ICSR主任
Senior Director of ICSR
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。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。
职位概述：负责管理指定人员的ICSR管理单元，确保所有与该单元相关的活动在约定范围内完成。为实现公司的目标和宗旨做出贡献。执行项目预算审查，并为助理总监提供支持和管理。其他职责包括独立分析工作量、生产力和资源利用情况，并进行适当的重新分配，以确保最高质量的绩效，以及与其他部门协调所有与ICSR管理单元相关的活动。需要具备上市后和临床处理及人员管理的丰富经验。
岗位职责：
· 有效管理指定的ICSR管理单元
· 确保ICSR项目团队有足够的资源以实现最大化的生产率和利用率
· 为正在进行的项目设定生产率目标，并根据需要审查建议的目标更新
· 根据报告和分析，确定ICSR管理单元内适当的资源重新分配，或与其他资源部门合作进行跨单元和部门的资源重新分配
· 管理助理总监并监督所有员工，确保他们得到充分的利用和高生产率，并在必要时将员工重新分配给其他ICSR主管/团队
· 通知资源部门
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.
POSITION SUMMARY: Manages ICSR Management Unit for assigned staff and ensures all unit-relevant activities are delivered within agreed extent. Contributes to achieving company´s goals and objectives. Performs project budget reviews, and provides support to, and management of, the Associate Directors, ICSR. Other responsibilities include independent analysis of workload, productivity and utilization of resources and their appropriate redistribution to ensure performance of the highest quality as well as coordination with other departments for all activities related to the ICSR Management Unit. Strong experience in post marketing and clinical processing and staff management required.
Role and Responsibilities:
· Managing the assigned ICSR Management Unit effectively
· Ensuring adequate resources within the ICSR project teams to achieve the maximum level of productivity and utilisation
· Setting productivity targets for ongoing projects and reviewing proposed target updates as required
· Based on reports and analyses, defining the appropriate reallocation of resources in ICSR Management Unit, or working with the resourcing unit for reallocation to and from other units and departments
· Managing Associate Directors and oversight of all employees to ensure they are adequately utilised and productive and reallocating employees to other ICSR Leads/teams as necessary
· Notifying the Resourcing department about the need for additional resources for assigned project teams if resources cannot be managed internally and officially opening the requests upon approval and budget confirmations
· Proposing the necessary changes within the project team processes to ICSR leadership
· Finding solutions and introducing best practices to increase productivity and utilization within the ICSR Management Unit
· Training and mentoring of ICSR Line Managers and senior staff.
· Preparing various analyses and reports
· Reviewing budgets and resource allocations for all new projects and new scope of work for existing projects and supporting Directors of Projects, as applicable
· Supporting the Business/Commercial team during development of contracts and proposals, as applicable
· Supporting the Operations and Project Analytics team, as applicable
· Assisting HR in employee recruitment, performance evaluation, promotion, retention and termination activities
· Reviewing and approving all Critical CAPAs from the ICSR Management Unit
· Reviewing and addressing any requests from Quality department regarding ICSR Management Unit
· Reviewing and updating PrimeVigilance operating procedures and guidelines, as applicable
· Business development activities
Education, qualifications and professional memberships: Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance - Intermediate.
EXPERIENCE: Extensive experience in pharmacovigilance case processing including post marketing, clinical and ideally medical devices. Demonstrated leadership experience at a senior level.
SPECIAL SKILLS (Advanced):
· Excellent communication (written and verbal) skills
· Excellent organization skills, including attention to details and multitasking
· Excellent management skills, including delegation skills, time and issue management
· Technical skills
· Team working
PC SKILLS: Advanced literacy (MS Office) - Advanced:
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.