赛纽仕
Safety & PV Specialist I
Safety & PV Specialist I
发布于 大约 17 小时前普通员工/个人贡献者
大连市
初级经验
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 · 6k–10k
初级药物警戒专员，外资CRO大连岗位，1年经验，薪资处于行业中等水平，考虑福利和年终奖。
职位详情
关于这个职位
该职位是赛纽仕（Syneos Health）的药物警戒专员，主要负责个体安全报告（ICSR）的收集、处理和报告，以及文献筛选、药物编码、MedDRA编码等
需要具备生命科学或相关学科学士学位及1年以上药物警戒经验，适合希望在CRO领域从事药物安全工作的初级专业人士
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
- 外资CRO，平台大，流程规范，系统培训体系完善，有助于快速积累药物警戒经验
- 行业稳定，药物警戒是药企和CRO的核心职能，需求持续增长
- 工作环境国际化，提升英语和跨文化沟通能力
- 初级岗位薪资涨幅有限，竞争激烈
- 适合生命科学、药学或护理背景，希望进入药物警戒领域，注重稳定性和规范化流程的初级求职者
缺点 / 挑战
- 工作内容重复性较高，需要细心和耐心，易产生职业倦怠
- 监管严格，时间压力大，尤其在快速报告截止期间
角色解读
- 从Safety Specialist I晋升至II、III，逐步承担更复杂的案例和项目管理职责
- 可转向药物警戒团队管理或跨部门岗位，如医学事务、临床运营
- 考取药物警戒相关认证（如PharmD、RAC）增强职业竞争力
- 处理个体安全报告（ICSR），包括数据录入、编码、撰写叙述摘要和监管报告
- 进行文献筛选和药物编码，维护药物词典和MedDRA编码
- 参与SPOR/IDMP相关活动，管理重复ICSR，并执行质量审核
- 熟悉药物警戒流程和ICH GCP/GVP法规
- 熟练使用安全数据库系统及Microsoft Office
- 具备良好的英语读写能力，能处理英文安全信息
- 注重细节，有较强的组织能力和多任务处理能力
申请策略
- 关注Syneos Health的企业文化（强调包容和成长），在面试中表达对患者影响的认同
- 了解CRO行业趋势，尤其是药物警戒外包的常见模式
- 突出药物警戒相关实习或项目经验，包括ICSR处理、数据库使用等
- 强调对GCP、GVP法规的理解，以及MedDRA编码经验
- 展示英语能力，如CET-6或工作使用英语的经历
- 体现细节导向和数据处理能力，如参与过数据清洗或质量审核
- 提前学习MedDRA编码和药物安全数据库（如ARGUS、Lorenz）
- 补充临床研究基础知识，了解临床试验阶段和法规要求
面试指南
- 按照实际经验分步骤回答，例如：接收、评估、录入、编码、撰写、提交
- 强调遵循SOP
- 展示对细节的关注，举例说明如何双检数据或使用清单
- 提到MedDRA版本管理、低级语和高级语映射，以及查询逻辑
- 请描述你处理ICSR的典型流程
- 如何确保安全报告的数据准确性和监管合规性？
- 你对MedDRA编码有何了解？如何处理编码中的歧义？
- 请举例你如何在多任务环境下管理时间和优先级
职位点评
65
综合评分
稳定外资CRO药物警戒初级岗，发展路径明确，薪资中等，WLB未明确。
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
适合重视职业稳定性和社会贡献，对薪资增长要求不高，能接受重复性工作的求职者。
表现最好
使命价值
相对薄弱
薪资福利
薪资福利60
成长发展70
工作生活60
使命价值75
薪资福利
60中等
薪资未明确但属行业中等水平，外资福利通常较好，但初级岗位升薪空间有限。
薪资信号未披露（AI估算：6K-10K/月）
成长发展
70中等
公司提供培训和发展机会，但技术栈属成熟领域，成长路径明确但较慢。
技术前沿主流现代技术
技术栈Pharmacovigilance、ICSR、MedDRA、Safety Database
成长机会career development and progression、technical and therapeutic area training
业务类型profit_center
工作生活
60中等
现场办公，未提及弹性工作或加班情况，地点在大连，生活成本较低。
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
75中等
药物警戒有助于确保药品安全，改善患者生活，行业稳定且受监管鼓励，有一定使命感。
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 solutions that have the ability to dramatically impact someone’s life
创新程度稳健跟随主流
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