Pharmacovigilance Services in Canada

Whether you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Canada, access to pharmacovigilance services in Canada is vital to ensure drug safety and regulatory compliance. From adverse drug reaction reporting to adherence to Health Canada pharmacovigilance regulations, the right local PV partner shapes everything, from signal detection and risk management planning to safety reporting and successful market maintenance.

Expert Pharmacovigilance Services for the Canada Market

The Canada Vigilance Program, managed by Health Canada’s Marketed Health Products Directorate (MHPD), is the national pharmacovigilance system in Canada. It collects and assesses suspected adverse reaction (ADR) reports for drugs, biologics, natural health products, radiopharmaceuticals, and medical devices. ADR reports are submitted voluntarily by patients/consumers, healthcare professionals, manufacturers, and distributors directly to Health Canada or via Marketing Authorization Holders. With seven regional offices acting as local points of contact, the Canada Vigilance Program ensures efficient ADR collection and management across the country. All submissions enter the Canada Vigilance Online Database for analysis and public access.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs and SUSARs
  • Processing through E2B(R3)-compliant databases with WHO Drug Dictionary and MedDRA integration
  • Quality checks and medical reviews
  • Submission aligned with agency timelines
  • Maintaining tracking sheets and reconciliation with clients
• + Risk Management Plan (RMP)
  • Drafting, reviewing, and maintaining RMPs and REMS
  • Custom procedures to classify safety risks and implement tailored strategies
  • Assessment and reporting of risks and missing information
  • Implementation of Post-Authorization Safety Studies (PASS), including academic materials, observational studies, and follow-up questionnaires
  • Communicate risks via Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)
• + Aggregate Reports
  • Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Periodic Safety Update Reports (PSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Detection of new safety signals from ICSRs, literature, and agency monitoring
  • In-house tools for signal detection, tracking, and analysis
  • Review of signals per ICSR, aggregate reports, and recommendations (e.g., PRAC-like bodies)
  • Label update analysis and risk minimization recommendations
  • Preparation of Signal Management Tracker and Annual Signal Reports
• + Specialized PV Support Services in Canada
  • Review of PSMF, Safety Data Exchange Agreements (SDEAs), SOPs, and partner contracts
  • Review/sign-off of Aggregate Reports, Signal Reports, and RMPs
  • Retainer services providing dedicated pharmacovigilance expertise and acting as the local PV contact in Canada
  • Regular reconciliation, medical review of signals, quarterly surveillance meetings
  • Monthly compliance communication reports
• + PV Quality Management System Oversight
  • Compliance audits against PV guidelines, Health Canada regulations, SDEAs, SOPs, and work instructions
  • Design and execution of audit plans and mock inspections to prepare for Health Canada inspections
  • Gap assessments of PV personnel at site
  • Organizational training on safety audits and inspections