SAURABH PANDEY
Mississauga,ON
Summary
Seasoned PV Consultant and Program Manager with over 12 years of experience in the pharmaceutical industry. Expert in utilizing cognitive AI and automation tools to enhance operational efficiency. Proven track record in managing Pharmacovigilance products, including AI automation, Regulatory analytics, Argus, PV Monitor, and ARISG/J. Adept at authoring validation documents (OQ, PQ, IQs) and working closely with business stakeholders to define, document, and improve business requirements for projects and process enhancements.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Senior Lead Consultant
Birlasoft Technologies for Johnson and Johnson
Mississauga, Ontario
03.2020 - Current
- Develop and execute detailed Project Plans; lead project teams with effective communication.
- Conduct stakeholder interviews to gather requirements and translate customer needs into tailored solutions.
- Manage JIRA for User Stories & Test Executions, overseeing validation plans and bug tracking.
- Perform IQ, QQ and PQ testing, System Testing, and provide UAT support.
- Prepare project proposals and statements of work.
- Communicate project timelines and technical limitations; analyze KPIs and manage risk.
- Facilitate Design thinking workshops; manage product backlog and prioritize tasks.
- Conduct Scrum Ceremonies efficiently and improve validation efficiency through scripting/coding.
- Ensure GxP data privacy and regulatory compliance.
Senior Consultant
IQVIA
Noida, Uttar Pradesh
07.2012 - 03.2020
- Consulted pharmaceutical clients like Sanofi, Bayer, and Novartis, Astellas, Abbott on implementing and integrating drug safety applications such as Argus, ArisG and other PV tools.
- Identified and advised on process improvements, managed project progress, and facilitated cross-functional team collaboration.
- Led development and execution of OQ, PQ, and IQ scripts; end-to-end GxP validation processes and managed related documentation.
- Coordinated with product teams for issue resolution, change control, and SLA management using ServiceNow and JIRA.
- Delivered L1, L2 and Hypercare support, including impact analysis, testing, and configuration management.
Application Support Engineer
Aris Global Software Pvt. Ltd.
Bangalore, Karnataka
10.2011 - 07.2012
- Managed incident tickets and provided support to Japanese pharmaceutical companies, including Celgene and Seikagaku.
- Conducted QA, executed OQ/PQ for ARISj Safety, and tested ARISj/g.
- Troubleshooted Drug Safety application issues, identified and reported defects through ServiceDesk.
- Liaised with clients, updated documentation, and collaborated with developers.
Education
Bachelor of Technology - Electronics & Communications Engineering
Rajasthan Technical University
Kota, Rajasthan, India01.2011
Skills
- Project Management
- Requirements Gathering
- JIRA Enterprise & X-Ray
- CSV & GxP Risk Assessment
- Validation Testing (OQ, PQ, IQ, UAT)
- Agile Software Development Lifecycle
- Vendor Relationship & Strategic Planning
- Strategic Decision-Making
- Incident & Change management
- Resource Management
Certification
Certified ScrumMaster®(CSM®), Credential ID 1739324, Badge: https://bcert.me/skvsmosdt
Certified Scrum Product Owner®(CSPO®), Credential ID 1815853, Badge: https://bcert.me/szgdfnhdm
Timeline
Senior Lead Consultant
Birlasoft Technologies for Johnson and Johnson
03.2020 - Current
Senior Consultant
IQVIA
07.2012 - 03.2020
Application Support Engineer
Aris Global Software Pvt. Ltd.
10.2011 - 07.2012
Bachelor of Technology - Electronics & Communications Engineering
Rajasthan Technical University
Certified ScrumMaster®(CSM®), Credential ID 1739324, Badge: https://bcert.me/skvsmosdt
Certified Scrum Product Owner®(CSPO®), Credential ID 1815853, Badge: https://bcert.me/szgdfnhdm
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