
Pharmacovigilance Associate
3 weeks ago
- 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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