药物警戒审计员 - 自由职业岗位（1FTE 或 0.6 FTE 及以上）
Pharmacovigilance Auditor - Freelance Position (1FTE or 0.6 FTE and above)
Medicine moves forward here. So will you.
ADAMAS Consulting帮助全球制药和生物技术公司维持最高质量、合规性和患者安全标准。自2007年以来，我们与GCP、GVP、GMP、GLP和计算机系统合规领域的组织建立了合作关系，并受到生命科学领域众多知名企业的信任。
我们认为我们的工作不仅仅是审计。在最好的情况下，它是一种情报：帮助客户看到最重要的合规风险，并防止可能危及患者的潜在问题。这需要敏锐、独立的思维和深厚的专业知识，而这正是我们的员工所具备的。
在这里，你的知识被重视并共享，而不是被孤立。我们建立了一个支持性、协作性的环境，鼓励专业成长，并让你能够在这个行业中产生真正的影响力，与该领域最受尊敬的公司之一合作。
ADAMAS Consulting正在寻找一名自由职业的PV审计员，负责覆盖欧洲的审计工作。全职和兼职（0.6+ FTE）都将被考虑
· 根据预期的质量和时间表，规划、准备、执行、报告和后续跟进（包括CAPA计划）各种类型的药物警戒（PV）审计
- 基于对所有监管要求和良好药物警戒实践（GVP）的全面理解执行审计
- 代表制药/生物技术行业的客户公司执行GVP质量保证项目
- 具备为多种利益相关方进行和领导内部和外部药物警戒审计的经验
- 精通国家和国际药物警戒法规和指南
- 熟练管理项目并确保按时交付成果
- 能够以务实的方式识别问题并提供解决方案
- 生命科学学士学位优先
- 审计需要出差，此外还需要进行远程审计
当你加入Ergomed集团，你就能通过帮助将安全有效的药品治疗带给全球患者而产生影响。你将加入一个充满热情和协作精神的专家团队，他们在临床研究、药物警戒和质量咨询领域具有专业知识。
我们在许多方面都多元化，但我们的价值观将我们团结在一起。我们的价值观是我们工作的体现，而不是墙上的标语。如果它们听起来像你，你会在这里感到宾至如归。
· 质量：我们对自己有高标准
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Medicine moves forward here. So will you.
ADAMAS Consulting helps the world's pharmaceutical and biotechnology companies uphold the highest standards of quality, compliance and patient safety. Since 2007 we have partnered with organizations across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences.
We think of our work as more than auditing. At its best it is intelligence: helping clients see the compliance risks that matter most and prevent the problems that could put patients at risk. That takes sharp, independent thinking and deep expertise, which is exactly what our people bring.
Here your knowledge is valued and shared, not kept in silos. We have built a supportive, collaborative environment where professional growth is encouraged and where you can make a real impact across the industry, working alongside some of the most respected companies in the field.
ADAMAS Consulting is looking for PV Auditor on a freelance basis to cover audits across Europe. Both full and part time (0.6+ FTE) will be considered
· Planning, preparation, conduct, reporting and follow up (including CAPA plans) of various types of Pharmacovigilance (PV) audits according to expected quality and timelines
- Executing audits based on a comprehensive understanding of all regulatory requirements and Good Pharmacovigilance Practice (GVP)
- Performing GVP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.
- Experience in conducting and leading internal and external Pharmacovigilance audits for a variety of stakeholders
- Expert knowledge of national and international Pharmacovigilance legislation and guidelines
- Proficient in managing projects and ensuring deliverables are provided timeously
- Ability to identify issues and offer solutions in a pragmatic way
- Bachelor’s Degree in Life Sciences preferred
- Travel will be required for audits, additional to conducting remote audits
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.