Pharmacovigilance
Maximizing safety. Minimizing risk.
Good Pharmacovigilance Practice (GVP) is the foundation of patient safety and public confidence in medicines. Whether you are delivering pharmaceuticals, medical devices or natural health products to patients, we offer complete solutions that maximize patient safety and minimize manufacturers’ risks.
Demonstrating product safety and quality monitoring
Our integrated, comprehensive and cost-effective Pharmacovigilance and Medical Information services help ensure compliance with continually evolving regulatory requirements. Our multilingual team of Pharmacovigilance and Medical Information professionals is experienced in Canadian, FDA, and EU pharmacovigilance regulations and reporting standards. This ensures the highest quality of safety data collection and processing to facilitate regulatory compliance across global markets.
Customized reporting of safety information
Our multi-disciplinary team of drug safety specialists provides a range of critical solutions that can be customized to meet your requirements, including support for:
- Standardized compliance monitoring process
- Validated databases with E2B connectivity and gateway submissions
- Reporting of Individual Case Safety Reports (ICSRs) related to Adverse Events (AEs)/Safety Information
- Product Quality Complaints (PQCs)
- MedDRA coding
- Source Data Quality Checks
- Reconciliation
Our responsibility to your business
Our drug safety specialists are trained to ensure compliance with Pharmacovigilance requirements at the intake level, through source data verification and the monitoring of Key Performance Indicators (KPIs). Our expert team stays ahead of your Pharmacovigilance requirements by maintaining the documentation and tools you need, including:
Health Canada database reconciliation and monitoring
Risk Management Plans (RMPs)
Risk Evaluation and Mitigation Strategies (REMS)
Pharmacovigilance Systems Master File (PSMF) repository
Audit and Inspection support
Assistance with procedures or documentation writing
Centralized, multilingual call centre
Adverse Events line-listing
Solicited follow-up requests
Aggregate/periodic safety reports (PSURs/PBRERs)
Global and local literature searches and reviews
Medical Information support
Working alongside you, our Medical Information (MI) specialists develop programs customized to meet your service needs. Beginning with intake, triage, assessment, and submission of medical/product information, we further support you by generating standardized responses, letters and FAQ sheets for efficient management of MI requests. Our MI specialists provide support in both English and French, with translation services for 180 additional languages, if needed.
