Open to opportunities

Sonia Bhatt

@soniabhatt

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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

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.

Pharmacovigilance Safety Reporting Regulatory Submissions Adverse Events CAPA

Operational Pharmacy Supervisor

Shoppers Drug Mart

Apr 2023 - Mar 2024 (11 months)

Managed daily pharmacy operations and regulatory compliance, mentored staff to improve service delivery and reduced operational errors while implementing cost-saving measures and conducting internal audits.

Pharmacy Operations Regulatory Compliance Staff Training Auditing Inventory Management performance reporting Cost Control

Alternate Qualified Person In Charge

Kohl & Frisch

Mar 2021 - Apr 2023 (2 years 1 month)

Oversaw GMP-compliant handling of narcotics and controlled substances, supervised inventory control and shipping logistics, and maintained 100% compliance in monthly narcotics audits per Health Canada.

Controlled Substances Inventory Control Auditing Compliance Management Logistics

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.

Clinical Research GCP)SOP Development QA Regulatory Compliance GCP

Assistant Professor

Shree Naranjibhai Lalbhai Patel College of Pharmacy

Jul 2013 - Jan 2021 (7 years 6 months)

Delivered lectures in pharmacology and supervised research and preclinical toxicology studies under GLP/OECD, mentored 200+ students and published peer-reviewed papers to advance academic research and training.

Academic & Research GLP OECD Toxicology Studies Curriculum Development Mentorship Publishing