富启睿
Asst II PSS
Asst II PSS
发布于 1 天前普通员工/个人贡献者
大连市
初级经验
全职员工
混合式弹性办公
不限
医疗、制药与临床研究
Cro
Meddra编码
临床试验
安全数据库
监管提交
药物警戒
质量管理体系
Ae/Sae处理
患者叙述撰写
AI 估算 · 5k–7k
初级职位，大连CRO公司，薪资在行业中位偏低，但提供稳定的平台和技能积累机会。
职位详情
关于这个职位
该职位主要负责临床安全和药物警戒的辅助工作，包括收集、处理和报告临床试验及上市后的不良事件
您将参与安全数据的录入、追踪和监管提交，确保在规定时限内完成高质量的安全报告
适合具备医药背景或相关经验的初级人才，是进入药物安全领域的良好起点
最低要求
Non-Degree or 1-2 years of Safety experience or relevant experience*
Associate degree or 6 months to 1 year of Safety experience or relevant experience*
BS/BA with 0-6 months to 1 year of Safety experience or relevant experience*
MS/MA with 0-6 months of Safety experience or relevant experience*
PharmD with 0-6 months of Safety experience or relevant experience*
For PharmD, a one-year residency of fellowship can be considered as relevant experience. To be considered in lieu of experience, Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area
Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
* Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Speaking: English and local language.
Writing/Reading: English and local language.
工作职责
Assist in the processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to:*
Maintenance of adverse event tracking systems.
Set-up and maintenance of project files, and central files for documentation.
Assist with the reporting of ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines.
Ensure all incoming Adverse Event (AE)/ Serious Adverse Event (SAE) reports are appropriately logged into the departmental tracking application and forwarded to the centralized mailbox.
Assist with processing of the adverse events, including but not limited to:*
Data entry of safety data onto adverse event tracking systems.
Write patient narratives and code adverse events accurately using MedDRA (for Marketed products, if applicable).
Assist in the listedness assessment against appropriate label (for Marketed products, if applicable).
Generate queries for its collection of missing or discrepant information in consultation with medical staff, if needed.
Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines.
Maintenance of adverse event tracking systems
Assist with peer/quality review of processed reports and support with trends and actions as needed.
Assist in the reconciliation of databases, as applicable.
Assist in the maintenance of files regarding adverse event reporting requirements in all countries.
Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate.
Prepare and support coordination of safety study files for archiving at completion of projects.
Arrange and schedule internal and/or external meetings/teleconferences.
Train and mentor, the PSS Assistants or peers in their day-to-day activities.
Build and maintain good PSS relationships across functional units.
Ensure compliance of operations with governing regulatory requirements and applicable study/project specific plans.
Assume responsibility for quality of data processed. Provide administrative support to PSS personnel.
All other duties as needed or assigned.
AI 洞察
优缺点分析
优点
- 进入药物警戒领域的好机会，无需相关经验也可培养
- 跨国CRO平台，项目类型丰富，积累全球合规经验
- 支持远程办公，工作安排相对灵活
- 团队氛围好，有导师和培训机制
- 薪资初期偏低，成长空间依赖个人主动学习
- 适合对药物安全感兴趣、注重细节、愿意从基础做起并长期发展的求职者
缺点 / 挑战
- 工作内容重复性较高，需要高度细心和耐心
- 需同时处理多个项目，时间压力较大
角色解读
- 可向高级PSS分析师或团队负责人发展，积累更多项目经验
- 在CRO行业内转向临床运营、数据管理或监管事务等相邻岗位
- 通过考证和培训深化药物警戒专业知识，成为行业专家
- 负责临床安全数据的录入、追踪和报告，确保不良事件及时准确处理
- 使用MedDRA编码不良事件，撰写患者叙述，协助监管提交
- 维护安全数据库和项目文件，支持团队的质量审查和一致性核对
- 培训新同事，参与内外部会议，确保合规运营
- 熟悉药物警戒流程和不良事件处理规范
- 具备用中英文读写和沟通的能力，处理全球项目
- 注重细节，具备逻辑思维和数据分析能力
- 熟练使用MS Office和Windows，适应数据库操作
申请策略
- 突出对CRO行业和药物安全的热情，强调学习能力和稳定性
- 申请时如有安全实习或相关项目经历可单独列举
- 突出医药、生命科学或护理相关教育背景
- 如有安全数据处理、医学写作或监管经验务必详细说明
- 强调中英文沟通能力和团队协作案例
- 展示对细节和合规的重视，例如曾处理过大量文档或数据
- 了解MedDRA编码基础知识，可通过在线课程学习
- 熟悉ICH-GCP和药物警戒相关法规
面试指南
- 使用STAR方法（情境-任务-行动-结果）回答行为问题
- 对于技术问题，展示对流程的理解，并强调合规意识和团队协作
- 准备中英文双语答案，展现语言能力
- 你如何处理不良事件报告中的缺失信息？
- 请描述一次你注重细节并发现关键错误的经历
- 你如何管理多任务和优先级？
- 你对药物警戒和ICH-G7/GCP有什么了解？
- 请用英文简要介绍你自己
职位点评
66
综合评分
初级药物警戒岗位，成长性中等，薪资偏低，可远程办公。
从薪资福利、成长空间、工作节奏和岗位方向综合评估，方便横向比较。
更适合这类人
适合重视技能积累和行业入门，对薪资要求不高的求职者。
表现最好
成长发展
相对薄弱
薪资福利
薪资福利55
成长发展75
工作生活70
使命价值65
薪资福利
55较低
薪资水平偏低，福利信息不明，仅提供基本薪酬。
薪资信号未披露（AI估算：4K-7K/月）
成长发展
75中等
职位提供安全领域入门机会，有导师制，但晋升路径不明确。
技术前沿传统/成熟技术
技术栈AE/SAE处理、MedDRA、安全数据库、监管提交
成长机会Train and mentor
业务类型ambiguous
工作生活
70中等
支持远程办公，但工作节奏可能因项目期限而紧张。
工作模式混合式弹性办公
办公地点未明确
加班情况未提及（无法判断）
使命价值
65中等
药物安全对患者有意义，但日常工作偏行政重复。
行业发展稳定成熟行业
社会影响中性/一般
创新程度稳健跟随主流
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