初级PV官员
Junior PV Officer
医学在这里不断前进。你也将如此。
在PrimeVigilance，患者安全不是工作的某一部分。而是我们存在的理由。
我们是一家全球性的药物警戒专业公司。我们的团队帮助客户应对复杂的法规，同时将患者安全置于每个决策的核心，从早期开发到上市后监测。越来越多地，我们创造的价值不仅在于处理安全数据，还在于解读数据：尽早发现重要的信号，并将其转化为客户可以采取行动的见解。
这项工作需要充满好奇心的头脑、解决问题的人和注重细节的专家。它也需要一个值得留下的文化。在欧洲、北美、南美、亚洲和澳大利亚，我们工作在一个以善良、灵活性、成长和归属感为基础的环境中，同事之间互相支持，好的想法无论来自何处都会被听到。
如果你想要一份有真正意义、具有全球影响力，并且在保护患者的同时有机会持续成长的工作，你会在这里感到自在。我们期待收到你的来信。
· 为项目团队代表客户和公司开展的其他活动提供支持
· 在约定的范围和时间框架内执行ICSR管理单元的活动（包括但不限于）：
· 按照适用法规、PrimeVigilance程序以及客户特定要求和时间表，从所有来源处理个例安全报告（ICSR）
· 执行ICSR后续跟进
· 严重不良事件/可疑且非预期的严重不良反应（SAE/SUSAR）管理（揭盲、临床试验核对、方案审查、安全计划审查）
· 核对（临床、合作伙伴）
· 个人数据保护
· 产品质量问题投诉处理及与质量保证部门的互动
· 医疗信息互动
· MedDRA和WHO编码
· 数据库输出和报告（包括向客户每月报告的数据）
· 工作流程与资源管理
· 对部门内新员工和更初级员工进行指导和培训
· 支持与ICSR管理相关的PV流程，既在PrimeVigilance内部，也对客户
· 更高级别的同事可根据SOP对更初级职位的任务进行执行
· 在约定的范围和时间框架内执行ICSR管理单元的活动
· 按需支持RA & PV网络部门，包括担任LCPPV（药物警戒当地联系人）
查看英文原文
Medicine moves forward here. So will you.
At PrimeVigilance, patient safety is not one part of the job. It is why we exist.
We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.
That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.
If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.
The Junior PV Officer role is a mid senior role that requires previous experience in Pharmacovigilance case processing. It includes:
· Providing support to other activities undertaken by the project team on behalf of the client and the company
- Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
- Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
- Performing ICSR follow up
- SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
- Reconciliation (clinical, partners)
- Personal data protection
- Product Quality Complaint handling and interaction with Quality Assurance
- Medical Information interaction
- MedDRA and WHO coding
- Database Outputs and Reports (including data for monthly reporting to clients)
- Workflow & resource management
- Mentoring and training of new and more junior employees within the department
- Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
- More senior colleague may perform tasks assigned as per SOP to more junior position
- Performing activities in the scope of ICSR management unit within agreed extent and timeframe
- Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager
Requirements:
· Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing
· Excellent communication (written and verbal) skills
· Organization skills, including attention to details and multitasking
· Delegation skills
· Planning and time management
· Technical skills
· Team working
· Advanced literacy (MS Office)
· English – fluent (spoken, written)
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
· Quality: we hold ourselves to the standard patients deserve.
· Integrity and trust: we do the right thing, especially when it is hard.
· Drive and passion: we care about the outcome, because someone is waiting on it.
· Agility and responsiveness: we move quickly, because patients cannot wait.
· Belonging: everyone is welcome, and every voice counts.
· Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.