药品警戒和法规事务本地联系人
Local Contact Person for Pharmacovigilance and Regulatory Affairs
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，同时将患者安全置于每个决策的中心，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：及早发现重要的信号，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专家。它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，我们在一个以善意、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。
RA & PV专家将担任澳大利亚的药物警戒和监管事务国家负责人（LCPPV/LCPRA），并作为主要本地RA&PV代表，确保符合澳大利亚的药物警戒和监管要求。该职位负责在本地层面执行药物警戒和监管事务活动，支持上市许可持有人（MAH）在整个产品生命周期中保持合规性。
主要职责
· 按需与MAH和当地监管机构进行及时有效的沟通
· 根据当地要求，作为监管事务和药物警戒的当地监管机构的主要联系人
· 为负责地区提供本地监管情报筛选和专业建议
· 收集和报告当地疑似不良反应（ADR）或ICSR（FUs、翻译）
· 对与紧急安全限制和新兴安全问题相关的风险降低措施进行本地管理/监督
· 支持本地药物警戒系统的开发和实施，符合全球MAH系统和当地法规
· 执行本地非索引文献筛选以及监管机构网站/的潜在不良药物反应（ADR）和安全信息筛选
· 在本地层面保持准确的记录和文件
· 为R
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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 RA & PV specialist will act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) and serves as the primary local RA&PV representative to ensure compliance with national pharmacovigilance and regulatory requirements in Australia. This position is responsible for executing PV and RA activities at the local level, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle.
Main responsibilities
· Prompt and effective communication with MAH and local regulatory authorities as required
· Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirements
· Provision of local regulatory intelligence screening and expert advice for the responsible region(s)
· Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations)
· Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues
· Support with development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulations
· Perform local non-indexed literature screening and screening of regulatory authority website/s for potential Adverse Drug Reactions (ADRs) and safety information
· Maintain accurate records and documentation at local level
· Provide support to the RA & PV Global operations team
· Preparation and collection of documentation for submissions to the regulatory authorities
· Review and linguistic input on local Product Information and Mock-ups
· Ensure compliance with MAH's and PrimeVigilance's procedures
· Support audits and Inspections
· Handle local QA tasks such as suspected falsified products, quality alerts received from health authorities and other quality-related requirements received from the local market
- Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
- At least 3 years of pharmacovigilance or safety-related experience in pharmaceutical, CRO, or regulatory environment
- Good understanding of ICH GVP and local pharmacovigilance requirements (training or practical exposure)
- Experience in case handling, literature screening, or local PV activities is preferred
- Prior experience in Regulatory Affairs is preferred but not mandatory
- Proficiency in English and additional language knowledge is advantageous
- Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint
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.