PV Operation

公司部门: Clinical Development

工作地点:北京

发布日期:1000-01-01

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:

能够独立处理一下药物警戒事务:

1.帮助药物警戒负责人建立并改进药物警戒体系以确保其有效性和遵守所有适用的法规和公司政策及标准操作规程;

2.监督管理个例安全性报告处理,快速将试验药物和上市后药品相关安全信息递交给卫生主管部门;

3.与合同研究组织数据管理人员共同制定严重不良反应事件一致性核查计划,并参与严重不良反应事件一致性核查工作;

4.参与相关临床资料的审核,例如:研究方案,知情同意书,病例报告表等,以满足药物警戒合规及安全管理的要求;

5.新药申请(NDA)提交时,递交安全部分,包括安全方面的决策和监管资料;

6.在药物警戒或其他监管机构检查期间,参与向监督管理机构检查人员解释和阐述药物警戒工作内容;

7.为相关部门提供培训;

8.参与管理与各种外部合作伙伴起草和签署药物警戒协议;

9.确保所有内部和外部客户之间的良好沟通和协作,同时确保维持好所有药物警戒标准;

10.在药物警戒工作中,与监管部门保持良好的沟通;

11.完成上级主管交代的其他工作。

Key Objectives/Deliverables:

Qualified individual, with minimum supervision, be able to:

1.Supports the PV head on the establishment and improvement of a PV system to ensure its efficiency and compliance following all applicable regulations and company policies and SOPs;

2.Supervises the management of ICSR case processing and expedited submission to Health Authorities (HA) of safety information relative to investigational and marketed drugs;

3.Collaborate with CRO DM to establish SAE reconciliation plan and participate in the SAE reconciliation;

4.Participates in review of relevant clinical documents such as study protocol, ICF, CRF, etc. to ensure the PV compliance and safety management requirements;

5.Deliver the safety sections in NDA submissions including safety aspects of decision-making, and regulatory documents;

6.Participate in describing and demonstrating the PV activities to regulatory authority inspectors during pharmacovigilance or other regulatory authority inspections;

7.Deliver training to relevant functions;

8.Participate in management of PV agreements drafting and signing with all kinds of external partners;

9.Ensures good communication and collaboration between all internal and external customers, while at the same time ensures that all Pharmacovigilance standards are maintained;

10.Keep good communication with Health Authorities during PV operation;

11.Finish the work assigned by the supervisor.

任职条件:

岗位要求:

1.至少5年制药行业药物警戒经验;

2.熟悉药物警戒相关法规;

3.熟悉药物警戒数据库系统操作,例如:Argus系统,Arisg系统等;

4.本科及以上;

5.医学、药学、公共卫生或流行病学专业;

6.有临床培训和实践经验者优先;

7.良好的英语听说读写能力;

Basic Requirements:

1.At least 5 years of PV experience in the pharmaceutical industry;

2.Ideally knowledgeable in Pharmacovigilance relevant regulations;

3.Familiar with PV database practice, such as Argus, ARISg, etc.;

4.Bachelor degree or above;

5.Major in medical, pharmacy, public health or epidemiology;

6.Prefer with clinical training and practice experience;

7.Good English skills on both oral and written;

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