Richa Singhal

Background

About Richa Singhal

Overall experience of 18 years in the field of life sciences pertaining to safety and clinical products that includes ArisG LSMV, Oracle Argus Safety, Quadrants (PV Retrospective Quality Tool), PEI (PV Case Intake), Oracle Life Sciences Data Hub (LSH), Labpass, Clear Trial, Clinical Data Management, Clinical Development Center (CDC), Inform, DMW, and EDC. • Rich technical and functional experience in Argus Safety System • Deep experience in managing product safety requirements, market analysis, product adoption, and integrating with product development organization. Define and discover the minimum viable product (MVP) • Extensive Experience in Requirement gathering for safety products and compliance reports with different stakeholders like LSOs, Case Processing Vendors, head of safety operations and other PV users • Participated in RFP finalization and vendor selection processes for various customers • Working as a Product owner for PV case intake, a web-based tool to manage ICSRs, related communications via Queries and reports that are submitted to Local Authority • Detailing Requirements and provide solutions to PV users on how to manage case processing • Trained LSOs, case processing vendors and other PV users on Argus Safety System • Experience with Regulatory Authorities Audit • Certified Product owner with responsibilities including creating product backlog, running grooming, planning and sprint review sessions • Well versed in Onshore-Offshore model. Good Understanding of Client-Relationship Management, SLAs. Well versed in handling both T&M and Fixed bid projects. • Rich Technical and functional experience in Clinical system and processes, implementation and validation of safety and clinical products. • Having strong experience in development, maintenance, data migration, system validation, business mapping using SDTM and implementation of SDTM mappings to Clinical trial data. • Good exposures to Oracle backend for performing Database Developer tasks, worked with database- procedures, functions, packages, and database triggers. Having a good exposure to code review mechanisms and coding standards. • Excellent communication, documentation, analytical and presentation skills.