PV physician

面议

市辖区

刷新时间：2022-08-15

职位描述

Role Title: PV Physician
Reporting to: PV Director
Organization Unit/Country: Reistone Biopharma,Shanghai, China
Role Purpose Statement (how does the role impact business achievements?):
Provide Medical review of adverse event reports for investigational products. Provide input to clincial development plans and clinical trial programs
Main Accountabilities
1.Preparation Development Update Safety Reports
2.Analyses of case reports and aggregate reports for special issues
3.Medical review of ICSR
4.Develop and maintain benefit/risk evaluations
5.Generate and maintain Core Safety Information in CCDS and provide documentation for Labelling Committee
6.Provide input to development programs and and provide Medical review of Study protocol and reports
7.Generate and maintain Risk Management Plans
8.Provide input to process development within area of responsibility
9.Monitoring of safety in clinical trials including chairing/co-chairing Data Safety Monitoring Boards, Safety Committees
10.Keep updated on legislation within the Pharmacovigilance area
11.Reply to questions and queries regarding safety issues with Reistone products
12.Ad-hoc safety and risk assessments
13.Develop and update role relevant SOPs
14.Provide drug safety trainings to relevant stakeholders
Role related Qualifications/ Skills:
1.Medical degree
2.3+ years’ experience from international pharmaceutical industry and drug development preferred
3.Strict ethics
4.Fluency in EnglishProficient in regulatory guidance and legislation&nbs*****>

其他要求

招聘人数：3人
职能类别：药物安全/药物警戒PV

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。