Praveen T
Drug Safety Analyst @Synergyassure
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WORK HISTORY
Drug Safety Analyst @Synergyassure
Chicago, IL, US
Oversee daily ICSR quality review, including narratives, medical coding, and case discrepancies, while managing follow-up queries and regulatory report evaluations.* Conduct SAE reconciliations with CROs, vendors, and partners, providing safety guidance and addressing inquiries related to case processing and reconciliation activities.* Lead user acceptance testing in Oracle safety databases, ensuring data entry changes meet standards before production.* Facilitate signal detection, literature surveillance, and create/revise PV SOPs, agreements, and work instructions, ensuring compliance with regulatory requirements.* Ensure audit readiness, support regulatory inspections, and deliver case processing and protocol training to vendors.
EDUCATION
Andhra University, Visakhapatnam
Doctor of Pharmacy
Indiana University–Purdue University Indianapolis
Master's degree
ABOUT PRAVEEN T
As a Pharmacovigilance and Health Informatics professional with over 8 years of…
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