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.”

Nordic Market Entry with Scalable Cross-Functional Support

Client situation 

The client was a large Asian life science company with an established presence in selected European markets. The company wanted to establish its first Nordic presence in Denmark, with a local office in Copenhagen connected to its existing European organisation. The ambition was to start with a lean Danish setup and gradually expand into the other Nordic markets as the business developed. 

Client challenge 

The client needed to establish a compliant and efficient Nordic foundation before launching and scaling its commercial operations. The initial focus was on understanding the regulatory requirements, preparing for market entry and establishing the necessary local compliance infrastructure. At the same time, the client wanted to avoid building a large, fixed organisation too early. As the business progressed, it would need access to local expertise across Regulatory, Market Access, QA and PV, as well as recruitment and interim support to build the commercial organisation and gradually establish its own Nordic capabilities.

PharmaRelations’ solution

PharmaRelations provided a stepwise Nordic market entry model, starting with Regulatory and compliance and gradually expanding into Market Access, QA, PV, recruitment and commercial support. The initial phase focused on the Danish market, including regulatory strategy, market entry planning, local requirements and the establishment of the necessary quality and pharmacovigilance infrastructure. PharmaRelations also supported Market Access activities, including pricing and reimbursement considerations.

As the client moved closer to commercial launch, PharmaRelations supported the build-up of the local organisation through recruitment, interim resources and commercial expertise. This enabled the client to establish the first local roles while maintaining flexibility and avoiding a large, fixed organisation from day one. Once the Danish setup was established, the same cross-functional model could be scaled to additional Nordic markets, combining local country expertise with a coordinated Nordic approach.

Implementation approach

The implementation followed a phased approach:

Phase 1 – Regulatory, Market Access & Compliance Set-up

• Regulatory strategy, dossier due diligence and Nordic launch planning, starting with Denmark.
• Marketing authorization activities, local product information, translations and submission support.
• Market Access assessment, including pricing and reimbursement strategy and launch sequencing.
• QA set-up, including QMS, SOPs, training, supplier qualification and audit readiness.
• PV set-up, including local safety processes, local contacts and safety activities.
• Establishment of the local roles and governance needed to support the Nordic launch.

Phase 2 – Commercial Launch & Organisation Build

• Development of the commercial launch plan and Nordic operating model.
• Interim commercial, sales, marketing and medical support as required.
• Recruitment of the first local employees and specialists.
• Executive Search and specialist recruitment across the Nordic markets.
• Use of interim and try-and-hire solutions to test and scale the organisation.
• Gradual expansion from Denmark into additional Nordic markets based on launch plans and business needs.

Outcome for the client 

The client was able to establish a local Nordic presence in Denmark with a controlled and scalable approach, starting with the regulatory and compliance foundation before building the commercial organisation. The model provided access to the required Nordic expertise without the need to establish all functions internally from the beginning. As the business developed, PharmaRelations could support the transition from regulatory and compliance activities into commercial launch, recruitment and organisation building. The approach also created a platform that could be extended to other Nordic countries, allowing the client to scale its presence in line with regulatory approvals, market access milestones and commercial needs.

• Faster and more structured market entry
• Reduced market-entry risk and fixed organizational commitment
• Access to cross-functional Nordic expertise
• Flexible transition from outsourced/interim support to internal capabilities
• Scalable model for expansion across the Nordic markets

Key success factors

• Regulatory-first approach to establish the foundation for Nordic market entry.
• Strong local knowledge of Danish and wider Nordic regulatory and market access requirements.
• Cross-functional support across Regulatory, Market Access, QA and PV.
• Recruitment and interim solutions introduced as the commercial organisation was built.
• Flexible model allowing the client to test and scale its Nordic organisation.
• One coordinated partner supporting the transition from market entry to commercial launch and further Nordic expansion.

What this case demonstrates 

This case demonstrates PharmaRelations’ ability to support international life science companies throughout the journey from Nordic market entry to commercial organization build-up. By combining Regulatory, Market Access, QA, PV, recruitment, consultancy resources and commercial expertise, PharmaRelations can provide a flexible and scalable model that starts with a compliance foundation in Denmark and expands with the client across the Nordic markets.

“PharmaRelations became an extension of our organisation in the Nordics. Their combination of local market knowledge, cross-functional expertise and flexible resources gave us a strong foundation in Denmark and a clear path for further Nordic expansion.”

Scalable recruitment support for a growing Swedish start-up

Client situation

The client was a small but rapidly growing Swedish life science company that expected to recruit several important functions over a period of a few years. The company needed to scale up its organisation but had limited financing and wanted to avoid building fixed internal HR and recruitment capacity before there was a full-time need.

Client challenge

The client needed access to professional recruitment support across several functions, while maintaining cost control and flexibility. Employing a full-time HR or Recruitment Manager would have created a fixed cost that was difficult to justify at the company’s stage of growth. At the same time, the client needed faster recruitment processes, better forward planning and access to specialist knowledge about the Nordic life science talent market.

PharmaRelations’ solution

PharmaRelations proposed a three-year recruitment service with one dedicated resource responsible for understanding the client’s needs, coordinating recruitment activities and planning upcoming hires well in advance. This long-term model enabled faster start-up of each recruitment process and gave the client continuous access to recruitment expertise without the cost of a full internal function.

In addition, PharmaRelations proposed interim solutions for selected functions to increase agility and reduce hiring risk. As the relationship developed, the dedicated contact also introduced the client to broader PharmaRelations expertise, including access to specialist resources in Denmark and potential support within Market Access and other business areas.

Implementation approach

The collaboration was built around regular forward-looking discussions between the client and the dedicated PharmaRelations contact. Rather than starting each recruitment from zero, PharmaRelations continuously monitored future needs, market availability and relevant competence profiles. This enabled the client to plan recruitment earlier, accelerate processes when needed and use interim expertise as a flexible bridge where appropriate.

Outcome for the client

The client avoided the cost of employing a full-time recruitment manager while still gaining access to structured, professional recruitment support. PharmaRelations’ fees represented approximately half the cost of an internal manager, while the flexible model increased the pace of growth and improved the client’s understanding of available expertise in the Nordic market. The long-term agreement also saved time for both parties and created a more efficient recruitment process over time.

• Cost reduction
• Faster recruitment
• Increased flexibility
• Access to specialist talent insight

Key success factors

• A long-term recruitment agreement that created continuity and speed.
• One dedicated contact responsible for coordination and planning.
• Cost-efficient access to recruitment expertise without building a fixed internal HR function.
• Flexible use of interim expertise to support growth and reduce risk.
• Access to specialist competence across Nordic markets and PharmaRelations business areas.

What this case demonstrates

This case demonstrates how PharmaRelations can support growth companies with scalable, cost-efficient and long-term recruitment solutions. By combining dedicated account management, recruitment expertise, interim flexibility and access to broader Nordic specialist capabilities, PharmaRelations helped the client grow faster while maintaining financial control and organizational agility.

“PharmaRelations gave us the recruitment expertise we needed without having to build a full internal function. Having a dedicated partner who understands our business and plans ahead has made our recruitment faster, more flexible and better aligned with our growth.”