Medical Affairs Mgr(欧美独资制药企业，可组建团队)
上海帝博企业管理咨询有限公司
- 公司规模：少于50人
- 公司性质：外资(欧美)
- 公司行业：专业服务(咨询、人力资源、财会)
职位信息
- 发布日期：2013-06-20
- 工作地点：上海
- 招聘人数：若干
- 职位类别：药品生产/质量管理 生物工程/生物制药
职位描述
Medical Affairs Mgr(欧美独资制药企业，市中心上班，薪资丰厚，可组建团队)
岗位职责：
? Receipt of adverse events and quality complaints received in China. Working in accordance with a local system/ tracking cases. ? Local adverse event/ complaint follow up. ? Facilitating the sending of complaint samples to the APAC RHQ/ manufacturing site. ? Reporting of adverse events and quality complaints received in China to regional headquarters. This will include a translation of the report into English. ? Making local adverse event reportability decisions. ? Reporting adverse events to the local authority in line with local requirements/ compliance timelines. ? Scheduling and reporting PSUR’s/ other aggregate reports to local authority in line with local requirements/ compliance timelines. ? Informing the RHQ of the local pharmacovigilance requirements (both for license submission and post marketing) and ensuring these local requirements are adhered to. ? Delivering safety/ complaint management training to colleagues in the Chinese office/ sales force. Monitoring this activity post training. ? Delivering product/ medical training to colleagues in the Chinese office/ sales force. Monitoring this activity post training. One important training aspect will be clinical training particularly in relation to the oncolytic products. ? Management of local medical information requests/ interacting with the RHQ to ensure correct information is delivered in a timely manner. An important part of this role will involve providing the sales force with product support. ? Maintenance/ ownership of local pharmacovigilance/ complaint management/ medical information processes. ? Acting as the primary contact with the local authorities. ? Monthly reporting to RHQ. ? Local promotional material review. ? Contact person for the SFDA/ MOH
任职资格的具体描述：
Required qualifications ? Science degree or tertiary qualification in health sciences. Desirable Qualifications ? Pharmacy/ medical qualification. ? Post-graduate studies in the science field. Required Experience ? At least three years experience in the pharmaceutical/device industry and a good understanding of the local regulations for the following activities: - Pharmacovigilance - Complaint management - Promotional material review. - Medical information. ? Experience in delivering effective training. ? Communication and computer skills, e.g., scientific writing/presentations, office document software usage, such as Word, Excel, etc. Desirable Experience ? adverse event reporting for clinical trials
公司微博：http://weibo.com/2674989551
公司QQ：1652479807
公司msn：workdbtalent@hotmail.com
岗位职责：
? Receipt of adverse events and quality complaints received in China. Working in accordance with a local system/ tracking cases. ? Local adverse event/ complaint follow up. ? Facilitating the sending of complaint samples to the APAC RHQ/ manufacturing site. ? Reporting of adverse events and quality complaints received in China to regional headquarters. This will include a translation of the report into English. ? Making local adverse event reportability decisions. ? Reporting adverse events to the local authority in line with local requirements/ compliance timelines. ? Scheduling and reporting PSUR’s/ other aggregate reports to local authority in line with local requirements/ compliance timelines. ? Informing the RHQ of the local pharmacovigilance requirements (both for license submission and post marketing) and ensuring these local requirements are adhered to. ? Delivering safety/ complaint management training to colleagues in the Chinese office/ sales force. Monitoring this activity post training. ? Delivering product/ medical training to colleagues in the Chinese office/ sales force. Monitoring this activity post training. One important training aspect will be clinical training particularly in relation to the oncolytic products. ? Management of local medical information requests/ interacting with the RHQ to ensure correct information is delivered in a timely manner. An important part of this role will involve providing the sales force with product support. ? Maintenance/ ownership of local pharmacovigilance/ complaint management/ medical information processes. ? Acting as the primary contact with the local authorities. ? Monthly reporting to RHQ. ? Local promotional material review. ? Contact person for the SFDA/ MOH
任职资格的具体描述：
Required qualifications ? Science degree or tertiary qualification in health sciences. Desirable Qualifications ? Pharmacy/ medical qualification. ? Post-graduate studies in the science field. Required Experience ? At least three years experience in the pharmaceutical/device industry and a good understanding of the local regulations for the following activities: - Pharmacovigilance - Complaint management - Promotional material review. - Medical information. ? Experience in delivering effective training. ? Communication and computer skills, e.g., scientific writing/presentations, office document software usage, such as Word, Excel, etc. Desirable Experience ? adverse event reporting for clinical trials
公司微博：http://weibo.com/2674989551
公司QQ：1652479807
公司msn：workdbtalent@hotmail.com
公司介绍
DB Talent is a European based recruitment company. Our Shanghai office opened in the 2001, and we have continually provided excellent professional service to our clients and candidates.
联系方式
- 联系人：resume
- 电话：13701722965