药物警戒官员（高级职位）
Pharmacovigilance Officer (senior level position)
医学在这里不断前进，你也将随之成长。
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：尽早发现关键信号，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，我们营造了一个以善良、灵活、成长和归属感为基础的环境，同事之间互相支持，好点子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，并且在帮助保护患者的同时能够持续成长的工作，你会在这里感到如家一般舒适。我们期待收到你的来信。
在PrimeVigilance，PV专员是独立的个案处理团队成员，需对多种个案处理服务承担全部责任。
如果你加入PrimeVigilance，你将与不同规模的团队合作，从小型临床试验团队到大型通用上市后监测团队。我们一直在寻找积极主动、有能力且有动力超越任何目标的人。
PV专员应为生命科学或生物医学背景的毕业生，或拥有其他医疗相关学位（如化学、生物学、生物技术、兽医学等），并具备数年个案处理经验。PV专员将作为项目团队的一员，代表PrimeVigilance执行和协助合同药物警戒活动。
职责包括：
· 按照适用法规、PrimeVigilance流程以及客户特定要求和时间表，从所有来源（上市后和临床试验，包括设备和组合产品）处理个体安全性报告。作为关键成员，需有效完成整个工作流程中的所有步骤，除医学审核外。
· 独立处理严重不良事件/可疑非预期严重不良反应（SAE/SUSAR）管理（提交、揭盲、临床试验核对）
· 准备数据库输出结果
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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.
At PrimeVigilance, PV Officers are independent case processing team members who are expected to manage a variety of case processing services with full accountability.
If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them.
The PV Officer should be a Life science / bio medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc.) and have demonstrated experience with several years in case processing. The PV Officer will be working as part of a project team, performing, and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.
Responsibilities include:
· Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. As a key member there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review.
· Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations)
· Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.)
· Mentoring and training of new and more junior employees within the department, including procedure optimization and development
- Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing
- Demonstrated case processing experience
- Time and issue management, delegation, organization and multitasking skills with good attention to detail
- Strong interpersonal and communication skills
- Advanced English skills, both verbal and written, at least C1
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.