高级总监 / 执行总监（医学写作）
Senior Director / Executive Director Medical Writing
医学在这里不断进步，你也将随之前进。
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业公司。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，更在于解读数据：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、解决问题的人和关心把事情做对的专家。它也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、成长和归属感为基础的环境中工作，同事之间互相支持，无论来自何处的好想法都会被听到。
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能够持续成长的职位，你会在这里感到如家一般舒适。我们期待收到你的来信。
高级总监/执行总监 医疗写作是一个高级管理职位，是高级领导团队成员；担任药物警戒医疗写作组负责人，主要职责是确保合同内的药物警戒活动按照公司政策/程序并符合全球法规进行。
职责
· 领导药物警戒医疗写作职能，确保高质量、合规且及时的交付成果。
· 管理和发展药物警戒医疗写作团队，促进绩效、参与度和职业发展。
· 推动质量、合规性、检查准备和持续改进计划，包括SOP、KPI、审计和监管检查的监督。
· 为客户提供、内部利益相关者和项目团队提供战略性的药物警戒医疗写作专业知识和主题领导力。
· 支持业务发展活动，包括提案、投标答辩和客户合作。
· 监督部门资源、预算和运营表现，以确保高效的服务交付。
· 审核监管安全回应，并参与风险管理制度、汇总报告和其他关键药物警戒交付物的制定。
· 建立和维护强大的客户关系，确保卓越的服务和可信赖的合作关系。
· 通过行业参与、出版物和公关活动代表公司对外发声。
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 Director / Executive Director Medical Writing is a senior management position, member of the Senior Leadership Team; Acts as Head of PV Medical Writing Group and has primary responsibility to ensure the contracted PV activities are appropriately performed in line with company policies/procedures and in compliance with global regulations.
Responsibilities
· Lead the PV Medical Writing function, ensuring high-quality, compliant, and timely deliverables.
· Manage and develop the PV Medical Writing team, fostering performance, engagement, and professional growth.
· Drive quality, compliance, inspection readiness, and continuous improvement initiatives, including oversight of SOPs, KPIs, audits, and regulatory inspections.
· Provide strategic PV medical writing expertise and subject matter leadership to clients, internal stakeholders, and project teams.
· Support business development activities, including proposals, bid defenses, and client engagements.
· Oversee departmental resources, budgets, and operational performance to ensure efficient service delivery.
· Review regulatory safety responses and contribute to Risk Management Plans, aggregate reports, and other key pharmacovigilance deliverables.
· Build and maintain strong client relationships, ensuring exceptional service and trusted partnerships.
· Represent the organization externally through industry engagement, publications, presentations, and professional development activities.
The preferred candidate will have:
· Master’s degree in life sciences or healthcare, PhD preferable
· Extensive pharmacovigilance and PV Medical Writing experience, including leadership and people management of high-performing teams.
· Deep knowledge of global pharmacovigilance regulations, with expertise in authoring and reviewing aggregate safety reports and PV procedures.
· Proven experience supporting regulatory compliance, inspections, and pharmacovigilance system oversight, including QPPV or Deputy QPPV responsibilities.
· Strong business acumen with experience supporting proposals, client engagements, and bid defense activities.
· Excellent scientific, regulatory, and analytical capabilities, including translating complex clinical and safety data into clear, high-quality regulatory and scientific documents
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.