Pharmacovigilance Agreements Optimization

The Pharmacovigilance Agreements Optimization (PVAO) Initiative seeks to produce a suite of customizable solutions for organizations, whether new or experienced in the pharmacovigilance agreement (PVA) process, which could be used to inform and/or streamline their end-to-end PVA process.


The volume and complexity of PVAs continually increase year over year. Inefficiencies in negotiating and complying with PVAs wastes resources and contributes to non-value-added work due to: ​

  • Ambiguous contractual terms and definitions can lead to non-compliance and increase the potential for audit and inspection findings.
  • Lengthy negotiation periods & contractual maintenance discussions may lead to delays and potentially strained business relationships.
  • Lack of awareness and data around operational timelines often used in PVAs can lead to negotiation inefficiencies.
  • Complexity of PVA structures and content leads to challenges in review & negotiating terms.

​The Pharmacovigilance Agreements Optimization Initiative focuses on addressing foundational elements related to PVAs, such as:

  • The development, implementation, and maintenance of PVAs.
  • Considerations for the table of contents and glossary.
  • Benchmarking data of exchange timelines found in PVAs.

Importantly, this initiative does not seek to produce a standard industry PVA template nor provide recommendations pertaining to data exchange. Rather, this initiative seeks to produce a suite of customizable solutions for organizations, which could be used to support their end-to-end PVA process.


  • Reduce drafting and negotiation time, thereby potentially improving the timeliness and reducing the risk of delays to key milestones, such as clinical trial start, product launch, and asset transfer.
  • Increase awareness of considerations that may impact PVA development.
  • Serve as a resource for those involved in the end-to-end PVA process, including individuals newly engaging in PVA activities, or where a dedicated PV licensing function does not exist.
  • Support improvement of accuracy and completeness of PVA, which may:
    • Better support compliance to PVA and applicable regulations.
    • Foster more comprehensive data exchange for PV activities, such as signaling and surveillance.
  • Better support patient safety.

Available Solutions

The following solutions are now available:

  • Process Map: An interactive tool that illustrates the end-to-end PVA lifecycle and key considerations throughout the development of PVAs.
  • Glossary: Listing of definitions and synonyms often incorporated into PVAs. The Glossary was updated in July 2022 to Version 2.0.
  • Table of Contents: A framework of headings and points to consider for potential incorporation into PVAs, including regulatory citations.
  • Timelines Benchmarking: Aggregated benchmarking data of exchange timelines in member companies’ PVAs.
  • Audit Process Efficiency: Marketing Partner audit scheduling, scoping, risk prioritization, conduct, response, and follow-up considerations.

Related Initiatives

Value of Safety Information Data Sources

The Value of Safety Information Data Sources Initiative will seek to identify sources of safety information for single high value valid cases and develop a proposed method for aggregate reporting of lower value cases.