Article
Harmonizing and safeguarding global and local pharmacovigilance processes
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José Miguel Rivas Romero
Why pharma companies need a well-planned and broad strategy to meet local and global PV requirements while managing regulatory and cost demands
Pharmacovigilance requirements place an enormous burden on global pharmaceutical companies, which must manage evolving and diverse local regulations while seeking to harmonize processes.
Stringent monitoring obligations are complicated by a scarcity of experienced local personnel. These obstacles are further exacerbated for companies with novel products, such as cell and gene therapies and monoclonal antibodies, that face heightened scrutiny, adding to resource pressures. To meet these demands while reducing costs, global pharmaceutical companies have long sought to centralize and standardize routine activities to partners with lower cost centers – such as India, Eastern Europe, and Latin America – and work with those same partners that have a local network to manage in-country activities where required and ensure a clear line of communication with the local health authorities.
While that model has been important for cost and efficiency gains, companies increasingly want assurance that there are safeguards in place to ensure the quality of their PV services.
Stringent monitoring obligations are complicated by a scarcity of experienced local personnel. These obstacles are further exacerbated for companies with novel products, such as cell and gene therapies and monoclonal antibodies, that face heightened scrutiny, adding to resource pressures. To meet these demands while reducing costs, global pharmaceutical companies have long sought to centralize and standardize routine activities to partners with lower cost centers – such as India, Eastern Europe, and Latin America – and work with those same partners that have a local network to manage in-country activities where required and ensure a clear line of communication with the local health authorities.
While that model has been important for cost and efficiency gains, companies increasingly want assurance that there are safeguards in place to ensure the quality of their PV services.
They want to know that there is proper oversight of all PV activities, that local safety experts are fully qualified and trained, and that there is a reliable quality management system to rapidly assess, identify, and act on any issues. Cost savings matter, but not at the expense of staying compliant and ensuring patient safety comes first.
Key pillars for mitigating PV risk
Companies need a well-planned and broad strategy to meet local and global PV requirements while managing regulatory and cost demands. When working with PV outsourcing partners, they need to know that the issues that create the greatest risk and burden – at a global and local level – are being managed holistically. This is best achieved through four core pillars: people, harmonization, digitalization, and communication.
Having the right people to lead PV from a global and local perspective is key to meeting regulatory obligations and tackling efficiency barriers. This people-first approach starts with a centralized governance model, supported by hub and in-country coordinators who are accountable for overseeing operations across the different countries and for reviewing key performance indicators, with work being centralized through the hubs.
A technical lead is also needed in this centralized model to ensure accountability for delivery within the project, orchestrate all the operational activities across the hubs and local affiliates, work in close coordination with the hub and in-country coordinators, and act as single point of contact for the project.
With the move to shift many PV activities to a central hub, concerns have been raised about how this impacts local affiliate staff. However, for many, this can be an opportunity for these individuals to grow professionally and move into central functions to support the global PV strategy. This requires a change-management approach to local resources and a commitment to helping talented staff embrace change and work in different areas.
A technical lead is also needed in this centralized model to ensure accountability for delivery within the project, orchestrate all the operational activities across the hubs and local affiliates, work in close coordination with the hub and in-country coordinators, and act as single point of contact for the project.
With the move to shift many PV activities to a central hub, concerns have been raised about how this impacts local affiliate staff. However, for many, this can be an opportunity for these individuals to grow professionally and move into central functions to support the global PV strategy. This requires a change-management approach to local resources and a commitment to helping talented staff embrace change and work in different areas.
A challenge many companies have is that their local PV activities are managed without clear central oversight, resulting in fragmented visibility across the regions. This puts companies at greater compliance and audit risk, while also increasing overall costs.
This is avoidable since many PV activities can be centralized and processes standardized to achieve consistent reporting across countries and improve efficiency. Optimizing global, regional, and local pharmacovigilance processes not only improves consistency and efficiency but also gives organizations greater visibility into how PV activities are being managed. This also helps organizations as they seek to scale and expand their portfolio to other regions.
This is avoidable since many PV activities can be centralized and processes standardized to achieve consistent reporting across countries and improve efficiency. Optimizing global, regional, and local pharmacovigilance processes not only improves consistency and efficiency but also gives organizations greater visibility into how PV activities are being managed. This also helps organizations as they seek to scale and expand their portfolio to other regions.
Digital technologies, including artificial intelligence, are central to streamlining PV workflows to reduce manual effort, standardize processes, and minimize errors. Digital innovation also helps to improve reporting and oversight, and can free local and corporate resources to focus on strategic priorities.
