本地注册和PV网络专家
Specialist, Local Regulatory and PV network
医疗在此前进。你也会这样做。在 PrimeVigilance,患者安全不是工作的一部分。这就是我们存在的原因。我们是一个全球药物监督专家。我们的团队帮助客户导航复杂的规则，同时保持病人安全在每个决定的中心，从早期开发到后市场监测。越来越多地，我们创造的价值不仅是处理安全数据，而且是在解释它：早点发现重要信号并将其转化为客户可以采取行动的见解。这项工作需要好奇心，解决问题和专家关心正确的做法。它还需要一个值得留下来的文化。在欧洲，北美，南美洲，亚洲和澳大利亚各地，我们在建立在友善，灵活性，增长和归属的环境中工作，同事相互支持，无论他们来自哪里都能听到好想法。如果你想要具有真正目的，全球影响力和继续发展的机会，同时帮助保护患者，你将感到自在在这里。我们很想从你那里听到.RA&PV 专家将担任负责药物监督和监管事务 (LCPPV/LCPRA) 的当地国家人员，并作为澳大利亚首要的地方 RA&P V 代表来确保遵守国家药物监控和监管要求。本职位负责在本地层面执行光伏和药物监督活动，支持营销许可证持有人 (MAH) 在整个产品生命周期中保持产品的合规性。主要责任 · 根据需要与授权所有者及当地监管机构迅速有效沟通 · 根据地方要求与当地监管当局的主要联系人：监管事务和医疗警 · 为负责地区提供本地监管情报检查和专家咨询 · 收集和报告本地疑似 ADR 或 ICS （FU,翻译）· 支持与全球许可证所有者系统和当地法规的遵守，制定和实施本地药物监督管理体系。· 开展本地非索引文献选以及对监管机构网站/网站进行潜在有害药物反应 (ADR) 和安全信息的选。· 在本地层面保持准确记录和文件。· 为研究人员提供支持。
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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.