Browse Definitions :
Definition

pharmacovigilance

Pharmacovigilance is the use of scientific methods to identify, track, record and analyze over time the effects of various pharmaceutical goods in order to ensure drug quality and safety. Pharmacovigilance pertains to almost every part of the drug lifecycle, ranging from preclinical development to post-market surveillance. Pharmacovigilance programs often deal with counterfeit drugs because counterfeiting can hamper the performance of otherwise safe pharmaceuticals.

The aim of pharmacovigilance is to find possible risks and adverse effects, analyze medical information to track effects, and inform health-care professionals and the public of this information. Other goals of pharmacovigilance include the early detection of safety problems that are not revealed during clinical trials, the identification and quantification of risks, and the improvement of patient care as well as safety in relation to the use of pharmaceutical drugs.

A key aspect of pharmacovigilance is identifying which side effects are worth the risk to patients, versus how effective they are at treating a disease. For instance, chemotherapy’s serious side effects – weighed against life-threatening cancer – may be considered acceptable, given the potential to cure a patient. Yet if a drug for curing a headache caused similar side effects, the risk to the patient would outweigh the benefits.

Pharmacovigilance is a crucial function within life science companies. Businesses that develop, manufacture and commercialize drugs must adhere to strict regulations, many of which focus on patient safety and well-being – and are at the heart of pharmacovigilance.

A strong pharmacovigilance strategy requires expertise in medicine, regulatory requirements and technology. It involves strong processes, case study report capture and processing, literature screening, signal detection and assessment, risk management, periodic safety writing, regulatory expedited reporting and safety databases. 

Organizations that have pharmacovigilance programs designed to monitor drug use statistics; identify risks and adverse effects; and educate the medical, scientific and lay communities regarding drug safety include the World Health Organization, the International Society of Pharmacovigilance, the U.S. Food and Drug Administration (FDA), and the U.K.’s Medicines & Healthcare Products Regulatory Agency.

This was last updated in November 2017
SearchCompliance
  • compliance risk

    Compliance risk is an organization's potential exposure to legal penalties, financial forfeiture and material loss, resulting ...

  • information governance

    Information governance is a holistic approach to managing corporate information by implementing processes, roles, controls and ...

  • enterprise document management (EDM)

    Enterprise document management (EDM) is a strategy for overseeing an organization's paper and electronic documents so they can be...

SearchSecurity
  • IPsec (Internet Protocol Security)

    IPsec (Internet Protocol Security) is a suite of protocols and algorithms for securing data transmitted over the internet or any ...

  • principle of least privilege (POLP)

    The principle of least privilege (POLP) is a concept in computer security that limits users' access rights to only what are ...

  • biometric authentication

    Biometric authentication is a security process that relies on the unique biological characteristics of individuals to verify they...

SearchHealthIT
SearchDisasterRecovery
  • risk mitigation

    Risk mitigation is a strategy to prepare for and lessen the effects of threats faced by a business.

  • call tree

    A call tree is a layered hierarchical communication model that is used to notify specific individuals of an event and coordinate ...

  • Disaster Recovery as a Service (DRaaS)

    Disaster recovery as a service (DRaaS) is the replication and hosting of physical or virtual servers by a third party to provide ...

SearchStorage
  • cloud storage

    Cloud storage is a service model in which data is transmitted and stored on remote storage systems, where it is maintained, ...

  • cloud testing

    Cloud testing is the process of using the cloud computing resources of a third-party service provider to test software ...

  • storage virtualization

    Storage virtualization is the pooling of physical storage from multiple storage devices into what appears to be a single storage ...

Close