Drug Safety Specialist (50%) (m/f)

REFERENZNUMMER:

331279/11

IHRE AUFGABEN:

-Set up and maintain safety process for assigned clinical studies (e.g. safety management plan, reconciliation)
-Case processing activities from clinical studies and post-marketing experience
-Manage updates and revisions of safety data exchange agreements (SDEA) and be involved in the preparation of new SDEAs
-Preparation of aggregate safety reports (DSUR, PSUR)
-Be involved in updates of PV SOPs and of processes at safety CRO
-Maintenance of the pharmacovigilance system master file (PSMF)
-Ensure that all adverse event reports are processed according to SOPs
-Filing and archiving of relevant safety information as required

IHRE QUALIFIKATIONEN:

-Advanced degree in Life Sciences (Minimum Bachelor)
-Solid experience in pharmacovigilance/drug safety, ideally at headquarters level
-Used to interact with other departments (e.g. Clinical Development, Regulatory Affairs)
-Fluent in English (verbal and written), other languages are of advantage (e.g. French, German, Italian)
-Working knowledge of EU pharmacovigilance requirements for investigational and marketed compounds
-MS Word, Excel, PowerPoint skills
-Good written and verbal communication skills

WEITERE QUALIFIKATIONEN:

Drug safety assistant