In 2025, pharmacovigilance outsourcing has become essential for biotech companies working to stay compliant and protect patient safety. The European Medicines Agency’s latest report showed a nearly 29% increase in inspections, underscoring the rise in regulatory scrutiny. At the same time, market forecasts predict steady growth in outsourcing as more companies modernize their systems to meet these higher expectations.
For many emerging biotech firms, this means that building a fully compliant in-house pharmacovigilance function is simply unrealistic. As a result, outsourcing has become a practical way to maintain trust, control costs, and keep development on track.
In this article, we’ll explore how outsourcing pharmacovigilance can help biotech companies strengthen compliance, improve patient safety, and stay prepared for the new realities of 2025.
Recent trends influencing pharmacovigilance outsourcing in 2025
Three major trends are significantly influencing how biotech companies approach pharmacovigilance outsourcing in 2025, including a surge in inspections and enforcement, expansion of AI and automation and increased investor scrutiny. Let’s take a closer look:
1. Surge in inspections and enforcement
In June 2025, the EMA published its 2024 annual report, showing that 18 pharmacovigilance inspections were requested by the CHMP or CVMP in 2024, up from 14 in 2023, an increase of nearly 29% (EMA Annual Report 2024). While most pharmacovigilance inspections in the EU and EEA are still conducted under national programs and not captured in these figures, the upward trend highlights growing regulatory oversight. As a result, this steady rise in inspections is prompting more biotech companies to evaluate pharmacovigilance outsourcing as a way to ensure audit readiness and avoid compliance gaps.
2. Expansion of AI and automation
Across the industry, surveys from 2024 and 2025 show that many pharmaceutical and biotech companies are adopting AI-supported pharmacovigilance systems to cut manual work and speed up case processing. For instance, NVIDIA’s 2025 survey found that nearly two-thirds of respondents already use some form of AI technology (NVIDIA Survey 2025). Meanwhile, the Innovative Health Initiative is exploring ways to integrate AI-powered signal detection into safety workflows (IHI Draft Topic May 2025). Because building these capabilities in-house can be costly, many organizations still see pharmacovigilance outsourcing as the most practical way to access advanced tools and expert support. This trend is also reflected in the DIA Global Forum’s 2024 survey, which found that more companies are turning to external partners to modernize their pharmacovigilance systems (DIA Global Forum 2024).
3. Increased investor scrutiny
Investors are raising the bar. As regulatory scrutiny tightens and development costs rise, more companies are modernizing their pharmacovigilance strategies earlier in the product lifecycle. Not surprisingly, market research shows that pharmacovigilance outsourcing is growing fast, with the global market expected to jump from $6.16 billion in 2024 to $7.24 billion in 2025 (The Business Research Company). This surge reflects both regulatory demands and investors’ preference for companies that can prove they have reliable, scalable compliance systems. Ultimately, a strong pharmacovigilance strategy, backed by the right technology and expert partners, is becoming an essential marker of credibility in 2025 (Data Insights Market, IQVIA Trends 2025).
Challenges of managing pharmacovigilance internally and why outsourcing works
While managing pharmacovigilance internally might seem feasible at first, most biotech companies quickly encounter challenges like limited expertise, stretched resources, rising compliance pressure, and the need for validated technology. Nowadays, regulators expect documented processes, validated systems, and inspection readiness from day one.
So, when should a biotech company consider outsourcing pharmacovigilance?
Many companies start outsourcing before commercial launch to establish validated systems and ensure readiness for inspections. If you lack in-house expertise or need scalable resources, outsourcing is often the most efficient approach
The reality is that pharmacovigilance outsourcing can provide a structured, proven way to meet expectations without draining internal bandwidth:
- Standardized Processes and Documentation: Leading providers maintain SOPs fully aligned with EMA GVP Modules and FDA requirements, ensuring every safety report is complete and consistent.
- Regulatory Intelligence: Partners proactively monitor evolving guidelines and adjust workflows to keep you compliant as standards change.
- Validated Technology: Secure platforms like Veeva Vault Safety capture, process, and store data reliably, reducing errors and audit risks.
- Audit and Inspection Readiness: Clear documentation and trained teams mean you’re prepared for regulatory reviews without scrambling for evidence.
- Scalable Resources: As your pipeline grows, outsourcing makes it easy to expand support without costly internal hiring or retraining.
How pharmacovigilance outsourcing reinforces patient safety?
Beyond compliance, pharmacovigilance outsourcing reinforces the core mission of every biotech company: patient safety. In 2025, regulators and healthcare professionals expect nothing less than real-time vigilance across global markets.
Experienced outsourcing partners provide:
- Advanced signal detection: AI-powered tools help identify emerging safety trends early, so you can act before issues escalate.
- Proactive risk management: Dedicated safety teams monitor data continuously, flagging potential concerns and guiding mitigation strategies.
- Timely safety communication: Consistent workflows ensure important safety updates reach healthcare providers and patients quickly.
- Patient trust: A reliable safety monitoring system demonstrates transparency and builds confidence among stakeholders.
Therefore, by investing in an outsourced pharmacovigilance system, you’re demonstrating a commitment to patient well-being that builds trust with regulators, investors, and clinicians.
Choosing the right pharmacovigilance partner
Selecting the right pharmacovigilance partner is critical in order to achieve success in all the challenges above. A good pharmacovigilance outsourcing partner should become an integrated extension of your team.
Look for pharmacovigilance partners who provide:
- Deep experience with emerging biotech companies and complex products
- Qualified Persons for Pharmacovigilance (QPPVs) with proven track records
- Validated safety databases and secure technology platforms
- Transparent processes and proactive communication
- Global coverage and 24/7 operational support
Conclusion
To conclude, in 2025, pharmacovigilance outsourcing it’s a strategic investment in patient safety, regulatory compliance, and operational efficiency. With the right partner, you can meet evolving global standards, protect your reputation, and keep your resources focused where they matter most: developing innovative therapies.
Ready to learn more?
Explore Biomapas Pharmacovigilance Services or Contact our team to discuss how outsourcing can work for your organization.
