SAURABH PUROHIT
Cambridge,USA
Summary
Accomplished pharmacovigilance professional with over 19 years of industry experience, including 17 years in pharmacovigilance operations and quality assurance. Currently serving as an Onsite Program Manager since June 2022, contributing to a $19.5 million pharmacovigilance engagement. Expertise in scaling global pharmacovigilance programs, ensuring regulatory compliance, and enhancing operational efficiency while delivering strategic insights on resource planning, forecasting, margin optimization, and profit and loss considerations. Committed to driving excellence in pharmacovigilance through innovative solutions and a proactive approach to risk management.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Onsite Program Manager (PV)
Cognizant Technology Solutions
06.2022 - Current
- Oversee a $19.5M pharmacovigilance program spanning multiple therapeutic areas; manage end-to-end PV operations and governance. Provide strategic inputs on resourcing, forecasting, and margin optimization to support financial performance while maintaining regulatory compliance and service excellence. Coordinate delivery across a team of 650+ PV professionals—including managers, team leads, and trainers.
- Sustained 99% case submission compliance across 300,000+ cases annually.
- Managed major process integrations with zero impact on compliance, SLAs, or submission timelines.
- Prepared and responded to global audits/inspections (FDA, EMA, MHRA, Health Canada) with effective CAPA, strengthening QMS.
- Implemented governance and continuous-improvement initiatives that streamlined workflows and reduced operational risk.
- Led project-level BQA activities—authoring SOPs/project documents, conducting FMEA/risk assessments, and preparing teams for audits and inspections.
Service Delivery Manager (Pharmacovigilance)
Cognizant Technology Solutions
10.2016 - 05.2022
- Oversaw PV case processing, partner reconciliation, MR/PSPs, and QA across diverse portfolios. Served as the interface between client stakeholders and internal leadership; aligned delivery to SLAs/KPIs and drove operational excellence.
- Directed day-to-day ICSR case processing for >9,000 cases/month, ensuring timely submissions across safety databases.
- Maintained 100% regulatory and partner compliance for three consecutive years; sustained >99% monthly case submission compliance in high-volume programs.
- Managed internal/external audits and inspections; strengthened SOPs, document control, and CAPA effectiveness.
- Led process transitions (client↔vendor, vendor↔vendor) using Agile/Lean/Six Sigma methodologies; executed change-management plans.
Manager, PV-QA
Lambda Therapeutics Ltd.
04.2016 - 10.2016
- Managed PV-QA operations; identified process gaps and coordinated resolutions. Produced monthly PV quality reports for the Quality Review Board; conducted SDEA partner/vendor audits; enhanced document control; maintained PSMF and SDEAs.
- Ensured compliance monitoring for ICSRs, PSURs/PBRERs, and RMPs; owned inspection readiness and contract management.
Senior PV Specialist (Global Compliance Monitoring)
PAREXEL International
04.2011 - 04.2016
- Executed literature QC/QA; ensured compliance with company and regulatory requirements. Investigated late metrics and PSUR/PBRER delays with RCA and CAPA on PV Monitor; maintained audit-ready data integrity.
- Delivered PV Monitor training to global affiliates; mentored QA scientists and new staff.
- Supported case validity assessments and ADRF creation; liaised with client quality teams for data analysis and process improvement.
Education
Master of Pharmacy - Pharmaceutical Chemistry
Poona College of Pharmacy
Pune, India01.2007
Bachelor of Pharmacy - undefined
Smriti College
Indore, India01.2005
Skills
- PV Safety Systems & Case Processing Platforms
- Compliance Monitoring & KPI Dashboards
- Audit/Inspection Management & CAPA
- SOP/Document Control
- Issue resolution
- Cross-functional coordination
Certification
- Lean Six Sigma in Operations Management
- Diploma in Intellectual Property — World Intellectual Property Organization (WIPO)
Languages
English
Hindi
Timeline
Onsite Program Manager (PV)
Cognizant Technology Solutions
06.2022 - Current
Service Delivery Manager (Pharmacovigilance)
Cognizant Technology Solutions
10.2016 - 05.2022
Manager, PV-QA
Lambda Therapeutics Ltd.
04.2016 - 10.2016
Senior PV Specialist (Global Compliance Monitoring)
PAREXEL International
04.2011 - 04.2016
Bachelor of Pharmacy - undefined
Smriti College
Master of Pharmacy - Pharmaceutical Chemistry
Poona College of Pharmacy