Pharmacovigilance

DSA offers a range of pharmacovigilance services to DSA Clients.  Each client relationship is different, and services offered can range from DSA holding all of the Canadian PV responsibility to a shared responsibility with the client or other parties.  Our services include:

• Writing SOPs to govern the Canadian pharmacovigilance program.
• Establishing safety profiles 
• Preparing agreements such as Safety Data Exchange Agreements for Canada or Pharmacovigilance Agreements
• Reporting domestic serious unexpected and unexpected adverse drug reactions (ADR) to Health Canada
• Reporting foreign serious unexpected adverse drug reactions (ADR) to Health Canada
• Reporting Lack of Efficacy for new drugs
• Monitoring and Reporting Foreign Actions to comply with C.01.050
• Monitoring Regulatory Authorities Sources
• Monitoring Scientific Literature
• Preparing Annual Summary Reports or Periodic Safety Update Reports (PSUR)
• Preparing Annual Periodic Benefit-Risk Evaluation Report (PBRER)
• Preparing Issue Related Summary Reports
• Conducting Signal Detection Reviews
• Conducting PV Self-Inspections or PV Audits of other service providers.
• Qualified Healthcare Practitioners on staff to meet Canadian requirements