The CHC PV Country Safety Head (CSH)
关于工作加入 Excelya,我们在 Audacity, Care and Energy 定义了我们的身份和我们的工作方式。我们相信创造大胆的解决方案并促进一个包容性的环境，合作与个人成长都会随手而行。这个角色是一个令人兴奋的机会来为一支动态和雄心勃勃的团队做出贡献。你将发挥推动创新和对临床研究领域产生影响的关键作用，同时享受刺激性专业环境，鼓励个人和智力增长。主要责任 ·领导和维护当地药物监督功能，确保完全遵守适用的法规要求和公司标准。· 作为卫生当局的主要光伏接触者，并负责光伏检查，审计和监管互动。· 监督当地安全监测活动，包括案例管理，信号检测，风险管理和报告义务。·确保地方光伏质量系统的有效性，包括合规监控，调查，CAPA,培训和检验准备。· 与跨职能团队和外部供应商合作实施强大的光伏流程，确保适当的安全治理。·通过主动识别风险，监管情报和利益相关者的参与推动本地光伏运营持续改善。- 生物科学，药业，医学或相关领域学位。- 以 SK 为基础，具有斯洛伐克语流利能力 （理想地母语）和英语流利性 （口头和书面）. - 至少5年的药物监督经验，在类似职位的前经验将被视为资产 - 强有力的当地和全球光伏法规知识。- 对审计，检查和供应商管理的经验。- 优秀的组织和领导技能。- 强大的沟通和合作技巧跨功能团队之间。这就是使我们独特的原因。我们是一个代表900个优秀公司的年轻，雄心勃勃的医疗企业，旨在成为欧洲领先的中型 CRO 拥有最好的员工经验。我们的一站式提供商服务模式 - 提供完整的服务，功能性服务提供者和咨询 - 使你能够通过各种项目发展。与杰出专家一起工作，你将有助于改善你的健康状况
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About the Job
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This role is an exciting opportunity to contribute to a dynamic and ambitious team. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
Main Responsibilities
- Lead and maintain the local Pharmacovigilance function, ensuring full compliance with applicable regulatory requirements and company standards.
- Serve as the primary PV contact for Health Authorities and lead PV inspections, audits, and regulatory interactions.
- Oversee local safety monitoring activities, including case management, signal detection, risk management, and reporting obligations.
- Ensure the effectiveness of local PV quality systems, including compliance monitoring, investigations, CAPAs, training, and inspection readiness.
- Partner with cross-functional teams and external vendors to implement robust PV processes and ensure appropriate safety governance.
- Drive continuous improvement of local PV operations through proactive risk identification, regulatory intelligence, and stakeholder engagement.
Requirements
-Degree in Life Sciences, Pharmacy, Medicine, or related field.
- Based in SK with Fluency in Slovak language (ideally native speaker) and fluency in English (spoken and written) is required.
- At least 5 years of experience in pharmacovigilance, prior experience in a similar position will ne considered an asset
- Strong knowledge of local and global PV regulations.
- Experience with audits, inspections, and vendor management.
- Excellent organizational and leadership skills.
- Strong communication and collaboration skills across cross-functional teams.
Benefits
Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here’s what makes us unique.
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model - offering full-service, functional service provider, and consulting - enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.
Originally posted on Himalayas