As the demand for pharmacovigilance (PV) activities grows and health authorities like the European Medicines Agency (EMA) tighten their inspection requirements, local affiliates face mounting pressure. This increasing demand underscores the need for efficient best practices to manage local PV activities. Drawing on global market experience, we explore best practices from a people, platform, and process perspective to help organizations streamline local PV requirements.
Focusing on People at the Local Level
Local pharmacovigilance (PV) activities require ongoing oversight, and ensuring this continuity is critical for compliance with regulatory standards. As the person responsible for PV at the local level, backup is essential to ensure adequate coverage during time off or staff turnover. Health authorities like the EMA explicitly demand 24/7 oversight, meaning onboarding should be efficient and straightforward. A solid handover plan with clear instructions and regular training ensures uninterrupted PV activity.
For large companies operating across multiple countries, having a team of skilled professionals is essential. For example, in a company with operations in 100 countries, at least 200 local PV professionals would be required to maintain ongoing activities. This demands frequent training and onboarding to keep the team well-prepared and compliant with regulatory standards.
The individuals handling these responsibilities must possess experience that extends beyond literature searches and case safety reports. They should be able to address issues related to risk minimization, patient support programs, and signal detection for medical devices and cosmetics. These responsibilities make it clear that the role should not be assigned to inexperienced staff. In addition, these local PV personnel will serve as the primary contact for regulatory authorities and must be prepared to manage inspections.
A significant challenge is the shortage of skilled PV professionals. To overcome this, many companies are turning to outsourcing partners that can scale with local and global needs. These partnerships allow companies to leverage local expertise for specialized PV activities, while centralizing certain functions like literature searches for efficiency. Depending on the organization’s needs, a hybrid outsourcing model, where some roles are outsourced in certain countries, might be the most effective approach.
Streamlining Local PV Platforms and Processes
Most pharmaceutical companies operate a global PV system, but each country may have specific components like local Standard Operating Procedures (SOPs) and guidance’s. From experience, we have seen that these local procedures often are not fully integrated into the company’s Quality Management System (QMS). It is crucial that these local processes are relevant, validated, and compliant, and that there is potential for harmonizing them with global standards.
A key tool for managing these local processes is a robust training matrix, which helps plan, track, and manage PV curriculum training for both internal and external PV personnel. The importance of this is clear. If companies choose to outsource or handle PV activities internally, all personnel internal and external should have access to the same training. This integration ensures that external contractors are well-supported and aligned with internal teams, reducing siloed operations.
One common issue at the local level is the use of disparate Excel trackers to manage PV activities. In large companies, each affiliate may use different trackers for various PV workstreams. This results in a chaotic, unmanageable system of trackers scattered across numerous country folders leading to inefficiencies and errors.
A solution to this is adopting a unified, validated digital platform that can manage the entire local PV system. Such platforms enable easier tracking of data, provide a clear overview of all local PV activities, and allow for automation of reporting tasks, such as generating consolidated PV reports. This can provide the EU Qualified Person for Pharmacovigilance (EU QPPV) with insights into PV activities across EU markets, which is essential for maintaining a compliant and efficient PV system.
Addressing Local Concerns and Managing Expectations
When choosing to outsource local PV services, companies must consider the expectations of local affiliates. Often, affiliates have established relationships with local consultants and may be hesitant to change service providers. A clear change management program is essential to communicate the decision to use a particular service provider and to ensure affiliates understand the reasoning behind it.
Equally important is defining the roles and responsibilities of both the service provider and internal teams. Clear communication regarding which activities will be managed by the outsourcing partner and which will remain internal is critical for the successful implementation of local PV services. Headquarters must work closely with local affiliates to ensure their concerns are addressed and to gain their buy-in for outsourcing initiatives.
Preparing Local Affiliates for Outsourced PV Services
Many organizations are increasingly consolidating outsourced PV activities under a single service provider instead of managing multiple vendors in each country. While this strategy can bring efficiency and consistency, it is important to prepare local affiliates adequately. This includes providing appropriate training, ensuring effective communication, and integrating external resources into the company’s operations.
By giving local affiliates a thorough understanding of the change and ensuring they have the necessary resources and support, companies can make the transition smoother and more successful. Establishing clear, standardized processes will also help facilitate the integration of outsourced services into the organization’s global framework.
Partner with BioBoston Consulting for Optimized Pharmacovigilance Solutions
At BioBoston Consulting, we specialize in helping organizations manage local pharmacovigilance activities in compliance with global regulations. Whether you are navigating the complexities of outsourcing or looking to streamline your internal processes, we offer tailored solutions to optimize your PV operations. Our experts provide support in everything from training and integration to platform management, ensuring your local PV activities run efficiently and are fully compliant with regulatory standards.
Contact BioBoston Consulting today to learn how we can support your pharmacovigilance needs and help you navigate the challenges of local PV operations.