Jay Bhatt
@jaybhatt
Pharmacovigilance leader with 10 years' experience in drug safety and PV management.
What I'm looking for
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
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.
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.
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.
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
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
Bachelor of Pharmacy, Pharmacy
2008 - 2011
Completed a Bachelor of Pharmacy program and ranked among the top 10% of the batch.
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
Availability
Location
Authorized to work in
Job categories
Skills
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