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Sonia Bhatt

@soniabhatt

Pharmacologist and clinical research leader driving regulatory-compliant operations.

India
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What I'm looking for

I seek roles in clinical research or pharma operations that prioritize regulatory excellence, collaborative teams, and opportunities to lead QA/process improvements.

I am a pharmacologist with 12+ years in clinical research, pharmacovigilance, pharmaceutical operations, and academia, known for driving regulatory compliance (GCP, GMP, GLP, OECD, ICH) and improving operational efficiency. I have led teams, implemented process improvements, and bridged academic research with industry practice to deliver reliable preclinical and clinical study outcomes.

My achievements include improving pharmacy operations efficiency by 20%, reducing compliance errors by 15%, ensuring 100% compliance in controlled substances management, mentoring 200+ students, and supporting GCP-compliant clinical trials with Health Canada and FDA interactions. I excel at SOP development, quality assurance, data management, and translating scientific rigor into operational excellence.

Experience

Work history, roles, and key accomplishments

PL

Pharmacovigilance Associate

PSPSync Ltd.

Mar 2024 - Aug 2025 (1 year 5 months)

Managed collection, validation, and analysis of adverse event reports and product complaints for regulatory submissions to Health Canada, FDA and EMEA; performed quality reviews, RCA and implemented CAPA to improve safety reporting and data integrity.

BI

Clinical Research Coordinator

BioPharma Services Inc

Nov 2022 - Jan 2023 (2 months)

Prepared study documentation ensuring GCP compliance, supported clinical procedures and QC/QA audits, and assisted in SOP development aligned with FDA, Health Canada and ICH guidelines.

Education

Degrees, certifications, and relevant coursework

EC

Evergreen College

Post-Graduate Diploma, Clinical Research

2022 - 2023

Completed a Post-Graduate Diploma in Clinical Research focusing on clinical trial processes and regulatory compliance.

Gujarat Technological University logoGU

Gujarat Technological University

Master of Pharmacy, Pharmacology

2011 - 2013

Completed a Master of Pharmacy (M.Pharm) in Pharmacology with coursework and research in pharmacology and toxicology.

Veer Narmad South Gujarat University logoVU

Veer Narmad South Gujarat University

Bachelor of Pharmacy, Pharmacy

2007 - 2011

Completed a Bachelor of Pharmacy (B.Pharm) with foundational training in pharmaceutical sciences and pharmacy practice.

Tech stack

Software and tools used professionally

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Sonia Bhatt - Pharmacovigilance Associate - PSPSync Ltd. | Himalayas