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Medical Writer III (Pharmacovigilance)

其他未标注地域
公司Ergomed
薪资未公开
工作地点Zagreb, , Croatia
地域资格未标注地域
时区要求无特别要求
用工类型Full-time
发布时间昨天
数据来源SmartRecruiters
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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,我们在一个以善良,灵活性,成长和归属为基础的环境中工作。同事们互相支持,无论他们来自哪里都能听到好想法。如果你想要有真正目的的角色,全球范围以及继续增长的机会,同时帮助保护病人,你将感到自在在这里。我们很想从你那里听说。我们正在寻找一位经验丰富的药物警医学作家加入我们的不断发展的医疗写作团队。我们正在追求的是:医疗作家将负责医学写作,包括:· 作者,审查和质量检查一系列监管和药物警文件,包括:·PSURs/PBRERs · PADERs · ACOs · DSURs ·风险管理计划 (RMP) ·确保文档是科学准确的,符合法规,并在达成的时间内交付。· 与跨职业团队合作,有效地分析,解释和呈现安全数据。·作为客户的可信赖联系点,支持项目交付并促进强的工作关系。·为年轻医学作家提供指导,辅导和知识共享以支持他们的专业成长和发展。· 贡献过程改进和持续提高医疗写作质量标准。·博士学位,药学或生命科学 (士或博士学位是理想的)· 最少2年的经验在医学写作和书籍方面。

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.

We are looking for an experienced pharmacovigilance medical writer to join our growing medical writing team.
What We're Looking For: A highly motivated and detail-oriented medical writer who combines strong regulatory writing expertise with a client-focused mindset and a passion for developing others. You will play a key role in delivering high-quality regulatory documents, strengthening client relationships, and supporting the growth of the wider team. The Medical Writer will be responsible for medical writing including:
Key Responsibilities:
· Author, review, and quality check a range of regulatory and pharmacovigilance documents, including:· PSURs/PBRERs
· PADERs
· ACOs
· DSURs
· Risk Management Plans (RMPs)

  • Ensure documents are scientifically accurate, regulatory compliant, and delivered within agreed timelines.
  • Collaborate with cross-functional teams to analyse, interpret, and present safety data effectively.
  • Act as a trusted point of contact for clients, supporting project delivery and fostering strong working relationships.
  • Provide guidance, mentoring, and knowledge sharing to junior medical writers to support their professional growth and development.
  • Contribute to process improvements and the continuous enhancement of medical writing quality standards.
  • MD, pharmacy or Life Science degree (Masters or PhD is desirable)
  • Minimum 2 years' experience in Medical Writing and associated fields (case processing, signal detection or risk management) ideally within a CRO environment
  • Ability to manage multiple and varied tasks and prioritize workload with attention to detail
  • Ability to effectively train and mentor Associate Medical Writers
  • Must be a strong team player
  • Fluency in English, an additional language is a benefit

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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