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High Salary) Pharmacovigilance Associate
4 weeks ago
- 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
