上海招聘

Role Title 职位名称：Drug Safety Associate(for spontaneous PV)

Report to上司职位：Drug Safety Manager

Location 驻地：Shanghai

Role Purpose 职位目标：

Strongly oversee safety system of clinical study and spontaneous to prevent safety issue and keep compliance with policy/sop/local regulations, make deep complication with SFDA and Global pharmacovigilance team.

Key Accountabilities/Responsibilities 主要工作职责：

1、Collection of adverse events (AEs), recording in the country register and reporting of AE s to Central Safety Depts.

2、Timely reporting of AEs/SAEs to the local regulatory authority as required

3、Keep contact with GCSP/CR team/Inv./EC/SFDA to make sure safety system work well and compliance with relevant SOPs/Regulations/GCP.

4、Submission of PSURs and other periodic safety updates to Regulatory Authorities, Investigators and Ethics Committees as required.

5、Review protocol/CRF/CSR of local sponsored study and CSP of GSK Supported Study to make sure relevant content is compliance with SOPs/Regulations/GCP.

6、Training of all operating company staff in AE reporting.

7、Deal with compensation.

8、Perform Due Diligence and compliance management.

Qualifications/Requirements: (Education/Experience/Competencies)

申请资格/职位要求/：（教育背景/工作经验/知识与技能）

1、Medical or pharmacy bachelor degree or above.

2、Previous experience in clinical medicine or pharmaceutical,

3、Better have pharmacovigilance related working experience

4、Good at team work and English.

葛兰素史克是最早在中国大规模投资研发领域的国际制药公司之一，通过与中国政府、学术机构和医疗专家保持密切的合作，致力于提高中国人民的健康水平。在进入中国的20多年间，我们在国内的药物研发和临床研究方面已投入了10亿元人民币。我们的目标是使中国成为葛兰素史克全球研发体系中一个重要的战略中心。