Pharmacovigilance Associate

• Data Retrieval: Gather and prepare data for authoring specific sections of Periodic Safety Update Reports (PSURs).
• Quality Control: Review and ensure the accuracy of data retrieval processes and selected PSUR sections.
• PSUR Finalization: Finalize PSURs, including creating the final PSUR PDFs.
• Regulatory Responses: Draft responses to requests from regulatory agencies as needed.
• Compliance: Ensure that all PSUR-related activities are performed according to established procedures.
• Collaboration: Work closely with other functions within Teva to support your role.

Qualifications

• Education: 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 attention to compliance and deadlines.

Reports To

• Position: PV Manager, Aggregate Reports Expert