Sonia Bhatt

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.

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.

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.

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.

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.

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

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

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