Sathish Babu Jayaraman
Senior Manager, Drug Safety Center @ICON plc
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WORK HISTORY
Senior Manager, Drug Safety Center @ICON plc
Mannheim, DE
EDUCATION
The University of Law
Master's degree, Strategic Business Management
Tamilnadu Government Dental College, Chennai
Bachelor’s Degree, Dental Surgery
ABOUT SATHISH BABU JAYARAMAN
An expert drug safety and pharmacovigilance professional with total 12 years of experience in handling adverse event reports and 10 years of managing pharmacovigilance projects with 100+ resources including physicians, pharmacists and health care professionals. Additional working experience in Signal Detection and writing Aggregate Reporting narratives to compile in PSUR’s, PBRER and PADER’s. Leading multiple accounts and delivering projects as per the Service level agreements for leading pharmaceutical companies like Bristol Myers Squibb, Boehringer Ingelheim, Astellas pharmaceuticals and Vifor pharma. High Knowledge and expertise in submitting the cases to regulatory authorities like FDA, MHRA, PMDA, Health Canada, EMEA, BfArM etc with thorough knowledge in Case processing databases like Argus, Aris G, CARES etc. Excellent exposure in writing, editing and approving RCA, CAPA for process related issues and exposure to writing of Medical Evaluation Comments for single case processing. Conducted many training sessions and attended conferences on general clinical research and pharmacovigilance guidelines.
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