Nrupali G.

About Nrupali G.

PROFESSIONAL SUMMARY An experienced Sr. Director of Pharmacovigilance Operations and…

Experience

1. Senior Director, Pharmacovigilance Operations

   Summit Therapeutics, Inc.

   Mar 2023 — Present

   Set up and negotiate the GSP, with a consistent approach for each drug (candidate) • Facilitate all PV operations aspects with vendors and collaborators • Handle negotiations and provide expertise to the PV component of contracts/agreements with third parties to ensure quality and integrity of agreements. • Lead Vendor oversight activities • Lead the strategy for proactive PV and risk management planning of our development product • Lead negotiations and provide expertise for all PV aspects of contracts/agreements with third parties to ensure quality and integrity of agreements. • Reporting of safety metrics to appropriately manage business risks, and to enable management to monitor the compliance and the success of the pharmacovigilance (PV) operating model. • Lead safety strategy for regulatory submissions of new products, or indications (NDA/BLA, MAA) with the GSP and other functional specialists. • Take accountability and lead resolution of safety issues and mediate cross-functional agreement. • Drive improvements for the operational aspects of PV as part of the digital and data-analytics approach. • Oversee and manage PV process and SOPs • Lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organization. • Lead safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines. • Take accountability and lead resolution of safety issues and mediate cross-functional agreement. • Provide training and mentorship to new GSPs and PV staff in approved processes and systems.