Pharmacovigilance (PV)
We operate Canadian PV systems end to end on your behalf. We provide case intake and processing, medical review, Canada Vigilance submissions and reconciliation, aggregate reporting, audits and inspection-readiness, signal and literature surveillance, RMP adaptation, and safety-database operations; delivered by qualified PV professionals.
Expertise
Who we Support
DIN holders across pharmaceuticals, biologics and over the counter (OTCs); innovators and generics, natural health products (NHPs), and medical devices. We support teams that need Canadian PV coverage with bilingual (English & French) delivery.
Whether you're managing routine safety monitoring or addressing complex regulatory needs, our services adapt to your specific requirements.
OUR SOLUTIONS
Core Services
Zenith crafts simple, compliant paths for your drugs and biologics starting with gap assessment, ending with compliance rating.
- Bilingual intake, triage, medical review and processing of individual case safety reports (ICSRs)
- Canada Vigilance & FDA submissions and reconciliation at defined cadence
- Follow-up management and source data checks
- KPIs and quality checks with corrective actions where needed
- PBRER/PSUR and Canadian aggregate summaries on schedule
- Signal detection, assessment summaries, trend charts and management actions
- Cross-links to RMP updates where applicable
- Set-up the scientific literature screening approach with relevant journal list and appropriate search string based on product category
- Periodic bilingual scientific literature searches and documentation of results
- Optional dashboards for review meetings (validated for intended use)
- Automated screening of Regulatory Authority websites for applicable product categories
- Integrated machine-translation capability to translate information from foreign sites
- Validated key-words for accurate search in alignment with Health Canada requirements
- Assessment of identified signals with the approved Canadian label for reporting
- Submission of notifiable actions via applicable channels (Online & ESG)
- Adaptation of global RMPs for the Canadian context
- Development of Canadian RMPs and CSO-tRMPs, updates and routine monitoring
- Educational materials and effectiveness checks with evidence kept on file
- Internal PV self-inspections and vendor audits with CAPA monitoring
- Evidence check, interview notes and rehearsal sessions for Health Canada GVP inspections
- CAPA implementation and audit closure handling
- Validated safety-database direct set-up or managed through Zenith
- Change control, user access reviews and audit trail checks
- Secure, bilingual outputs and record exports for regulatory inspections
- Data protection and privacy check applicable to PV records
- PV system master files, SOPs, work instructions and forms
- Role-based training plans and attendance records
- Partner oversight and PV agreements (PVA) compliance Â
Book A Discovery Call
Book a discovery call with a Zenith PV senior partner today to discuss your needs, uncover gaps, and kickstart your compliance journey.
How we work
Our pharmacovigilance services integrate seamlessly with regulatory affairs, quality assurance, and medical information, delivering end-to-end safety monitoring from case processing to signal detection. Rooted in our values of trust and ownership, this approach provides direct senior access and transparent practices that build lasting client partnerships.
Clear scope
Products in scope of GVP Compliance, frequency of screening, report types and timelines.
Defined outputs
Submission logs, reconciliation records, aggregate calendars, audit evidence and KPIs.
Audit Trail
Version-controlled documents, record maintenance, response logs and database validation bundles.
Canadian Compliance
Performed by a qualified Canadian team with English and French capabilities.
Typical starting points
Gap Review
Quick PV gap review ahead of a Health Canada GVP inspection
Regulatory Agreements
Set-up PV agreements (PVA) and Safety Data Exchange Agreement (SDEA)
Process Set-up
Define the process covering global and local PV requirements
KPIs and Reporting
Identify relevant performance metrics and reporting templates
English 
French