Pharmacovigilance

Pharmacovigilance is a great career option for life science and pharmacy graduates. It is a scientific discipline that is primarily concerned with reporting and analysing of drug side effects. It is primarily due to the work of Pharmacovigilance professionals that the drugs in the market that we consume are mostly safe and those that are found harmful are taken off the market. Pharmacovigilance professionals continuously monitor the safety of the drugs in clinical trials as well as the drugs already being sold in the market. After a drug side effect is reported, the Pharmacovigilance professionals enter the event in relevant databases, follow up with the case to gather more information and forward these reports to regulatory authorities and other applicable bodies. The Pharmacovigilance professionals identify signals in data that may point towards a potential side effect and probe the case further.

• Introduction
• Pharmacovigilance System And Its Quality Systems
• Pharmacovigilance System Master File (PSMF)
• Pharmacovigilance Inspections
• Management and Reporting of Adverse Reactions
• Periodic Safety Update Report
• Post-Authorisation Safety Studies
• Risk management activities and the drug development programme
• Stakeholder perspectives on construction and execution of risk management plans
• Development of best practice techniques
• Management of drug safety after reclassification