Archiviertes Projekt - Projektmanager Drug Safey (m/f/d)

Ihre Aufgaben:
• 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.,)

Ihre Qualifikationen:
• 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
• English

Ihre Vorteile:
Varied tasks in a renowned company

Projektdauer: 12 MM++


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