PV physician

面议

上海市

刷新时间：2022-10-24

职位描述

 • Lead Sinovent’s Pharmacovigilance China team with processing of adverse event/drug experience reports (serious and non-serious) and other safety related data for Sinovent’s marketed products and clinical trials to ensure high quality case reports and submissions compliance
• Provide functional oversight over clinical trial and post-marketing pharmacovigilance processes
• Assist to direct project start-up team to ensure timely and accurate completion of start-up tasks including review of study documents, reports, marketing brochures, and others as applicable
• Set up case processing process for clinical trials including consultation with NMPA and coordination with CRO
• Maintain PV database including system update according to Sinovent’s strategy and international regulation
• Provide in-depth technical expertise on Sinovent’s Pharmacovigilance processes and systems
• Assist with directing CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes
• Assist to support audit and inspection processes as required, including serving as functional subject matter expert as required
• Manage resource management processes for assigned teams, including recruitment of staff, line management of assigned staff and succession planning
• Ensure compliance with Pharmacovigilance data reconciliation processes, and work to resolve/escalate issues as appropriate
• Develop procedures (SOPs, Job Aids), forms and templates in support of efficient case management processes
• Develop staff in assigned functional Pharmacovigilance processes, project and team management, and encourage growth by provision of regular mentoring and performance feedback
• Assist with vendor oversight, including identification of out of scope needs, quality and resourcing issues, and escalation of issues as appropriate
• Direct and ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times
• Ensure files and systems are maintained as appropriate
• Oversight and direction of additional tasks and projects as assigned by senior management
• Support Senior Management as required.

其他要求

招聘人数：2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。