Building a Local Safety Officer, Local Person Responsible Pharmacovigilance Program

Key Considerations and Best Practices 

Introduction 

Beth Shaleesh, RN, MS, MBA, Head of Pharmacovigilance Account Management for North America, delivered an insightful presentation on the fundamental considerations involved in building a Local Safety Officer (LSO) or Local Person Responsible for Pharmacovigilance (LPRP) program. This presentation highlighted the significance of correctly establishing such programs and the myriad of benefits they provide to organizations in terms of compliance, efficiency, and public health protection. 

Importance of the LSO Program 

As global regulations become more complex and more products are marketed globally, the LSO program is indispensable for several key reasons. First, it is a legal requirement in many countries around the world to fulfil the local pharmacovigilance regulations. These legal stipulations ensure that companies remain compliant with local, regional, and international pharmacovigilance regulations, thereby avoiding legal repercussions and fines. Second, an effective LSO program works closely with the Marketing Authorization Holder (MAH) to equip organizations with the expert knowledge necessary to navigate the evolving pharmacovigilance landscape and complex global regulations. Third, one of the primary goals of the LSO program is to minimize risk. By ensuring that all pharmacovigilance activities are conducted accurately and timely, the program helps protect patient safety and public health, thereby enhancing the organization’s reputation and trustworthiness. Finally, the LSO program serves as a crucial support system for the MAH’s pharmacovigilance activities. By acting as a local expert, the program ensures that the MAH’s obligations are met efficiently and effectively. The LSO program encourages a strong partnership with the MAH, aiming to meet and exceed the MAH’s objectives. This collaboration extends to supporting competent authorities’ inspections and ensuring that all pharmacovigilance activities are transparent and compliant. 

Key Considerations 

When embarking on the journey of building an LSO/LPRP program, several critical considerations must be addressed. It is essential to ensure that the vendor chosen for the LSO program has a global presence and resources in locations that align with the organization’s future growth requirements. This will help reduce/eliminate the need for multiple vendors and more complex oversight in the future. Considerations should also include whether the services are subcontracted, performed by vendor staff, or a mix of both, and how oversight of these operations is managed. A well-thought-out organizational structure that maximizes support by incorporating a global reach with a local acting model requires regional coordination, oversight, and global governance. With these in place, it will facilitate process harmonization and maximize performance quality, efficiency and cost-effectiveness.  

PLG deploys an LSO Coordinator (LSOC) to serve in this capacity. With 5 to 10 years of experience in team management and pharmacovigilance operations, a science-related degree, excellent organizational and interpersonal skills and effective communication abilities to ensure smooth and efficient operations, the LSOC begins work on the project during the transition phase (prior to go live), assisting the team to mitigate risks and ensure that the project starts on the right footing, paving the way for long-term success. Working with the client and PLG stakeholders, the LSOC is instrumental in developing and managing a transition plan which is vital to timely and precise project implementation thereby, minimizing disruptions and ensuring continuity of operations. The partnership and client support continues post go-live allowing the client partner to minimize oversight demands and have a single point of support when working with global model complexities. 

PLG’s LSO/LRPPV Offering 

Under the guidance of the LSOC, PLG offers comprehensive services that encompasses several key elements. These services include but are not limited to: 

• Fulfillment of the a nominated contact person for National Health Authority who assists the  Marketing Authorization Holder (MAH) to oversees the local pharmacovigilance system and backup system, ensuring that all processes are in place and functioning correctly..  

• Monitoring of official authority websites for safety information that may impact the organization’s products or operations. 

• Pharmacovigilance audit and inspection support  

• Assistance with safety-related communications, ensuring that all actions are carried out promptly and efficiently.  

• Pharmacovigilance training ensuring that all team members are knowledgeable and compliant with regulatory requirements.  

• Local case management activities, processing of safety information from receipt, triage, translation of local source documents to submission of ICSR to local health authorities 

• Performing local literature screening of local journals for identification of safety information 

• Processing Medical Information inquiries, handling product complaints, adverse event reporting, submissions, and report writing   

Case study 

A noteworthy case study involves a global pharmaceutical company that partnered with PLG to manage its local pharmacovigilance (PV) and regulatory activities across more than 40 countries, including regions in the EU, MENA, JAPAC, and the Americas. The scope of services included the nomination of local responsible persons, local regulatory intelligence, literature surveillance, ICSR case management, and additional support such as RMPs, PSUR submissions, aRMM implementation, and PV training. 

Challenges and Actions Taken 

The implementation of this global affiliate outsourcing program faced several challenges, notably the need for a seamless transition of local oversight and the ability to adapt to evolving affiliate needs. PLG addressed these by: 

• Selecting experienced local PV specialists and qualified vendors to ensure compliance and efficiency. 

• Rapidly setting up a global operating model with regional coordination and global governance. 

• Developing innovative tools such as a local ICSR tracking system and automated reconciliation solutions. 

• Implementing global and local pharmacovigilance technical agreements (PVTAs) to harmonize responsibilities and ensure consistency across affiliates. 

Post Go-Live Monitoring 

Following the go-live, PLG established a robust monitoring framework that included: 

• Centralized tracking of all local ICSR activities to enable global HQ oversight. 

• Monthly performance reports and governance meetings to ensure transparency and quick issue resolution. 

• Continuous monitoring of KPIs, all of which have been successfully met to date. 

Current Project Status 

Since its inception, the project has scaled significantly, now involving 48+ PLG experts, including hybrid PV/RA resources. Over 1,000 local ICSRs were managed in the first eight months alone. The client’s satisfaction has led to ongoing expansion of the program in some of its key markets, reinforcing PLG’s role as a trusted partner in global PV and regulatory support. 

Conclusion 

This case study highlights the importance of building a scalable and compliant LSO/LPRP program. By leveraging experienced personnel, innovative tools, and a flexible operating model, PLG has demonstrated its ability to meet complex local and global pharmacovigilance requirements while maintaining high standards of quality and client satisfaction. 

For more information or to discuss how PLG can support your organization in building an LSO/LPRP program, please contact our team.