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JB
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Jay Bhatt

@jaybhatt

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

India
Message

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

TS
Current

Team Leader - Drug Safety

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.

CS

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.

KH

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.

Education

Degrees, certifications, and relevant coursework

IR

Imperial Institute of Clinical Research

Advanced Post Graduate Diploma in Clinical Research, Clinical Research

Completed an Advanced Post Graduate Diploma in Clinical Research in November 2012.

Rajiv Gandhi University of Health Sciences logoRS

Rajiv Gandhi University of Health Sciences

Bachelor of Pharmacy, Pharmacy

2008 - 2011

Completed a Bachelor of Pharmacy program and ranked among the top 10% of the batch.

DU

Diploma in Pharmacy (institution unspecified)

Diploma in Pharmacy, Pharmacy

2006 - 2008

Completed a Diploma in Pharmacy and ranked among the top 10% of the batch.

Tech stack

Software and tools used professionally

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