Automated PV Metrics Dashboard
Designed and implemented a dashboard tracking productivity, quality, and compliance across projects — enabling faster leadership decisions and continuous improvement.
AutomationAnalyticsCompliance
Available for select opportunities
Manager · Pharmacovigilance
Ajay Shahi
15+ years building high-performing PV teams, scaling ICSR case processing, and turning safety data into decisions that stick.
At a glance
15+
Years in PV
50
Team members led
5+
PV databases
5
Concurrent projects
Currently Manager, Pharmacovigilance at Cencora — leading global drug-safety operations.
About
Safety operations, at scale — with discipline and calm.
I'm a Pharmacovigilance leader with 13+ years in ICSR management and 5+ years in project management, supporting global drug safety operations across five-plus PV databases. I've led teams of up to 50, delivered up to five concurrent case processing projects, and stayed obsessive about compliance, quality, and timelines. My focus now is designing scalable, data-driven safety operations — and building the teams that run them.
Education
PGDCR, Satrishi Institute of Clinical Research
B.Pharm, NRI Institute of Pharmacy
Languages
Hindi (Native) · English (Professional)
Experience
A timeline of leadership in drug safety.
Manager, Pharmacovigilance
Cencora · NoidaApr 2021 — Present- Lead multi-project PV case processing operations with teams up to 50, consistently meeting compliance, quality, and productivity SLAs.
- Designed an automated dashboard for productivity, quality, and compliance metrics — improving leadership visibility and decision speed.
Assistant Manager
Cencora · Greater Delhi AreaDec 2016 — Mar 2021- Managed up to five concurrent ICSR case processing projects across global clients and multiple PV databases.
- Built operational frameworks for scope, resource allocation, risk mitigation, and stakeholder reporting.
Senior Drug Safety Specialist
Cencora · Greater Delhi AreaDec 2015 — Nov 2016- Handled end-to-end ICSR processing with focus on regulatory compliance and quality standards.
Junior Data Analyst
Cognizant · New Delhi AreaDec 2013 — Nov 2015- Supported drug safety data operations and case processing workflows for global pharma clients.
Pharmacovigilance Officer
Wipro BPS · New Delhi AreaJan 2012 — Nov 2013- Processed ICSRs in line with client SOPs and global regulatory requirements.
Clinical Research Associate
KPS Clinical Services · Greater NoidaMay 2011 — Jan 2012- Supported site monitoring and clinical trial documentation activities.
Production Officer
ZYG Pharma · Indore, MPOct 2008 — Jan 2010- Oversaw production floor operations and batch documentation compliance.
Skills
What I bring to a safety org.
Pharmacovigilance
ICSR ManagementCase ProcessingPV OperationsRegulatory ComplianceQuality Standards5+ PV Databases
Leadership & PM
Team Leadership (up to 50)Project DeliveryStakeholder ManagementRisk MitigationResource Allocation
Data & Process
Performance AnalyticsDashboard DesignProcess OptimizationAutomationRoot Cause Analysis
Certifications
Project Management EssentialsAI Tools WorkshopPDCTMRoot Cause Analysis
Highlights
Selected projects & contributions.
Scaling Multi-Project PV Operations
Led up to five concurrent ICSR case processing projects with teams of up to 50, consistently meeting SLAs across timelines, quality, and productivity.
LeadershipOperationsSLA
Operational Frameworks for Safety Ops
Built scalable, transparent frameworks aligning day-to-day PV delivery with regulatory expectations and business priorities.
ProcessGovernance
[Placeholder] Case Study / Publication
Add a specific project write-up, whitepaper, or industry talk here so recruiters can dive deeper into a signature achievement.
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