药物警戒协调员（需日语能力）
Pharmacovigilance Coordinator (Japanese Skills Required)
PSI 是一家领先的合同研究组织，拥有超过 30 年的行业经验，为客户提供稳定与创新相结合的完美平衡，同时也为员工提供这样的环境。我们专注于在多种治疗适应症领域提供高质量且按时的服务。
我们正在寻找一位知识渊博、积极主动的药物警戒协调员加入我们充满热情和活力的团队。
在此职位中，您将为公司的全球药物警戒部门及国家临床照护者（ICCC）在临床试验中的相应服务提供日常支持。您将在临床试验期间处理并报告安全信息（包括电子报告）。您将协助提高患者护理质量和安全性，涉及新型药品和研究设备的使用，并收集相关且可靠医学科学信息。
职责范围包括：
· 作为安全桌面和临床项目团队的联系人，确保安全报告（如严重不良事件 SAE 和其他可报告不良事件 RAE）的适当接收、及时分发、记录和归档
· 将安全报告录入安全数据库
· 对收到的安全报告进行非医学审查/分类
· 对安全数据库中录入的数据进行质量控制
· 将安全查询分发给各研究中心/研究者
· 维护并及时更新公司特定项目的 SAE 分发名单
· 审核并及时更新 PSI 项目团队维护的特定项目 SAE 跟踪表
· 在专门的日本科学数据库中进行文献检索并进行文章筛选
· 维护药物警戒文档及相关记录，确保所有相关信息保持最新并正确记录
- 大学或本科毕业（生物学、生物科学或药学专业优先）
- 英语和日语具备全职工作水平的熟练能力
- 至少一年临床研究相关工作经验，如临床试验协调员或其他类似临床运营岗位，药物警戒协调员、法规专家、数据管理专家等将为加分项
- 行政工作经验
- 具备安全数据库使用经验以及向日本监管机构（PMDA）及其他监管机构提交 E2B 报告的经验将为加分项
- 具备组织和规划能力
- 注重细节，能够多任务处理并在快节奏环境中工作
- 协作能力强
查看英文原文
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
We are looking for a knowledgeable and proactive Pharmacovigilance Coordinator to join our enthusiastic and vibrant team.
In this role, you will provide day-to-day support to the company’s global Pharmacovigilance Department and In-country Clinical Caretaker (ICCC) in clinical trials with the corresponding services. You will process and report safety information (including electronic reporting) throughout the course of the clinical trials. You will help to enhance patient care and safety in relation to the use of novel pharmaceuticals and investigational devices, collect relevant and reliable medical scientific information.
The scope of responsibilities will include:
· Serve as a contact point for Safety Desk and clinical project teams ensuring appropriate receipt, timely distribution, documentation, and filing of safety reports such as Serious Adverse Events (SAEs) and other Reportable Adverse Events (RAEs) reports.
· Data entry of safety reports into the safety database
· Non-medical review/triage of incoming safety reports
· Quality control of data entered in the safety database
· Safety queries distribution to sites/ investigators
· Maintenance and timely update of the company’s project-specific SAEs distribution lists
· Review and timely update of project-specific SAEs trackers maintained by PSI project teams
· A literature search conduction in a dedicated Japanese scientific database and article triage.
· Maintain pharmacovigilance documentation and associated records, ensuring all relevant information remains up to date and appropriately documented.
- College or University Degree (Biology, Bioscience, or Pharmacy is preferred)
- Full working proficiency in English and Japanese
- At least 1-year prior experience in Clinical Research as a Clinical Trial Coordinator or similar clinical operational role, Pharmacovigilance Coordinator, Regulatory specialist, Data Management Specialist or the like will be a plus
- Administrative work experience
- Experience with safety databases and E2B reporting to regulatory authority in Japan (PMDA) and other regulators is a plus
- Organizational and planning skills
- Detail-oriented, able to multi-task and work in a fast-paced environment
- Communication and collaboration skills
- Proficiency in standard MS Office applications (Word, Excel and PowerPoint)
We offer:
· Excellent and flexible working conditions
· Extensive training and friendly, collegial team
· Competitive salary and benefits package
· Opportunities for personal and professional growth
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.