DSUR, PBRER and pSUSAR preparation/project management/ writing up
Literature review processes; be able to understand the publications and highlight potential signals or important efficacy information
Safety data review using spotfire or other visualization tool at clinical level and for integrated data
Use ArisG or other safety databases to generate CIOMS and/or review
Surveillance related project management activities (slide preparation for safety committees and boards, meeting minutes., etc)
Safety evaluation report writing by applying principles such as Bradford Hill criteria, CTCAE etc.,
Project management activities.
Other (such as submissions support, launch activities etc.,)
Experience with Drug Safety
Experience with PSUR, DSUR
Knowledge of general case processing and expedited reporting activities
Knowledge and experience of CIOMS, GVP, FDA and ICH guidelines
Understanding of AESI, CMEs , DMEs and activities surrounding these topics
Varied tasks in a renowned company
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