高级专员，法规与PV网络
Senior Specialist, Regulatory & PV Network
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在复杂法规中导航，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、解决问题的人和注重正确性的人。它还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。
高级专家，监管与药物警戒网络负责根据监管要求制定策略，并基于已建立的药物警戒和监管计划推动监管和药物警戒交付物。他们还作为监管和其他职能领域（包括外部合作伙伴、客户、监管机构和/或顾问）之间的联络人，在规划、组织和准备监管交付物时进行协调，遵循项目、公司和行业监管策略。
高级专家还将担任指定国家的药物警戒当地联系人。
职位职责
· 担任指定国家的药物警戒当地联系人
· 在中等/高复杂度项目中担任领导和职能代表，确保有效且快速地协调和管理监管交付物，推动团队达成既定目标，并遵守既定程序、跟踪器和模板
· 在团队高级成员的帮助下，制定策略并管理设置活动（项目管理计划、联合操作规程、POAs和核心文件）
· 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，通过实施预防措施加以应对
· 解决问题并支持实现绩效问题或延误的满意解决
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 Specialist, Regulatory and PV Network 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 also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies.
The Senior Specialist will also act as Local Contact Person for Pharmacovigilance for the designated country.
Job Responsibilities
· Act as Local Contact Person for Pharmacovigilance for the designated country
· Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates
· With the help of a senior member of the team, develop strategy and manage set up activities (Project Management Plan, joint operating procedures, POAs and core documents)
· Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures
· Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures
· Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports
· Ensure correct training assignment to and training compliance by the LCPs
· 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
· Provide support to proposal development and input to budgets, provide department representation to BD meetings as required
· Prepare client’s invoices and review/approve vendors’ project invoices
· Provide training, coaching and mentoring to junior members of staff
· Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
· Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
· Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required
· Track LCPs' key performance indicators and prepare monthly summary reports
· Provide feedback on performance of vendors to aid their assessment
· Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.
- Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
- Strong experience within pharmaceutical or CRO industry or Regulatory body
- Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency
- PV training and/or working experience and other educational or professional background as required locally
- Fluent in English, both written and verbal
- Candidate must be proficient in the official language of the country in which they are based, as this is essential for local interactions and compliance
- Good planning and organizational skills
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Good attention to detail
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.