Outsourcing of the PV function for a growing pharmaceutical company

Client situation

The company has historically managed PV cases for marketed products using Excel-based tracking. As part of its growth strategy, the company is continuously acquiring new companies and adding products to its portfolio, increasing the volume and complexity of its PV activities. The company now needs to implement a dedicated Patient Safety Database and migrate its existing PV cases and relevant safety data into the new system. The company currently has one senior person responsible for PV, Regulatory and QA. With the growing product portfolio, this person can no longer manage all activities independently. The company therefore needs additional support with QPPV and d-QPPV responsibilities, as well as Medical Information, to ensure sufficient capacity and appropriate oversight as the business continues to grow.

Client challenge

Rapid growth through acquisitions has significantly increased the company’s product portfolio and PV workload.
PV cases for marketed products have historically been managed using Excel, creating a need for a more structured and scalable solution.
The company has limited internal resources, with one senior person covering PV, Regulatory and QA.
Additional support is needed for QPPV and d-QPPV responsibilities, as well as Medical Information, to ensure sufficient capacity and appropriate safety oversight.

PharmaRelations’ solution

Implemented a dedicated Patient Safety Database and supported the migration of existing PV cases and safety data from Excel.
Set up and maintained PV cases in the Patient Safety Database through PharmaRelations’ in-house intake team.
Provided QPPV and d-QPPV support to strengthen the company’s pharmacovigilance oversight and capacity.
Provided Medical Information support to manage increasing product-related enquiries.
Established an intake process for Medical Information cases.
Established a scalable PV setup that can support the company’s continued growth through acquisitions and expanding product portfolio.
Operated in accordance with PharmaRelations’ Quality Management System, SOPs and established processes.

Implementation approach

The implementation was designed to establish a scalable and compliant Patient Safety operating model capable of supporting the company’s continued growth. PharmaRelations first implemented a dedicated Patient Safety Database and managed the migration of existing PV cases and safety data from Excel into the new system. This created a more structured and sustainable foundation for pharmacovigilance activities. At the same time, PharmaRelations assumed key operational responsibilities, including case management, QPPV and d-QPPV support, and Medical Information services. Medical Information intake processes were established, and all activities were managed according to PharmaRelations’ Quality Management System, including SOPs and established PV processes. The solution provided the client with immediate operational support, regulatory oversight and flexibility to scale resources as the product portfolio continued to expand.

Outcome for the client

The client gained a compliant, scalable and future-proof Patient Safety set-up without the need to build a larger internal organisation. The implementation of a dedicated Patient Safety Database improved traceability, efficiency and compliance, while reducing reliance on manual Excel-based processes.

By outsourcing key PV and Medical Information activities, the client ensured access to experienced pharmacovigilance specialists, QPPV and d-QPPV support, and established quality processes. This reduced the workload on the internal compliance lead and created a sustainable operating model capable of supporting future acquisitions and portfolio growth.

Improved compliance
Reduced operational risk
Reduced internal workload
Scalable support model

Key success factors

Implementation and migration to a dedicated Patient Safety Database.
Access to both operational PV support and senior specialist expertise, including QPPV and d-QPPV services.
Medical Information support with established intake and case management processes.
Reduced workload and increased focus for the client's internal PV, Regulatory and QA lead.
Access to PharmaRelations’ established QMS, SOPs and compliant PV processes.
Scalable outsourcing model capable of supporting future acquisitions and portfolio expansion.

What this case demonstrates

This case demonstrates PharmaRelations’ ability to build and operate a complete Patient Safety solution by combining technology, processes and specialist expertise. By implementing a dedicated safety database, providing QPPV and Medical Information services, and operating within a robust quality framework, PharmaRelations enabled the client to move from a resource-constrained, Excel-based setup to a scalable and compliant pharmacovigilance model. The solution reduced operational risk, strengthened compliance and created a platform capable of supporting long-term business growth.

“PharmaRelations helped us move from a resource-intensive, Excel-based setup to a structured and scalable Patient Safety model. We now have the systems, processes and expertise in place to support our continued growth with confidence.”