Sr. PV Specialist/PV Specialist当面告知
昆翎企业管理(上海)有限公司
2026-12-25 00:00:00
大专本科社招
岗位详情
地区:
大连市
·
武汉市
专业要求:
生物科学临床医学药学
岗位职责:
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.
招聘要求:
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.
公司介绍
昆
昆翎企业管理(上海)有限公司
昆翎企业管理(上海)有限公司,成立于2019-12-12,位于上海,法定代表人:崔懿宁,登记状态:存续,注册资本4700万美元,公司类型:港澳台资