How to Build a Compliant Pharmacovigilance System for Growing Biotech Companies in Clinical Development

As small and mid-sized biotech companies accelerate product development and move into first-in-human or early clinical phases, establishing a robust and compliant pharmacovigilance (PV) system becomes critical — both for regulatory compliance and patient safety.

This article is specifically aimed at growing biotech in clinical development — whether initiating a first-in-human trial or progressing through Phases I–III — and outlines the key considerations for forward-planning a scalable, audit-ready PV system ahead of marketing authorisation.

🔍 Key areas covered:

• Regulatory obligations (EU, UK, US)

• PV roles & strategic resourcing

• Safety databases & vendor partnerships

• Core SOPs and documentation

• Inspection readiness

________________________________________

1. Understand Your Regulatory Obligations

Before designing your PV system, understand which regulations apply — globally and at local level. Examples include:

• EU GVP Modules I–XV (for EU/EEA trials or marketing)

• FDA PV Requirements under 21 CFR 312, 314 (for U.S. trials/approvals)

• MHRA guidance for UK clinical trials and post-marketing activities

Your obligations depend on the development phase, trial locations, and regulatory strategies. In addition to overarching frameworks, some countries have local pharmacovigilance requirements — such as local QPPV or local reporting obligations.

Start with a gap analysis to identify what’s required versus what’s already in place.

💡 Tip: Using a PV vendor with robust regulatory intelligence capabilities can help you to stay compliant with evolving global safety requirements.

________________________________________

2. Appoint Key PV Roles Early

Even if you’re not building a full team yet, the following roles should be considered:

• Drug Safety Officer or PV Consultant – to oversee day-to-day PV operations, manage vendors, and coordinate cross functionally with internal teams e.g. Clinical, QA, Regulatory, Data Management.

• Safety Scientist or Signal Detection Specialist – to monitor, analyse, and evaluate any potential emerging safety signals.

• Safety Physician or Medical Reviewer – to assess adverse events and ensure medical oversight of the investigational medicinal product (IMP).

• QPPV and/or NCPPV – plan for these roles ahead of marketing authorisation. Country-specific rules may require the QPPV to be based locally, medically qualified, or have specific experience.

📑 Ensure PV agreements clearly define responsibilities, communication pathways, KPI’s and compliance expectations.

________________________________________

3. Establish a Fit-for-Purpose Safety Database

Choose a validated pharmacovigilance safety database that meets your size, budget, and reporting needs:

• Early phase: Use a cost-effective, validated, vendor-hosted solution that enables ICSR intake, assessment, MedDRA coding, and regulatory submission.

• Later phase or commercial: Ensure the system can scale to support aggregate reporting, signal detection, and global regulatory compliance. Consider hosting your own validated database to overcome any data access issues.

⚠️ Ensure compliance with:

• 21 CFR Part 11 (FDA)

• EudraLex Volume 4 Annex 11 (EU)

• Applicable UK or country-specific data security standards

Clarify data access and ownership in vendor contracts to avoid any downstream issues.

________________________________________

4. Establish Essential PV SOPs and Workflows

Even lean PV operations must be supported by robust documentation. Key SOPs may include:

• Safety Governance

• SAE collection, assessment, and follow-up

• Aggregate report generation (e.g., DSURs, PSURs)

• Signal detection and risk management

• SAE reconciliation and trending

• Vendor oversight (for CROs or PV service providers)

Also consider developing your Pharmacovigilance System Master File (PSMF) and developmental Risk Management Plan (dRMP) early. Both are required for EU/UK marketing authorisation applications and help demonstrate readiness for marketing approval.

________________________________________

5. Build Strategic Oversight and Partnerships

If outsourcing pharmacovigilance:

• Conduct due diligence when selecting a PV vendor

• Define KPIs, reporting metrics, and compliance expectations

• Schedule regular review meetings and audits

• Ensure you retain access to data and maintain oversight

🌱 As your pipeline grows, reassess whether certain PV functions should be brought in-house.

________________________________________

6. Plan for Inspections and Compliance

Regulators (MHRA, EMA, FDA) may inspect even during early clinical phases — especially if you're running trials globally.

📋 Inspection-readiness checklist:

• Up-to-date SOPs, SMPs and role-based training records

• Clear audit trails in your safety database

• Signed and current Safety Data Exchange Agreements (SDEAs)

• Documented signal and risk evaluation processes

________________________________________

Final Thoughts

Building a compliant pharmacovigilance system doesn’t have to be overwhelming.

With the right planning, partnerships, and phased implementation, small biotech and pharmaceutical companies can create lean but robust PV frameworks that support growth, satisfy inspection criteria, and most importantly — help protect patients.

If you’re a growing biotech looking to establish or enhance your PV system and need support, feel free to reach out. Drug Safety Services can provide tailored solutions and flexible resourcing to meet your needs.

________________________________________

🗓️ This blog reflects MHRA, FDA, and EMA regulatory guidance as of April 2025. Always consult updated guidance or your regulatory team when planning your pharmacovigilance activities.

If you have questions about your responsibilities or need support with pharmacovigilance activities, feel free to contact me at amanda@drugsafetyservices.co.uk or connect via LinkedIn.