助理药物警戒项目总监（交付）- 欧洲
Associate Pharmacovigilance Project Director (Delivery)- Europe
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见解。
这项工作需要充满好奇心的头脑、解决问题的人才以及真正关注正确做事的专家。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，无论来自何处的好想法都会被听到。
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。
- 确保代表PrimeVigilance客户的各项合同活动在预算内完成，按时交付，质量良好，并符合相关法规要求。
- 在代表PrimeVigilance客户进行的各项合同活动中，作为药物警戒专家支持项目团队，必要时提供支持。
- 根据需要，为项目管理部负责人、药物警戒运营部负责人及高级管理层提供支持，在代表客户和公司进行的其他活动中发挥作用。
- 与直接下属一起代表客户和PrimeVigilance的利益，旨在保持既定的项目范围。
- 监督项目范围、项目时间表和项目成本的变更管理，视情况而定。
- 维护良好的客户关系，确保为每位客户提供一致的高质量工作。
- 参与问题升级流程。
- 了解客户的药物警戒要求，并确保提供的服务满足所有要求。
- 监督和监控项目启动和维护活动的计划；根据需要参加客户会议。
- 对客户交付物有全面的了解。
- 参与根据需要交付给客户的任务。
- 对与客户的所有沟通问题进行监督。
- 监督项目团队的培训。
- 与其他PrimeVigilance或客户的相关部门密切合作
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.
- Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered
- within budget, and are on time with good quality and in compliance with the applicable regulatory requirements.
- Support project teams as PV expert on all contracted activities performed on behalf of PrimeVigilance clients, as necessary.
- Providing support to Head of PM department, Head of PV Operations and senior leadership management, as applicable, in other activities undertaken on behalf of the client and thecompany.
- Together with direct reports representing the client's and PrimeVigilance interests with the aimof keeping the agreed project scope
- Oversee management of changes to the project scope, project schedule and project costs, as applicable
- Maintaining good client relations and ensuring a consistently high quality of work for each client
- Being involved in issue escalation process
- Understand client PV requirements and ensure service provided addresses all requirements
- Overseeing and monitoring Project set-up and maintenance activities planning; attending client meetings, as required
- Having an overview of deliverables to the clients
- Being involved in tasks to be delivered to the client, as applicable
- Oversight on all issues communication with clients
- Overseeing training of project teams
- Close cooperation with other PrimeVigilance and/or the client’s respective departments making sure contracted activities are delivered with high quality and within set timelines
- Assurance that all Primevigilance departments and respective personnel are familiar with the client and the project scope
- Review of client specific core documents (e.g. Joint operational guidelines, Safety management plan,…), as applicable
- Making sure invoices are prepared and sent on time
- Review project specific analysis, as needed
- Advising the client as requested or as appropriate in PV matters such as changes in regulations/guidance
- Providing the client with appropriate qualified resources to ensure their project is managed and handled effectively
- Overseeing the management of Quality Management System activities for the client, as required
- Making sure that quality standards applicable to the respective client are met
- Ensuring compliance with worldwide PV regulatory obligations; manage the process for Quality Events (QEs) and implement corrective and preventative action (CAPA).
- Participation in client audits and inspections
Requirements:
· Excellent client-facing and internal communication (written and verbal) skills
· Varied PV experience in a CRO
· Previous experience within PV Project Management
· Organization skills, including attention to detail and multitasking
· Management skills, including time and issue management
· Conflict resolution skills
· Decision making
· Team working
· Ability to motivate/coach people; leadership
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.