Rithika Shaw

Technology Lead @Infosys

Toronto, ON, CA
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Nov 2025 — Present

Technology Lead @Infosys

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Toronto, ON, CA

Business Analyst – Design Lead• Led multi-workstream discovery and business analysis for a global pharmaceutical client. Delivered current-state insights, identified strategic gaps and opportunities for enterprise transformation.• Facilitated stakeholder alignment, requirements definition across cross-functional teams, enabling operational and quality process improvements.

EDUCATION

N/A

Osmania University

Bachelor of Applied Science - BASc

2019 — 2020

University of Toronto

Data Science Certificate

N/A

Cranfield University

Master of Science - MS

SKILLS

HealthcareArisgMeddraU.s. Food and Drug Administration (Fda)CROTeam ManagementMicrosoft OfficeIcsr Narrative WritingGcpGood Clinical Practice (Gcp)Electronic Common Technical Document (Ectd)LeadershipClinical TrialsIcsrImedidataRegulatory AffairsDatalabsAdverse Event ReportingProject PlanningEuropean Medicines AgencyClinical ResearchIch-GcpProject ManagementSignal DetectionClinical Data ManagementPharmaceutical IndustryDrug SafetyEdcAdverse EventsArgus SafetyWhodraPharmacovigilance

ABOUT RITHIKA SHAW

I operate at the intersection of product ownership, business analysis, and regulatory innovation, bringing 11+ years of experience across pharmacovigilance operations, regulatory systems, and early-stage drug development.I design scalable, adoption-focused solutions that translate domain complexity into system clarity. Whether it’s streamlining safety content workflows, enabling intelligent automation in regulatory planning, or expanding scientific data pipelines, I work closely with senior leadership, business and technical stakeholders, and users to bridge gaps before they become pain points.My experience spans global programs in vaccine surveillance, oncology, rare diseases, and early-phase research always with a focus on user-centric innovation in compliance-bound environments.Core Competencies:Product Ownership & Agile DeliveryVeeva Vault RIM & Regulatory Content ManagementScientific Data Integration & GovernanceSafety Reporting (DSUR, PBRER, RMP, aCO, PADER, SSR, Safety Communication)Sprint Planning, Story Grooming & Release ManagementRFC Authoring & Requirements ManagementProcess Mapping, SOPs & Workflow DesignWorkshop Facilitation, Stakeholder Alignment & TrainingI bring systems to life with a balance of domain insight, delivery discipline, and a strong bias toward usable, forward-looking solutions.

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Rithika Shaw — Technology Lead at Infosys in Toronto, ON, CA | Unifers