- 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
- Knowledge of general case processing and expedited reporting activities
- 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.
- Knowledge and experience of CIOMS, GVP, FDA and ICH guidelines Understanding of AESI, CMEs, DMEs, and activities surrounding these topics
- Project management activities.
- Other (such as submissions support, launch activities, etc.,)
- At least 6 years in drug safety/pharmacovigilance, including experience with case review/processing. Early and post-marketing experience
- Working experience in a Global environment
- Experience with oncology drugs
- Communication; clearly express ideas/position
- English business fluent