Dharmesh Walia

About Dharmesh Walia

Techno-functional, Strategic, and results-oriented Business Delivery Leader with 15+ years of experience in pharmacovigilance, supporting business development activities- Specialized expertise in- ICSR case management and automation - Literature surveillance - PSMF - Compliance reporting - Managed services - PV change management (system validations, audit & inspection support)- PV analytics tools - Database migration and customization- Proven track record of designing and delivering full-service models incorporating advanced technologies (NLP, OCR, algorithm-based data ingestion, secure API) integration)- Skilled in managing complex global PV workflows, ensuring regulatory compliance, and delivering transformation initiatives.

Experience

1. Deputy General Manager

   Cognizant

   Oct 2025 — Present · Gurugram, IN

   Delivery & Business Development Leadership• Proposal & Business Development: Led the development of RFP/RFI responses, including client requirement analysis, solution design, and budget creation for global PV services. Drafted and negotiated SOWs, MSAs, and contracts, ensuring regulatory and financial compliance. • Collaborated with technical and delivery teams to showcase service capabilities and automation solutions.• Supported bid defense and client engagements, contributing to successful business wins and account growth• Delivery Leadership: Lead global pharmacovigilance programs with full operational ownership across cross-regional teams. Scope of responsibility spans:• End-to-end ICSR case management and automation• Global biomedical literature surveillance and API integration• Affiliate and partner reconciliation activities• Oversight of PSMF data updates within Grape system• Vendor governance and KPI-based performance oversight• Strategic collaboration with IT and automation teams, Database customization, ML, NLP, OCR and algorithm-based auto data entry. • Support for PSUR, DSUR, PADER, and other PV deliverables• Global Program Oversight: Directed large-scale service delivery models with a strong emphasis on quality, compliance, and cost efficiency. Regularly engaged with QPPVs, local regulatory representatives, and senior client stakeholders to ensure alignment with global safety requirements.• Audit & Inspection Preparedness.• Regulatory Compliance & PSMF Management.• Training & Regulatory Readiness.• Quality System Management Ownership.• SOP Governance & Best Practices implementation.• Technical Strategy & Automation Partnership: Database configurations, triage workflows, and ML-powered automations (e.g, data entry automation, algorithm-based intake, literature NLP/OCR, and UAT testing support).• Resource & Risk Management.• Team & Leadership Development.• Client Engagement & Growth.

Education

• Indian Institute of Management Rohtak

  Executive Program in Lean Operations Management & Six Sigma

• ICFAI University

  Master of Business Administration - MBA

• Maharshi Dayanand University

  Bachelor of Pharmacy - BPharm, PHARMACEUTICALS

  2006 — 2010

Skills

• Sas
• E2b
• Life Sciences
• Dictionaries
• Mechanism of Action
• Argus Safety
• Word Sense Disambiguation
• Clinical Development
• Sentiment Analysis
• Clinical Research
• Adverse Event Reporting
• Language Processing
• Safety Monitoring
• Edc
• Adverse Events
• Ich-Gcp
• Natural Language Understanding
• Regulatory Affairs
• Lifesciences
• Clinical Trials
• Sop
• Fda
• Drug Safety
• Database Administration
• CRO
• Pharmacovigilance
• Meddra