药物警戒

公司部门: Clinical Development

工作地点:北京

发布日期:2021-11-05

招聘人数:1人

职位类型:生物制药/医疗器械

职位描述:

主要职能:

1. 进行个例安全报告管理,以高效完成下述活动,达成工作目标:

a) 保障所有临床试验中PV部门收到的个例安全报告(首次或、随访或质疑回复)严重不良事件的分拣、内部质控和归档有序进行。

b) 根据适用的中国监管部门法规和诺诚健华的SOP,负责管理与试验药物相关的安全性信息向国家监管部门的快速递交与试验药物相关的安全性信息。

2. 改善个例报告在PV数据库的管理流程PV系统的个例报告管理,以确保其更有效,并保证PV个例报告管理活动处理流程符合SOP和适用的法规。

3. 承担PV数据库超级用户的责任。

4. 负责与个例报告管理相关的质量及合规控制过程,以确保质量和合规性,包括个例报告延迟递交的根本原因分析,建立和管理纠正措施和预防措施。进行抽样质控,生成质量指标数据,完成质量分析。

5. 监督与个例报告管理处理相关的CRO管理活动,审查CRO质量指标数据。

6. 负责协调翻译个例安全报告的翻译,用于支持美国NDA和BD等。

7. 起草撰写SAE周/报、月报以及SUSAR月报。告

起草SUSAR月报告

SUSAR monthly report draft

8. 生成提供SAE 行列表,用于支持SAE一致性核对查和其他事项。

9. 负责临床PV部门公共邮箱的管理。

10. 参与CRO审计。

11. 完成主管交办的其他工作

Key Objectives/Deliverables:

1. Responsible for ICSR Ccase processing Mmanagement aiming at achieving high efficiency and productivity on following activities:

a) Ensure all activities of case management including triage, internal QC and archiving of all clinical ICSR (initial, follow up or query response) received by PV were carried out in an orderly mannerclinical initial or follow up SAE.

b) Be accountable for the managementManage the expedited submission of to safety information related to investigational drugs National Competent Authority (NCA) of safety information relative to investigational drugs in compliance with applicable Chinese health authority regulations and InnoCare’s SOPs.

2. Participate onin improvingthe improvement of case management process in PV systemdatabase on case management to ensure it is more efficient and keep PV case management activities followingthe process in compliance with SOP and applicable regulations.

3. Takes the role role of PV database super-user.

4. Be accountableResponsible for the Quality Control (QC) and compliance control process relative related to case management tofor ensuring ensure Quality and Compliance, including root cause analysis of late casesubmission root cause analysis, establishing and managing CAPAs. Conduct Sampling QC, generate quality metrics generation and complete quality analysis.

5. Supervises the CRO management activities relevant for related to case processingmanagement, and review CRO quality metrics.

6. Responsible for coordinating ICSR Case translation to support US NDA and BD.

7. Develop SAE weekly/monthly report draftand SUSAR monthly report.

8. Generate SAE LLline listing for to support SAE reconciliation and others.

9. Responsible for management of clinical PV public mailbox.

10. Participate in CRO audit.

11. Other tasks assigned.

任职条件:

岗位要求:

1. 医学、药学、公共卫生、流行病学等相关专业,本科及以上学历;

2. 4年及以上药物警戒工作经验并有PV数据库操作经验者优先;

3. 英文读写精通,熟练操作办公软件;

4. 工作积极高效、有责任心和团队精神、并有较强的学习能力。

Qualifications:

1. Medical, pharmacology, public health or epidemiology background, etc. and bachelor degree or above;

2. At least 4 years of PV experience and PV database operating experience is preferred;

3. Excellent in English reading and writing, proficient in office software;

4. Work actively and efficiently, have a strong sense of responsibility and team spirit, and have a strong learning ability.

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