Open to opportunities

Jay Bhatt

@jaybhatt

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Pharmacovigilance leader with 10 years' experience in drug safety and PV management.

India

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What I'm looking for

I seek a pharmacovigilance leadership role where I can drive drug-safety operations, mentor teams, improve processes, ensure regulatory compliance, and contribute to audit readiness in a collaborative, quality-focused organization.

I am a Pharmacy graduate with ten years of focused experience in Pharmacovigilance and Clinical Research, consistently delivering high-quality drug safety operations and regulatory-compliant case management.

I have led cross-functional and distributed teams (including up to 75 direct reports) to meet SLAs, drive process improvements, and manage stakeholder relationships across global clients and regulatory bodies.

I bring hands-on expertise in case processing, ICSR management, narrative writing, GVP/ICH-FDA-EMA compliance, and safety databases (Argus, ArisG, LifeSphere), and I am proactive about coaching teams and improving quality and audit readiness.

Experience

Work history, roles, and key accomplishments

Current

Team Leader - Drug Safety

Current

Tata Consultancy Services

Sep 2023 - Present (2 years 1 month)

Lead a pharmacovigilance team delivering drug safety services to clients, ensuring high-quality case processing within timelines and coordinating with stakeholders to resolve issues. Conduct performance appraisals, drive cross-functional collaboration, and improve team productivity and compliance.

Pharmacovigilance Case Processing Stakeholder Management Team Leadership Quality Assurance GVP省令 SLA Management

Associate Manager - Pharmacovigilance

Covance Scientific Services & Solutions

Dec 2019 - Feb 2021 (1 year 2 months)

Managed a distributed team of ~75 across India and Philippines, led process improvement and training initiatives, and coordinated onshore/offshore stakeholder communications to maintain quality and operational metrics. Conducted performance reviews and managed escalation handling.

Team Management Process Improvement Training Development Stakeholder Management Performance Management Pharmacovigilance

Team Leader - Pharmacovigilance

Cognizant Technology Solutions

Dec 2012 - Dec 2019 (7 years)

Led case prioritization and ICSR management to meet SLAs, investigated regulatory delays and client escalations, and performed capacity and performance planning to ensure smooth engagement operations. Served as SME for spontaneous and PMS case processing.

ICSR Management Case Processing Root Cause Analysis Capacity Planning MedDRA GCP)GCP

Clinical Research Coordinator Trainee

Kokilaben Dhirubhai Ambani Hospital

Jul 2012 - Oct 2012 (3 months)

Supported clinical research coordination activities during a three-month trainee assignment, assisting with study procedures and documentation to ensure trial conduct and regulatory compliance.

Regulatory Compliance GCP)Trial Support GCP