Naveen Shekhawat
Drug Safety, PV IT Project Management, Tech Enthusiast, GxP, CSV Specialist, Veeva Vault Safety, Argus Upgrades
- Role
- Senior Director at Pinnaxis
- Location
- Jaipur, RJ, IN
- LinkedIn followers
- 500 followers
About Naveen Shekhawat
Naveen is the Senior Director of Professional Services at Pinnaxis IT Consulting and Solutions Pvt. Ltd. Naveen is responsible for project delivery stretched across multiple platforms like Veeva Safety, Oracle Argus. Prior to Pinnaxis, Naveen, as the Associate Director in Drug Safety at Novartis Pharma\'s Technology Transformation team. In this role, Naveen was responsible for managing the projects in Safety domain like M&A, upgrades etc. Also, he acted as Technical Design Expert, he was responsible for technical design and solutioning aspects, like code reviews, reviewing Design specs etc.In Naveen\'s earlier role as IT Project Manager for Sun Pharma wherein he was responsible for new implementations and upkeep of existing systems for Pharmacovigilance and Regulatory Affairs teams. Naveen used to work with internal and external stakeholders to deliver projects in the highly regulated GxP domain. He is also responsible for and leads IT responses in regulatory audits. He also leads implementations on the public cloud for GxP applications. Prior to Sun, Naveen has worked with IQVIA, he was responsible for the Validation of software systems in the Pharmacovigilance domain. During this period he worked with varied Healthcare and Lifesciences companies ranging from the worlds\' top Pharma companies to top CROs. He also led multiple teams simultaneously to deliver high-quality projects.In his earlier roles, he has been involved with an Indian IT service major to work on medical device validation and SAP validations.
Experience
Senior Director
Feb 2025 — Present · Noida, IN
Education
University of Rajasthan
Bachelor of Engineering (B.E.), Computer Science
2004 — 2008
Skills
- Regulatory Requirements
- Clinical Trials
- U.s. Title 21 Cfr Part 11 Regulation
- Software Documentation
- Sdlc
- 21 Cfr Part 11
- Quality System
- Test Planning
- Validator
- Gamp
- Testing
- Life Sciences
- Requirements Analysis
- Validation
- Gxp
- Lims
- Quality Auditing
- Pharmacovigilance
- Quality Control
- Gmp
- Software Development Life Cycle (Sdlc)
- Documentation
- Gap Analysis
- Pharmaceutical Industry
- Sop
- Fda
- Drug Safety
- Hp Quality Center
- Compliance
- Quality Assurance
- Change Control
- Computer System Validation
- Argus Safety
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