职位描述:
1、Collect, tralate, report, and follow up post-marketing AEs from all sources to central safety team and CFDA in timely manner.
2、 Collect, tralate, report, and follow up clinical study SAE to central safety team and CFDA in timely manner.
3、Distribute Safety Information, e.g. PSRI,INDSR and MSRI to study team onward to Investigato and ECs.
4、Submit periodic reports including Periodic Safety Update Report, and oveea Monthly Serious Advee Drug Reaction Line Listings to CFDA in timely manner.
5、Literature review to identify reportable AEs.
6、Provide drug safety related training to internal and external stakeholder.
7、Manage PV related documentatio appropriately.
8、Back up to other Safety Associate when required.
9、Perform other PV related tasks when required.
Basic Requirements:
1.Bachelo degree or above in clinical medicine, pharmacy or a life/biological science
2.Good interpeonal communication skill
3.Good command of both English (written and spoken) and Chinese (written and spoken)
4.Good computer skills including proficiency with Microsoft Word, Explorer and Outlook and familiarity with the internet
5.Good at teamwork