赛纽仕
Safety & PV Specialist I
Safety & PV Specialist I
发布于 2 天前普通员工/个人贡献者
大连市
中级经验
全职员工
仅现场办公
本科
医疗、制药与临床研究
Gvp
Ich Guidelines
Icsr
Meddra
Microsoft Office
AI 估算 · 8k–12k
大连初级药物警戒岗位，CRO行业通常薪资中等偏上，硕士学历和一年经验对应此范围。
职位详情
关于这个职位
作为一名 Safety & PV Specialist I，你将加入全球领先的医疗健康服务组织赛纽仕，主要负责药物警戒数据的收集、处理和报告
你将操作安全数据库，进行医学编码（MedDRA）、撰写病例叙事，并确保符合GCP、GVP等法规要求
这是一个在药物安全领域积累专业经验的绝佳机会，适合细心、严谨且对患者安全有热情的求职者
最低要求
Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job.
At least one year of experience in pharmacovigilance related projects.
Working proficiency in English, with the ability to read, understand, and communicate safety-related information.
Safety Database systems and knowledge of medical terminology required.
Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance.
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet.
Ability to work independently and in a team environment.
Excellent communication and interpersonal skills, both written and spoken.
Good organizational skills with proven ability to prioritize and work on multiple tasks.
Detail oriented with a high degree of accuracy and ability to meet deadlines.
工作职责
Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
○ Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability.
○ Enters data into safety database.
○ Codes events, medical history, concomitant medications, and tests.
○ Compiles complete narrative summaries.
○ Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
○ Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
Maintains safety tracking for assigned activities.
Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.
Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
Manual recoding of un-recoded product and substance terms arises from ICSRs.
Identification and management of duplicate ICSRs.
Activities related to SPOR / IDMP.
Quality review of ICSRs.
Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.
Fosters constructive and professional working relationships with all project team members, internal and external.
Participates in audits as required/appropriate.
Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
优先资格
Experience handling medical devices preferred, including product complaint identification, analysis, categorization, investigation support, and complaint handling activities.
AI 洞察
优缺点分析
优点
- 进入全球领先CRO，接触国际药物安全项目，积累专业经验
- 公司提供明确的职业发展路径和培训支持，如技术培训、导师制度
- 药物安全领域需求稳定，法规要求严格，岗位具有长期发展前景
- 适合细心、有条理、对药物安全有热情，并希望在全球CRO中稳步发展的求职者，尤其适合有生命科学背景的应届生或初级从业者
缺点 / 挑战
- 工作内容高度重复且需极高准确性，处理大量数据可能较为枯燥
- 严格的时间线和法规要求可能带来一定压力，需要适应严格SOP
- 对英语能力要求较高，需频繁阅读和撰写英文报告
角色解读
- 初级专员可向资深PV专员或团队负责人发展，积累更多项目和法规经验
- 未来可转向药物安全评估、风险管理或医疗事务等方向
- 在大型CRO中，有机会参与全球项目，提升跨文化协作能力
- 负责接收、处理和跟踪个例安全报告（ICSR），确保数据准确完整
- 使用MedDRA进行医学编码，包括不良事件、病史、合并用药等
- 撰写病例叙事摘要，并协助生成快速报告提交给监管机构
- 参与文献筛查、药物编码、词典维护，以及SPOR/IDMP相关活动
- 需要扎实的药物警戒知识，熟悉ICSR处理流程和法规要求（GCP、GVP）
- 熟练操作安全数据库，掌握MedDRA编码和医学术语
- 具备良好英语读写能力，能理解英文安全信息和法规文件
- 细致严谨，有优秀的组织和多任务处理能力
申请策略
- 申请时表达对患者安全的热情和对细节的重视，面试中准备实际案例展示处理ICSR的流程
- 了解Syneos Health的公司文化和近期项目，展现对公司的兴趣
- 突出药物警戒或临床研究相关实习/工作经历，特别是ICSR处理经验
- 强调MedDRA编码能力、安全数据库操作和法规知识
- 展示英语水平，如通过CET-6或雅思/托福成绩，以及英文项目经验
- 提前学习MedDRA编码基础，可通过在线课程或培训
- 熟悉GCP、GVP等行业指南，了解最新法规动态
面试指南
- 使用STAR法则：描述情境、任务、行动和结果，突出你的具体步骤和成果
- 强调合规性和细节：提及遵循SOP、交叉检查、与团队沟通等
- 展示学习能力：说明你如何快速掌握新系统或新法规
- 请描述你处理个例安全报告（ICSR）的流程
- 你如何确保数据录入的准确性和完整性？
- 谈谈你对MedDRA编码的理解和实际应用经验
- 你如何应对多个紧急任务和严格截止日期？
- 你对GCP和GVP有何了解？它们在药物警戒中的作用是什么？
职位点评
61
综合评分
稳定CRO、社会意义强、专业技能积累佳，但薪酬一般且WLB不明确。
更适合这类人
适合追求职业意义感和稳定发展的求职者，尤其是对患者安全有使命感的人；若注重工作生活平衡或高薪资则需谨慎。
表现最好
使命价值
相对薄弱
工作生活
薪资福利55
成长发展70
工作生活40
使命价值80
薪资福利
55较低
薪资未明确披露，但在大连CRO中处于市场中等水平；福利未提及，整体补偿性一般。
薪资信号未披露（AI估算：8K-12K/月）
成长发展
70中等
技能成长在药物警戒领域明确，公司提供职业发展培训，但技术栈偏传统，非前沿。
技术前沿传统/成熟技术
技术栈MedDRA、Safety Database、GCP、GVP、ICH
成长机会career development and progression、technical and therapeutic area training、supportive and engaged line management
业务类型cost_center
工作生活
40较低
现场办公，地点大连开发区？未明确，但通常CRO办公室在市区或园区，WLB未明确。
工作模式仅现场办公
办公地点未明确
加班情况未提及（无法判断）
使命价值
80较高
药物警戒直接关系患者安全，社会意义较强；行业稳定增长，公司创新跟随主流。
行业发展稳定成熟行业
社会影响正向社会影响力较高
使命信号accelerate customer success、shape the future of healthcare、impact someone's life
创新程度稳健跟随主流
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