Sumith Harindranath
Associate Director, Pharmacovigilance Sciences
- Role
- Associate Director, Pv Sciences at Taiho Oncology, Inc.
- Location
- Princeton, NJ, US
- LinkedIn followers
- 500 followers
About Sumith Harindranath
An experienced Drug Safety/Pharmacovigilance/Regulatory Writing professional with 12 plus years of relevant experience with top pharma/biotechnology firms worldwide. Significant experience in authoring and review of all safety regulatory document types (e.g, PSUR/PBRER, DSUR, PADER, CAR, ACO, RMP etc. and ad hoc safety responses to various Drug Regulatory Authorities).Quality Control of CSRs, IB, briefing documents, RTQ’s, RMP’s, REMS, PRAC RTQ’s, Safety Assessment Reports and clinical overview documents.Signal Detection Activities: Assist Safety Risk Lead in analyzing safety signal data retrieved from the signal detection tool and literature review and discuss the results with the TAH, SRL, and other key stakeholders.Mentoring, training and coaching new employees on ICH regulations and company SOPs. Business process improvement: Developed QC score card: tool for RCA and CAPAHands on expertise on various drug safety databases such as Argus, ArisG, Sapphire and tools such as Pfast (Pfizer Analytical and Statistical Tool), EPIC and GDMS. Proficient in MedDRA coding, ICSR (including medico-legal case) processing and narrative writing.Lean Six Sigma Green Belt trained professional adept at applying the principles of Six Sigma. Actively involved in Project management related activities including TCS Integrated Quality Management System.Ambitious, self-motivated individual with problem solving abilities and excellent communication skills. Ability to influence people, proven interpersonal skills and analytical thinking. Thorough, structured and strong organizational skills and ability to multi-task
Experience
Associate Director, Pv Sciences
Jan 2025 — Present · Princeton, NJ, US
Education
Northeastern University
Master's degree, Project Management
Tamil Nadu Dr. M.G.R. Medical University , Chennai
Bachelor of Dental Surgery, BDS, Dentistry
2000 — 2006
New England College
Master of Science - MS, Medical Informatics
Institute of Clinical Research India
Post-Graduate Certificate in Clinical Research, Clinical Research
2008 — 2009
Newcastle University
MBA, General MBA
2011 — 2012
Indian School Muscat
CBSE, Xth
1997 — 1998
Matha Senior Secondary School, Kerala
Central Board of Secondary Education (CBSE), XI-XII
1998 — 2000
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