰富的药物警戒相关知识
• Patient Benefit risk assessment患者风险/获益评估
Summarizes the job’s
purpose or role and why it exists in the organization
概述工作的目的或角色及其在机构内的价值
Under the supervise of Pharmacovigilance function head, be responsible for the continued safety assessment, evaluation, and risk management of DZ products or product groups in various stages of clinical development.
在药物警戒负责人的指导下，负责迪哲产品或产品组在临床开发各个阶段的持续安全性评估、评价和风险管理。
Review the SAE and SUSAR case report to ensure the quality of accelerated reporting or/and cross reporting.
审查 SAE 和 SUSAR 案例报告，以确保加速报告或/及交叉报告的质量。
Responsible for continuous efficient evaluation of adverse event and all other safety information to predict and manage the safety profile of compounds in clinical development, identify the need for update to reference safety information, and proactive implementation of risk management plan in accordance with regulatory requirements.
负责对不良事件和所有其他安全信息进行持续有效评估，以预测和管理临床开发中的化合物的安全状况，确定更新参考安全信息的需求，并根据监管要求主动实施风险管理计划.
Proactively evaluates the clinical implications of safety data from clinical studies, literature, and other information sources to predict / assess the safety profile of compounds in clinical development to manage the risk to patients.
主动评估来自临床研究、文献和其他信息来源的安全性数据的临床意义，以此预测/评估临床开发中化合物的安全性，管理患者的风险。
Ensure consistent communication of safety topic across all regulatory safety documents.
确保所有监管安全文件中安全主题交流的一致性。
Roles & Responsibility
主要职责
Provides medical input to deliver qualified safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
应内部或监管机构对安全数据的要求，为提供合格的、具有明确结论的安全评估文件提供医学支持。
Be responsible for the Clinical Safety monitoring and management plan. Activities include but are not limited to: definition of identified / potential risks; proposals for mitigation minimization measures; safety go-no go criteria for the clinical program; response to regulatory safety queries and definition of the risk component of the benefit/risk assessment.
负责临床安全监测和管理计划。包括但不限于：定义已识别/潜在风险；缓解最小化措施的建议；临床项目的安全标准；回应监管安全查询，以及收益/风险评估的风险部分的定义。
Leads writing and/or reviews the safety Risk Management Plan.
主导撰写和/或审查安全风险管理计划。
Provides expertise to the medical content of the drug labelling, pharmacovigilance plan and risk minimization activities in the Risk Management Plan.
为药物标签的医学内容、药物警戒计划和风险管理计划中的风险最小化措施提供专业知识。
Represents safety physicians in Clinical Teams and/or Project Teams for developmental and/or marketed products.
代表临床团队和/或项目团队中开发和/或已上市产品的安全医师。
Provides strategic and medical input to project specific safety requirements. Reviews and provides technical input for investigator brochures, protocols, informed consents, final study reports and external data monitoring committees as appropriate.
为项目特定的安全要求提供战略和医学支持。为研究人员手册、方案、知情同意书、最终研究报告和外部数据监测委员会（如适用）提供技术支持和审查。
Provides medical input to regulatory supporting documentation for labelling updates.
为标签更新的监管支持文档提供医学支持。
Present safety information at clinical investigator and commercial meetings.
在临床研究者和商务会议上介绍安全信息。
Provides medical input into Identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals.
为识别和利用适当的信息源和数据库搜索提供医学支持，检索相关数据以评估信号。
Job Requirement 工作要求
Education, Qualification, Work Experience
教育、资质、工作经验
• Medical degree (eg MD, MBBS) 临床医学相关专业
• At least 2 years of clinical experience 2年以上临床经验
• At least 5 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery 5年以上药物开发/患者安全经验（工业界经验主导）并有明确的交付支持
• Drug Development Experience and Application of Disease and TA knowledge 药品开发经验以及疾病治疗领域实践经验
• Excellence in pharmacovigilance丰富的药物警戒相关知识
• Patient Benefit risk assessment患者风险/获益评估
任职要求
无
薪资结构
无
其他信息
职能类别：医学经理/专员
职位性质：全职
招聘人数：1
工作地点：
- 1 北京市-北京
公司信息
迪哲医药
- 无
- 无
- 医药辅料
- 上市公司
- 不需要融资
知名生物药企目前已上市，产品管线丰富，产品以肿瘤为主
