QA Medical Reviewer
4 days ago
Role & responsibilities
• Analysis, case intake and processing of adverse events from diverse therapy areas in to clients safety systems, ensuring 100% accuracy by conforming to the SOPs
- Lay strong emphasis on quality, ensuring zero errors during all steps of ICSR processing
- Proficient in end to end case processing. Activities include : Data verification , Data entry , coding of adverse events and drugs , causality assessments , case narratives and quality assessments
- Exposure and proficient in working in ARISg and IRT / Argus/ any other safety databases
- Lay strong emphasis on quality, ensuring zero errors during execution and/or review of comments while analyzing adverse events
- Coordinate effectively with team members and stakeholders
- Ability to train other team members on case processing concepts / practices
Preferred candidate profile
1-3 years of relevant work experience or clinical research organizations experience
Familiarity with workflows in PV safety databases/tools
- Basic knowledge and understanding of the pharmaceutical regulations (FDA/EMA) and standards (ICH)
- Computer proficiency (MS Office)
- Bachelor of Medicine, Bachelor of Surgery (MBBS) / Bachelor of Dental Surgery (BDS) / BSc in Nursing / B Pharm / M. Pharm or any other relevant degree from a reputed university
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