Pharma Safety Consulting

* DSUR, PBRER and pSUSAR preparation, project management and 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

VORAUSSETZUNGEN:

Remote-part: 80%

* At least 6 years in drug safety or pharmacovigilance, including experience with case review and processing
* Early and post-marketing experience
* Working experience in a Global environment
* Experience with oncology drugs
* Communication and clearly in expressing ideas
* English business fluent, German nice to have