Open to opportunities

Prakriti Verma

@prakkritiverma

Message

AI-forward pharmacovigilance leader driving automation and regulatory-compliant safety operations.

India

Message

What I'm looking for

I seek a role combining pharmacovigilance, AI-driven process improvement, and connected-device project management where I can lead cross-functional teams, ensure regulatory compliance, and drive operational efficiency.

I am an AI-forward pharmacovigilance leader and registered pharmacist with a decade of experience delivering global safety operations, inspection readiness, and cross-functional team leadership. I've led multi-regional drug-device combination studies and maintained 99%+ compliance across high-volume ICSR programs.

My work centers on process optimization and AI integration: I implemented AI language tools to improve ICSR listedness assessments across 50+ labels, automated workflows that produced a 60% efficiency gain, and developed standardized SOPs and templates that saved 200+ hours/month. I also drove measurable quality improvements — reducing QC errors by 35% and repeat deviations by 25% — while maintaining inspection readiness for FDA/EMA audits.

I mentor and build capability in teams, having trained 150+ scientists in MedDRA coding and PV processes, led hiring and project reviews, and supported end-to-end project delivery. I am seeking to leverage my pharmacovigilance, AI, and project management skills into connected devices project management roles that ensure robust device data integration and regulatory compliance.

Experience

Work history, roles, and key accomplishments

Associate Manager

Parexel International Services India Private Limited

Feb 2022 - Jan 2023 (11 months)

Led generative AI integration and end-to-end project management for connected drug-device studies, improving ICSR accuracy and compliance while delivering multi-regional projects on time and within scope.

Pharmacovigilance Integration ICSR Management Argus Regulatory Compliance Project Management

Pharmacovigilance Specialist

Parexel International Services India Private Limited

Apr 2015 - Feb 2022 (6 years 10 months)

Streamlined case processing and QC for 500+ SAEs/year, implemented templates and checklists that reduced turnaround time and data entry errors, and maintained 100% on-time submissions during audits.

MedDRA Signal Detection Regulatory Submissions

Pharmacovigilance Analyst

Quantum Solutions India

Jun 2012 - Mar 2015 (2 years 9 months)

Managed end-to-end processing of 5,000+ annual ICSRs across multiple streams, reduced triage-to-submission time by 40%, and achieved zero findings in consecutive database audits.

ICSR Registration Data Validation Triage Case Summaries