Data Retrieval:
Retrieve and prepare data for authoring selected Periodic Safety Update Reports (PSURs).
Review and Quality Control:
Review and perform quality control on the data retrieval procedures and selected PSUR sections.
PSUR Finalization:
Finalize PSURs, including the creation of PSUR PDFs.
Regulatory Responses:
Draft responses to requests from regulatory agencies as needed.
Compliance:
Ensure all PSUR-related activities are conducted in accordance with established procedures.
Collaboration:
Foster collaborative relationships with other functions within Teva.
Additional Tasks:
Perform other tasks as assigned by your direct manager.

Qualifications

Educational Background:
University degree in Pharmacy (B.Pharm, M.Pharm, Pharm.D).
Language Skills:
Proficiency in English, both written and spoken.
Technical Skills:
Experience with databases such as ARISg, Argus, Cognos, Veeva, TrackWise, QlikSense, and proficiency in MS Office (Word, Excel, PowerPoint).
Experience:
Minimum 1-2 years in Pharmacovigilance, with experience in PSUR/RMP/PADER writing or ICSR/case processing writing.
Skills:
Strong sense of compliance and ability to meet deadlines.

Reports To

Position:
PV Manager, Aggregate Reports Expert

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