Two areas where AI is playing an important role at the local PV affiliate level are adverse event tracking and literature searches.
AI can support tasks such as AE content translation, converting unstructured AE information into structured fields, and suggesting potential article classifications . However, these capabilities are designed to augment efficiency and consistency, not to replace human judgement, with qualified experts remaining within the workflows responsible for review, interpretation, and final decision-making.
When companies face an audit or an inspection, they must be able to show the auditor that their process can be reproduced and that there is a clear audit trail. This can be particularly challenging for multi-country organizations operating within a complex standard operating procedure environment, where differences in local requirements and ways of working can limit visibility and consistency. Use of digitalization can be hugely beneficial but extends beyond AI alone. By replacing manual trackers and fragmented oversight with digital workflows and centralized visibility, companies can maintain end-to-end insight into compliance status while ensuring that key records and process evidence remain traceable and readily available for regulators.
Two areas where AI is playing an important role at the local PV affiliate level are adverse event tracking and literature searches.
AI can support tasks such as AE content translation, converting unstructured AE information into structured fields, and suggesting potential article classifications . However, these capabilities are designed to augment efficiency and consistency, not to replace human judgement, with qualified experts remaining within the workflows responsible for review, interpretation, and final decision-making.
When companies face an audit or an inspection, they must be able to show the auditor that their process can be reproduced and that there is a clear audit trail. This can be particularly challenging for multi-country organizations operating within a complex standard operating procedure environment, where differences in local requirements and ways of working can limit visibility and consistency. Use of digitalization can be hugely beneficial but extends beyond AI alone. By replacing manual trackers and fragmented oversight with digital workflows and centralized visibility, companies can maintain end-to-end insight into compliance status while ensuring that key records and process evidence remain traceable and readily available for regulators.
The final pillar in mitigating risk with local PV activities is communication. In any project plan there needs to be clear delineation on communication responsibility.
Requests, questions, local requirements, and issue escalation should all be handled through a single accountable interface to achieve fast and consistent communication with all PV stakeholders – all with the goal of continuous process improvement.
In addition to issue resolution, it is important to have regular meetings, depending on the stage of the project and the stakeholders involved.
The technical coordinator needs to know what is happening at the different hubs. Regular meetings should be organized between the pharmaceutical project lead, the outsourcing project lead, and the local affiliate teams. Any issues that cannot be resolved through these meetings should be brought to a steering committee for discussion.
These communication channels allow for clear project oversight and more streamlined project planning and problem solving. Importantly, they also build trust between the outsourcing partner, company leads and local affiliates.
Requests, questions, local requirements, and issue escalation should all be handled through a single accountable interface to achieve fast and consistent communication with all PV stakeholders – all with the goal of continuous process improvement.
In addition to issue resolution, it is important to have regular meetings, depending on the stage of the project and the stakeholders involved.
The technical coordinator needs to know what is happening at the different hubs. Regular meetings should be organized between the pharmaceutical project lead, the outsourcing project lead, and the local affiliate teams. Any issues that cannot be resolved through these meetings should be brought to a steering committee for discussion.
These communication channels allow for clear project oversight and more streamlined project planning and problem solving. Importantly, they also build trust between the outsourcing partner, company leads and local affiliates.
Conclusion:
Streamlining the local PV journey
Local PV expertise is essential for companies, but many activities that are not required to remain in-country can be managed more efficiently at a central hub and by leveraging digital technology. When processes and governance are harmonized and local expertise is preserved for country-specific requirements and health authority engagement, the PV workflow becomes more efficient while ensuring local requirements are met.
This harmonization is achieved through well-defined processes, strong governance, and clear communication, thereby addressing the biggest local PV challenges companies face.
This harmonization is achieved through well-defined processes, strong governance, and clear communication, thereby addressing the biggest local PV challenges companies face.
About the author:
José Miguel Rivas Romero is Program Manager, Service Line Lead for Local Pharmacovigilance Services. He has more than 10 years of experience in the pharmaceutical industry specializing in the design and implementation of local pharmacovigilance strategies across organizations.
Clause de non responsabilité :
Les informations fournies dans cet article ne constituent pas des conseils juridiques. Cencora, Inc. encourage vivement les lecteurs à consulter les informations disponibles relatives aux sujets abordés et à s’appuyer sur leur propre expérience et expertise pour prendre des décisions à ce sujet.
