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• Data retrieval for authoring and preparation of selected PSUR sections.
• Review/QC of the data retrieval procedure and selected PSUR sections.
• PSUR finalization (creation of PSUR pdf).
• Drafting responses to requests from regulatory agencies, as required.
• Making sure assigned PSUR-related activities are performed in line with working procedures.
• Collaborative working relationships with other functions in Teva.
• University degree (B.Pharm, M.Pharm, Pharm.D)
• Active knowledge in English, both written and spoken
• Working experience with databases (e.g. ARISg, Argus, Cognos, Veeva, TrackWise, QlikSense)
• MS Office skills (Word, Excel, PowerPoint)
• Minimum 1-2 years of experience in Pharmacovigilance (PSUR/RMP/PADER writing or ICSR/case processing writing)
• Strong sense for compliance and deadlines.
PV Manager, Aggregate reports expert
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