高级福利/风险专员
Senior Benefit/Risk Associate
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。
我们是一家全球药物警戒专家。我们的团队帮助客户应对复杂的法规,同时将患者安全作为每个决策的核心,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,更在于解读数据:尽早发现重要的信号,并将其转化为客户可以采取行动的洞察。
这项工作需要充满好奇心的头脑、解决问题的人和关心把事情做对的专家。也需要一个值得留下的文化。在欧洲、北美洲、南美洲、亚洲和澳大利亚,我们在一个以善良、灵活、成长和归属感为基础的环境中工作,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,你会在这里感到如鱼得水。我们期待收到你的来信。
高级风险收益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。
主要职责:
· 参与信号检测活动,包括设置
· 审核准备信号检测报告所需的清单
· 撰写复杂的信号检测报告,包括质量控制
· 评估和分类潜在信号
· 一旦发现潜在信号,提出相应的行动方案
· 协助准备与监管机构的沟通材料
· 记录保存和维护相关跟踪工具
· 与其他公司部门合作,确保信号管理符合相关的PrimeVigilance程序和监管要求
- 生命科学或生物医学领域教育背景(药学学位优先)。
- 具有信号检测相关经验者优先。
- 对贡献于患者安全有强烈承诺,并积极主动地学习。
- 优秀的时间和问题管理能力,能够委派任务、多任务处理并保持严格的关注细节。
- 良好的人际和沟通能力。
- 英语水平高级,口语和书面表达均达到至少B2级别
当你加入Ergomed集团,你将带来改变。
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 Senior Benefit-Risk Associate will be working as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.
Key responsibilities:
· Participating in signal detection activities including set-up
· Reviewing line listings required for preparation of signal detection report
· Drafting complex signal detection reports, including quality control
· Evaluating and categorizing potential signals
· Proposing a course of action whenever a potential signal is identified
· Providing support for preparation of communication with regulatory authorities
· Record keeping and maintenance of relevant tracking tools
· Working with other company departments to ensure that signal management is conducted in accordance with relevant PrimeVigilance procedures and regulatory requirements
- Educational background in Life Sciences or Biomedical fields (Pharmacy degree preferred).
- Demonstrated previous experience in signal detection is strongly preferred.
- Strong dedication to contributing to patient safety and a proactive approach to learning.
- Excellent time and issue management skills, with the ability to delegate, multitask, and maintain strict attention to detail.
- Strong interpersonal and communication capabilities.
- Advanced proficiency in English, both verbal and written (minimum B2 level)
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.