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@soniabhatt
Pharmacologist and clinical research leader driving regulatory-compliant operations.
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.
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Work history, roles, and key accomplishments
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.
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.
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.
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.
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.
Degrees, certifications, and relevant coursework
Post-Graduate Diploma, Clinical Research
2022 - 2023
Completed a Post-Graduate Diploma in Clinical Research focusing on clinical trial processes and regulatory compliance.
Master of Pharmacy, Pharmacology
2011 - 2013
Completed a Master of Pharmacy (M.Pharm) in Pharmacology with coursework and research in pharmacology and toxicology.
Bachelor of Pharmacy, Pharmacy
2007 - 2011
Completed a Bachelor of Pharmacy (B.Pharm) with foundational training in pharmaceutical sciences and pharmacy practice.
Software and tools used professionally
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