赛纽仕
Safety & PV Specialist I - Dalian
Safety & PV Specialist I - Dalian
发布于 大约 15 小时前普通员工/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
Icsr
Meddra
Microsoft Office
AI 估算 · 8k–12k
跨国CRO在大连的PV初级专员，市场薪资约8-12K，考虑外企福利和稳定性，提供13薪。
职位详情
关于这个职位
该职位主要负责药物警戒（PV）相关工作，包括收集、处理和报告个例安全性报告（ICSR）、文献筛选与审阅、药物编码、MedDRA编码及数据管理等
你将确保法规合规，支持临床试验和上市后安全项目
适合有1年以上PV经验、细心且具备良好沟通能力的人
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
- 进入全球知名CRO，接触国际多中心临床试验，积累药物警戒经验
- 公司提供职业发展培训和晋升通道，福利较完善（如补充医疗、年终奖）
- 大连作为服务外包基地，生活成本相对较低，工作性价比不错
- 适合有1-2年PV经验，希望在外企CRO中稳定发展、重视合规细节的候选人
缺点 / 挑战
- 工作内容重复性较高，需处理大量报告，对细节和耐心要求高
- 需适应跨国团队沟通，英语能力要求较高，有时差可能
- 药物警戒责任重大，需严格遵守法规，压力不小
角色解读
- 可晋升为高级PV专员或团队领导，负责更复杂的案例或项目
- 向PV运营经理或合规方向转型，管理Safety团队或流程优化
- 积累经验后进入更大药企或CRO，从事全球药物警戒工作
- 负责个例安全性报告（ICSR）的接收、处理、评估和上报，确保数据完整准确且符合法规
- 进行文献筛选和审阅，完成药物编码、MedDRA编码及数据管理
- 维护安全数据库，支持临床试验和上市后安全项目，参与审计和文件提交
- 熟悉药物警戒流程、GCP/GVP法规及ICH指南
- 掌握安全数据库操作和医学术语
- 英语工作能力良好，能阅读和撰写安全性相关文档
- 细心、有条理，能同时处理多项任务并满足截止日期
申请策略
- 关注公司文化和价值观，Syneos Health强调包容和发展，可在面试中表达对齐
- 了解该公司服务的治疗领域，准备相关领域知识
- 突出药物警戒项目经验，特别是ICSR处理、MedDRA编码和数据库操作
- 强调英语能力，可附上英语成绩或证明
- 列出在临床试验或上市后安全项目中遵守GCP/GVP的实例
- 体现组织能力和细节处理能力，如多项目同时管理的经验
- 复习ICH E2系列指南、GVP模块
- 熟悉常用安全数据库（如Argus、ArisG）的操作，可通过在线课程学习
面试指南
- 使用STAR法则：描述情境、任务、行动和结果
- 对于流程性问题，清晰分步说明
- 对于合规性问题，强调对指南的理解和应用
- 请描述你处理ICSR的完整流程
- 如何确保报告符合GVP和ICH GCP要求？
- 请举例说明你如何处理数据不一致或查询（query）
- 你如何同时管理多个任务并按时完成？
- 你对MedDRA编码的熟悉程度如何？
职位点评
72
综合评分
稳定外企CRO，PV方向，发展路径清晰，薪资中等，WLB一般。
更适合这类人
适合看重职业发展、培训机会和稳定性的求职者，对WLB要求一般的人。
表现最好
成长发展
相对薄弱
工作生活
薪资福利75
成长发展82
工作生活60
使命价值70
薪资福利
75中等
薪资在大连属于中等偏上，外企福利完善（如补充医疗、年终奖），但JD未明确具体薪资幅度，稳定性较好。
薪资信号未披露（AI估算：8K-12K/月）
福利待遇career development and progression、supportive and engaged line management、technical and therapeutic area training、peer recognition and total rewards program
成长发展
82较高
公司重视员工发展，提供培训、导师制和晋升通道，但职位主要是执行层面，成长路径清晰但需时间积累。
技术前沿主流现代技术
技术栈Safety Database、MedDRA、xEVMPD、SPOR/IDMP
成长机会career development and progression、supportive and engaged line management、technical and therapeutic area training
业务类型cost_center
工作生活
60中等
工作地点在大连市区（推测），但JD未提及远程或弹性工作，可能需要现场办公，工作强度一般但有截止期压力。
工作模式仅现场办公
办公地点市区核心地段
加班情况未提及（无法判断）
使命价值
70中等
药物警戒工作对患者安全有直接贡献，但职位偏操作层面，使命感中等。公司强调使命和患者影响，但个人岗位影响力有限。
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shape the future of healthcare、driving impact for customers、defining the pace of patient progress
创新程度稳健跟随主流
Watch Jobs