艾昆纬
Operation Specialist1
Operation Specialist1
发布于 大约 3 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
高中/中专
医疗、制药与临床研究
Microsoft Office
Clinical Research
Sop Compliance
Ae Reporting
Narrative Writing
AI 估算 · 8k–15k
跨国CRO药物警戒岗位，大连薪资水平中等偏上，专业性强，市场需求稳定，月薪预估8-15K。
职位详情
关于这个职位
该职位主要负责药物警戒（Pharmacovigilance）领域的安全数据处理，包括不良事件的接收、评估、录入、编码和撰写医学叙述
你将与跨职能团队协作，确保数据符合法规和公司标准，适合希望在药企CRO领域积累专业经验的求职者
最低要求
High School Diploma or equivalent in scientific or healthcare discipline or allied life sciences (Req)
Bachelor's degree in life sciences or related field and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience (Req)
Good knowledge of medical terminology (Intermediate)
Working knowledge of applicable Safety Database and other internal/client applications (Intermediate)
Knowledge of applicable global, regional, local clinical research regulatory requirements (Intermediate)
Excellent attention to detail and accuracy (Intermediate)
Maintain high quality standards (Intermediate)
Good working knowledge of Microsoft Office and web-based applications (Intermediate)
Strong organizational skills and time management skills (Intermediate)
Strong verbal/written communication skills (Intermediate)
Self-motivated and flexible (Intermediate)
Ability to follow instructions/guidelines, utilize initiative and work independently (Intermediate)
Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands (Intermediate)
Ability to delegate to less experienced team members (Intermediate)
Ability to be flexible and receptive to changing process demands (Intermediate)
Willingness and aptitude to learn new skills across Safety service lines (Intermediate)
Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients (Intermediate)
Ability to work as a Team Player, contribute and work towards achieving Team goals (Intermediate)
Ensure quality of deliverables according to the agreed terms (Intermediate)
Demonstration of IQVIA core values while doing daily tasks (Advanced)
Extensive use of telephone and face-to-face communication requiring accurate perception of speech (Intermediate)
Regular sitting for extended periods of time (Intermediate)
May require occasional travel (Intermediate)
Flexibility to operate in shifts (Intermediate)
工作职责
Prioritize and complete the assigned trainings on time.
Process Safety data according to applicable regulations, guidelines, SOPs and project requirements.
Perform Pharmacovigilance activities including collecting and tracking incoming AE/endpoint information, determining initial/update status, database entry, coding AE and Products, writing narratives, Literature related activities.
Ensure to meet quality, productivity and delivery standards per project requirements.
Ensure compliance to all project related processes and activities.
Read and acknowledge all necessary IQVIA SOPs and customer SOPs. Ensure training is executed timely.
Creating, maintaining and tracking cases as applicable to the project plan.
Identify quality problems and bring to senior team member's attention.
Demonstrate problem solving capabilities.
Liaise with different functional team members (project management, clinical, data management) and healthcare professionals.
May liaise with client on day-to-day case processing activities.
Mentor new team members if assigned.
Attend project team meetings and provide feedback.
Perform other duties as assigned.
Lead/Support department initiatives.
% compliance to all people practices and processes.
May perform medical review of non-serious AEs/ADRs including coding review, medical history, concomitant medications, expectedness/listedness, causality assessment, and communicate corrections.
优先资格
or equivalent combination of education, training and experience (Pref)
AI 洞察
优缺点分析
优点
- 全球领先的CRO平台，提供规范的培训和职业发展机会
- 药物警戒是制药行业核心职能，经验积累具有长期价值
- 工作内容专业且流程化，适合细心且有条理的求职者
- 可能存在倒班或加班需求，尤其在国际项目中
- 适合细心、有条理、对药物安全领域感兴趣，且愿意在规范流程中稳步发展的求职者
缺点 / 挑战
- 工作重复性较高，需长时间面对数据录入和文档处理
- 需严格遵循SOP和法规，容错率低，压力较大
角色解读
- 可晋升为高级操作专员或团队主管，负责更复杂的病例和团队指导
- 可转向药物警戒其他领域如信号检测、风险管理或临床开发
- 积累经验后有机会进入监管事务或医疗事务等更高阶岗位
- 接收和评估来自不同来源的药物不良事件数据，确保符合法规和公司标准
- 在数据库中录入、编码不良事件，并撰写医学叙述，保证数据完整准确
- 与项目团队、临床及数据管理部门协作，处理日常病例并及时上报质量问题
- 熟悉药物警戒相关法规和SOP，掌握不良事件处理流程
- 熟练使用Safety Database及Microsoft Office，具备医学术语知识
- 注重细节，能同时处理多项任务并在截止日期前完成工作
申请策略
- 在面试中表现出对质量合规的重视和对流程的尊重
- 了解IQVIA的核心价值观，并准备相关案例体现团队合作精神
- 突出药物警戒或临床试验相关经验，尤其是不良事件处理和数据录入
- 强调对SOP和法规的熟悉程度，以及细节把控能力
- 展示医学、生命科学或相关学科背景，以及熟练使用数据库等工具
- 学习药物警戒法规（如ICH-GCP、GVP）和常见数据库操作
- 提升医学术语知识，尤其是常见疾病和药物名称
- 练习多任务处理和时间管理能力，适应快节奏环境
面试指南
- 情景-任务-行动-结果（STAR）框架：描述具体场景、分配任务、采取行动和达成结果
- 强调合规和质量的权衡：说明在遵循SOP的前提下灵活解决问题的思路
- 展示学习能力：即使没有完全匹配的经验，也可提及快速学习新流程的例子
- 描述你处理不良事件的经验和具体步骤
- 如何确保数据录入的准确性和一致性？
- 当同时处理多个紧急病例时，你如何安排优先级？
- 解释一下你对GVP或相关法规的理解
- 如何处理与同事或客户在病例处理上的分歧？
职位点评
65
综合评分
稳定跨国药企CRO，药物警戒岗，有意义感但WLB一般。
更适合这类人
适合重视工作意义感、希望在全球平台稳定发展，且对WLB要求不高的求职者。
表现最好
使命价值
相对薄弱
工作生活
薪资福利70
成长发展65
工作生活45
使命价值80
薪资福利
70中等
薪资处于行业中等水平，但IQVIA作为跨国巨头福利完善，整体补偿性较好。
薪资信号市场水准 (8K-15K/月)
成长发展
65中等
有明确的培训计划和晋升路径，但成长速度依赖个人表现，技术深度有限。
技术前沿传统/成熟技术
技术栈Pharmacovigilance、Safety Database、GVP
成长机会training、mentor new team members、lead department initiatives
业务类型ambiguous
工作生活
45较低
大连办公室现场办公，但可能存在倒班或加班，WLB一般。
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
工作在药物安全领域，直接贡献于患者健康，意义感较强。
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help improve patient outcomes and population health worldwide
创新程度稳健跟随主流
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