Helly Patel

Pharmacovigilance Specialist @Shoppers Drug Mart

Mississauga, ON, CA

Monitor, collect, and evaluate adverse drug reactions (ADRs) and safety information in compliance with Health Canada pharmacovigilance regulations- Perform case processing, including intake, data entry, medical coding (e.g, MedDRA), and narrative writing for Individual Case Safety Reports (ICSRs)- Ensure timely and accurate reporting of adverse events to regulatory authorities and pharmaceutical manufacturers- Conduct signal detection and safety trend analysis to identify potential drug safety concerns- Collaborate with internal teams (pharmacy, patient support programs, and medical affairs) to ensure patient safety and regulatory compliance- Maintain and update pharmacovigilance databases and ensure data integrity and audit readinessSupport risk management plans (RMPs) and periodic safety update reports (PSURs/PBRERs)Participate in quality assurance activities, including SOP development, compliance checks, and internal audits- Provide training and guidance to staff on adverse event reporting procedures and pharmacovigilance practicesAssist in inspections and audits by regulatory authorities and ensure adherence to Good Pharmacovigilance Practices (GVP)