更新于 6月1日
职位描述
药品警戒
Primary Responsibilities:
1. Responsible for ensuring global regulatory reporting compliance by execution of processes and compliance with procedures for processing safety reports originating from clinical studies, literature, hotline, regulatory feedback data, social media and/or other sources for post-marketing products.
2. Identifying and capturing accurately the relevant information of ICSRs (Including serious and non-serious cases from unsolicited and solicited origin; and literature cases, as required) in safety database in accordance with ClinChoice and/or client conventions/guidelines and SOPs and liaising with the client if applicable.
3. Performing quality review for the data entry in the safety database.
4. Ensuring the timely completion and distribution of AE/SAE/SUSAR/ADR/SADR reports to Health Authorities, client and/or client’s business partners etc..
5. Ensuring timely identification of Individual Case Safety Reports and/or relevant safety information during the monitoring of the literature.
6. Maintaining a basic working knowledge of the adverse event safety profile of assigned drugs and labeling documents or IB.
7. Requesting additional information from the appropriate sender (investigators, medical representatives etc.), as required.
8. Interacting with internal or external contacts to resolve issues related to the cases.
9. Responsible for documents archiving in the filing system.
10. Supporting PV project managers to perform project management related work, including but not limited to: SAE reconciliation, revenue recognition, ERP system maintenance, client communication, project document preparation, etc..
11. Mentoring or training junior staff or new joiners as needed.
12. Responsible for safety database creation and maintenance if applicable.
13. Other ad-hoc tasks assigned by PV leadership team.
Qualifications
1. Degree in life sciences or a prior experience in PV would be desirable (1-3 years of PV in experience.).
2. The minimum qualification required would be a college/bachelor’s degree.
3. Basic conversational skills in English required.
4. Computer proficiency, an ability to work with web-based applications, and familiarity with the Windows Professional Operating System and the MS office suite (MS Word/Excel/PowerPoint).
5. Demonstrate understanding of SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, Clinical trial guidelines).
6. Experience in processing safety data within Argus preferred.
1. Responsible for ensuring global regulatory reporting compliance by execution of processes and compliance with procedures for processing safety reports originating from clinical studies, literature, hotline, regulatory feedback data, social media and/or other sources for post-marketing products.
2. Identifying and capturing accurately the relevant information of ICSRs (Including serious and non-serious cases from unsolicited and solicited origin; and literature cases, as required) in safety database in accordance with ClinChoice and/or client conventions/guidelines and SOPs and liaising with the client if applicable.
3. Performing quality review for the data entry in the safety database.
4. Ensuring the timely completion and distribution of AE/SAE/SUSAR/ADR/SADR reports to Health Authorities, client and/or client’s business partners etc..
5. Ensuring timely identification of Individual Case Safety Reports and/or relevant safety information during the monitoring of the literature.
6. Maintaining a basic working knowledge of the adverse event safety profile of assigned drugs and labeling documents or IB.
7. Requesting additional information from the appropriate sender (investigators, medical representatives etc.), as required.
8. Interacting with internal or external contacts to resolve issues related to the cases.
9. Responsible for documents archiving in the filing system.
10. Supporting PV project managers to perform project management related work, including but not limited to: SAE reconciliation, revenue recognition, ERP system maintenance, client communication, project document preparation, etc..
11. Mentoring or training junior staff or new joiners as needed.
12. Responsible for safety database creation and maintenance if applicable.
13. Other ad-hoc tasks assigned by PV leadership team.
Qualifications
1. Degree in life sciences or a prior experience in PV would be desirable (1-3 years of PV in experience.).
2. The minimum qualification required would be a college/bachelor’s degree.
3. Basic conversational skills in English required.
4. Computer proficiency, an ability to work with web-based applications, and familiarity with the Windows Professional Operating System and the MS office suite (MS Word/Excel/PowerPoint).
5. Demonstrate understanding of SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, Clinical trial guidelines).
6. Experience in processing safety data within Argus preferred.
工作地点
大连甘井子区网络产业大厦
公司信息
昆翎(北京)医药科技发展有限公司
D轮及以上 · 1000-9999人 · 医药研发/生产外包（CXO）
已审核
公司介绍
昆翎（ClinChoice）是一家致力于为生物医药和医疗器械客户提供高品质一站式服务的临床阶段CRO，服务包括临床运营、项目管理、生物统计、数据管理、注册事务、医学事务和药物警戒。昆翎已经在中国、美国、欧洲、印度、日本和菲律宾建立了主要的临床交付中心，目前在全球拥有1800多名员工，其临床运营团队覆盖了亚、欧、北美等七个国家和地区。高盛直投部董事总经理、昆翎董事会成员许小鸥先生认为，“随着创新疗法在全球的增长，CRO公司提供高效、可靠的研发服务能力变得尤其重要。昆翎独特的价值主张结合了其对于本地市场的了解、国际药物研发的经验以及高效的团队执行能力。我们坚信公司强劲的管理层团队以及其高效的执行能力，将为昆翎的发展开启新的篇章。
工商信息
企业名称 昆翎（北京）医药科技发展有限公司
企业类型 有限责任公司（自然人投资或控股的法人独资）
法人代表 刘东
经营状态 存续
成立时间 2008-07-23
注册资本 100万元
认证资质
营业执照信息
