Pharmacovigilance Associate

• 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