监管与PV交付经理
Manager, Regulatory and PV Delivery
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。这是我们存在的理由。
我们是一家全球性的药物警戒专家。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、解决问题的人和关心把事情做对的专家。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，我们在一个以善良、灵活性、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，你会在这里感到自在。我们期待收到你的来信。
监管与PV交付经理负责根据监管要求制定策略，并根据已建立的PV和监管计划推动监管和PV交付。他们积极参与BDM并为新业务的获取做出贡献，同时为高级管理层提供支持。他们还为初级成员提供战略监管指导、培训、辅导和指导；可能需要直接管理员工。
主要职责：
· 对高复杂度的项目和/或交付物承担领导和职能代表角色，确保有效的快速协调和管理以及监管任务的执行，推动团队达成既定目标，并遵守既定程序、跟踪器和模板。
· 为内部和外部客户提供战略建议，并及时识别和解决任何风险/潜在风险，通过实施预防措施。解决问题并确保绩效问题或交付失败得到满意解决。
· 向客户提供建议，处理复杂的查询以及当地法规/指南的变化。
· 确保所有分配到项目中的部门交付任务的团队成员了解任务和时间安排，监控项目预算、实际花费工时与预算的对比，并及时识别和升级任何OoS。
· 协助获取新的
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 Manager, Regulatory and PV Delivery is responsible for developing the strategy based on regulatory requirements and for driving regulatory and PV deliverables based on an established PV and regulatory plan. They actively assist senior management in securing new business by participating to BDMs and
contributing to proposals/budgets. They also provide strategic regulatory guidance, training, coaching and mentoring to junior members; may be required to line manage members of staff.
Main responsibilities:
· Assume leadership and functional representation for projects and/or deliverables of high complexity ensuring effective and rapid coordination and management and execution of regulatory tasks, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
· Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and ensure satisfactory resolution of performance issues or delivery failures.
· Provide expert advice to Clients addressing complex queries and changes in local regulations/guidance.
· Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS.
· Assist in securing new business or repeated business by participating to BDMs, developing and reviewing regulatory sections of proposals, regulatory costing and budgets.
· Prepare client’s invoices and review/approve vendor’s project invoices
· Provide training, coaching and mentoring to junior members of staff
· Support client qualification activities. Ensure audit readiness and assign team members to participate as departmental representatives for audits/inspections and provide responses to any findings/follow up questions.
· Prepare and/or contribute to the Regulatory Newsletter and update regulatory database
when new information is available.
· Ensure collection, QC review and timely dissemination of all regulatory intelligence related to
departmental deliverables. Support interpretation and impact analysis on legislation.
· Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
· Drive department / company initiatives, act as a change champion and successfully manage implementation of the changes (communication, timing and implementation plan)
- Minimum 3 years within pharmaceutical or CRO industry or Regulatory body, of which at least 3 years in a leading/project management role.
- Proven ability to successfully manage global projects.
- Expert knowledge of ICH GCP and/or GVP and most relevant legislation/ local requirements for territories of competency.
Why PrimeVigilance
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.
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