Saurabh Tiwari
Periodic Planning Expert Oversight @IQVIA
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WORK HISTORY
Periodic Planning Expert Oversight @IQVIA
Bengaluru, IN
Expertise on the regulatory framework and is the process owner for Global PSRs (e.g. PBRERs, Semi Annual Safety Reports {SASR}, DSURs, Product renewals (Addendum for Clinical Overview {ACO}), PADERs, etc.), Provides Global PSR format training to new and contributors, provides mentorship for new PREs, Leads and manages the cross-functional coordination of PSRs and Pharmacovigilance contribution to PSRs to ensure regulatory submission compliance; etc. Responsible for PSR quality and compliance oversight and continuous improvement of processes.
EDUCATION
Vellore Institute of Technology
Master's degree, Applied Microbiology
ABOUT SAURABH TIWARI
8 years of experience in pharmacovigilance, data management, medical information call center, strategy planning, end to end ICSR processing, resource and workflow management. Expertise including complex decision making activities. Specialization in both pre and post marketing drug development and formulation process. Well versed with handling, validation and calibration of various analytical instruments like HPLC, GC,LC-MS-MS, and NMR.
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