As argued by Constant Allabi (2014), independent and systematic examination of the activities determine as audit. Pharmacovigilance audit is one of the most effective ways of analysing activities within the workplace. According to Carson and Dent (2007), Pharmavigilance system audits helps in ensuring the compliance with the procedure of company locally as well as globally. Apart from that, Pharmavigilance audit identifies the appropriate activities and improve the quality of the organisation. The pharmacovigilance audit has three different types activities such as company affiliates like local company, marketing company, country office; global pharmacovigilance system like signal detection, safety case processing literature search and marketing partners. Description of various steps that involved in conducting a pharmacovigilance audit Step 1: Administrative and legal aspects In order to conduct the pharmacovigilance system audit, need to identify the Qualified Person Responsible for Pharmacovigilance (QPPV). Apart from that, for conducting the pharmacovigilance audit need to make documentation of all responsible parties for drug safety activities (Walker et al. 2013). Collection of information and reporting of SAEs in the clinical trials is also a major aspect of conducting pharmacovigilance audit. Step 2: Organisational Structure The structure of pharmacovigilance audit has to be maintaining Standard Operating Procedures (SOP) and Quality System. Following is structure that needs to maintain – (Source: Created By Author) Step 3: Facilities and Computer System For developing the phramacovigilance audit, computer system is one of the most useful methods. Use of hardware and related software along with validation in much required for developing the phramacovigilance audit system (Jolley and Lechner, 2007). Legacy system and data migration facility is also another aspect of conducting pharmacovigilance (Singhal, 2014). Filling facilities and archiving facilities is also important part of building phramacovigilance audit. Step 4: Safety Information through clinical investigation Through qualification and training, need to involve the responsible person or staff that relates to the clinical trials. Apart from that, making documentation of medical review of the SAE also required for conducting successful Pharmacovigilance audit. Moreover, Carson et al. (2007) argued that report of production and submission is also key aspect of Pharmacovigilance audit. In clinical trial, reconciliation of information as well as the database of the Pharmacovigilance is also another aspect of Pharmacovigilance audit system (Walker et al. 2013). Step 5: Safety Information from other departments For conducting the Pharmacovigilance system audit, organisation or the respected team member has to collect information from the marketing department as well as the regulatory affairs department. Moreover, Jolley and Lechner (2007) argued that, handling of medical information as well as the information that legal must to be considers for the development of Pharmacovigilance audit. According to Maheshwari (2012), detection of quality service and complaints has to be examined properly in terms of creating the Pharmacovigilance audit. After examined the information, need to reconcile the data and organized it according to the requirements. Step 6: Documentation and Data Review Following are the process as well as strategies that need to be inspect for conducting the successful Pharmacovigilance audit – Causality assessment Generate quality of information in terms of making case summaries Adequacy of information regarding data collection and information Completeness and Quality of medical review Determination of seriousness Determination of expectedness (Ema.europa.eu, 2015) Step 7: Record inspection observation This is the most valuable step in conducting Pharmacovigilance audit. In order to conduct the Pharmacovigilance audit, the entire observation report has to be documented. Apart from that, need to make the record of appropriate copies that contains as well as illustrates the non-compliance. Step 8: Monitoring of effectiveness and performance In accordance to Singhal (2014), objective has to be set for quality assurance and regular monitoring is required for conducting the Pharmacovigilance audit. It is also one of the most valuable parts of management reviews. For developing the Pharmacovigilance audit, need to take action of arising reviews that are traced and logged. Conclusion This report demonstrated the several ways that required for conducting the Pharmacovigilance audit. In this study, analyst represents the many components that required for developing the Pharmacovigilance audit. It has been analyzed that each components are important and their contribution is required for the Pharmacovigilance audit. The program of Pharmacovigilance audit helps in minimizing the company. Apart from that, Pharmacovigilance audit also help in identifying the future opportunities for improvement the organisational process.