Arun Bhat

Senior Drug Safety Specialist

Role: Senior Drug Safety Specialist at Fidelity Health Services
Location: Bengaluru, IN
LinkedIn followers: 500 followers

About Arun Bhat

Experienced Reviewer with a demonstrated history of working in the hospital & health care industry. Skilled in Electronic Data Capture (EDC), Oncology, Clinical Data Management, Psoriatic Arthritis, and Good Clinical Practice (GCP), submission of expedited cases (SERIOUS UNEXPECTED) to USFDA, EMA, TGA, PvPI, RUSSIA. Medical devices cases (processing and quality review of all serious and non- seriius cases including literature, clunical trial, E2B, Spontaneous etc.). Strong quality assurance professional with a Master\'s Degree focused in Pharmacology from Nagpur University.

Experience

Senior Drug Safety Specialist
Fidelity Health Services
Mar 2018 — Present · Mumbai, IN

Education

Nagpur University
Master's Degree, Pharmacology, Grade I
2011 — 2013

Contact information

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•••••@fidelityhs.com
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Current company

Fidelity Health Services

Pharmaceutical Manufacturing · 79 employees · Founded 2016 · Brampton, Ontario, Canada

Fidelity Health Services is a global pharmacovigilance and drug safety partner built for life sciences companies that value precision, accountability, and long-term trust. For over a decade, we have supported pharmaceutical, biotech, and healthcare organizations with technology-enabled, inspection-ready safety operations across the full product lifecycle. Our teams operate seamlessly across the United States, Canada, the United Kingdom, and India, delivering consistent quality while aligning with global regulatory expectations. We bring deep experience with global multinational innovators, large generics, biotechs, and CROs, backed by a decade of managing high-value PV operations for complex global portfolios. Our Expertise: • Extensive experience managing large case volumes over the past decade across ICSRs, literature surveillance, and signal management • PV system implementations, database migrations, upgrades & validations (Argus, ArisG, Veeva) • Inspection-ready operations with FDA, EMA & MHRA clearance, zero critical findings in the last five years • Technology-enabled processes that streamline workflows, enhance accuracy, reduce manual effort & accelerate regulatory timelines • Flexible engagement models: FTE, FSP, per-case/project, or full end-to-end outsourcing • Broad therapeutic depth across biologics, small molecules, vaccines & advanced therapies • Proven experience in PV system optimization, automation support & custom technology solutions Global Reach & Impact: Serving 30+ multinational clients with a hybrid onshore–offshore model that ensures 24×7 continuity, seamless client collaboration, and cost-efficient delivery. Our Vision To redefine global pharmacovigilance through technology-enabled, efficient, and compliant drug safety solutions, empowering life sciences organizations to deliver safer therapies worldwide. For partnerships, collaborations, or to submit an RFP, we welcome you to connect with us.

fidelityhs.com

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