How Pharmacovigilance Experts Build Trust With Regulators, Partners, and Internal Teams

Trust is essential to effective pharmacovigilance. PV professionals rely on credibility, transparency, and sound judgement when working with regulators, healthcare professionals, partners, and internal teams.

But what does trust look like in practice? In this interview, an experienced pharmacovigilance professional shares practical insights on building trust, handling uncertainty, working with regulators, and balancing technology with human judgement.

Why Trust Matters in Pharmacovigilance

In pharmacovigilance, trust is not simply a soft skill. It supports patient safety, regulatory compliance, and effective collaboration across the pharmaceutical ecosystem. PV professionals often work with incomplete data, tight timelines, and decisions that can have significant consequences. Strong relationships between stakeholders help teams navigate this environment and work together effectively.

Trust, Patient Safety, and Healthcare Professionals

Trust in the pharmaceutical industry is closely linked to patient safety. Patients and healthcare professionals need confidence that medicines are continuously monitored and emerging safety concerns are identified, evaluated, and communicated appropriately. This depends on reliable safety data, transparent communication, and robust post-marketing surveillance.

Doctors, nurses, and pharmacists rely on pharmaceutical companies and PV teams for accurate and timely safety information. Clear communication helps healthcare professionals make informed decisions and respond appropriately to emerging risks.

Trust and Regulatory Collaboration

Trust also plays an important role in interactions with regulatory authorities. Transparency, high-quality data, and well-documented safety assessments help build confidence and support constructive regulatory collaboration.

The Role of PV Teams

Pharmacovigilance teams sit at the centre of these relationships. Through continuous safety monitoring, rigorous data evaluation, and clear communication, they connect pharmaceutical companies, regulators, healthcare professionals, and other stakeholders. Consistent and transparent handling of safety information helps sustain trust across the drug safety system.

How PV Experts Build Trust in Practice

To better understand how trust is built in pharmacovigilance, we spoke with Erika Barbarosie, Associate Director, PV Compliance at Gilead Sciences. As a Lead GVP Auditor and EU/EEA Qualified Person for Pharmacovigilance (QPPV), Erika brings extensive expertise in safety profile oversight, emerging safety concerns, PV compliance, audits, inspection readiness, and cross-functional collaboration across multiple therapeutic areas.

In the conversation below, she shares her perspective on building strong relationships with regulators, partners, and internal teams, while explaining what it takes to earn and maintain trust in day-to-day pharmacovigilance practice.

DrugCard: Let’s start with the basics – what does trust mean to you in the context of pharmacovigilance, and why is it so critical?

Erika: Trust is a complex and multi-layered aspect of our industry. We are building relationships with partners, regulators, and healthcare professionals to ensure their confidence in the data we generate, our safety data evaluation practices, the speedy delivery of the latest scientific information, and the prompt escalation of any concerns that ultimately, we are working for the patients. It is not simply an obligation, but it should be the ethos as well.

Additionally, it is critical how we engage with the stakeholders, how transparently we communicate during the interactions, and the quality of our data. Losing out on these practices can escalate quicker than we think and has the potential to result in preventable harm. So the consideration of trust should be there in every action, every decision, every task, and every communication we make.

DrugCard: How do you build trust with regulatory authorities when dealing with complex or ambiguous safety information?

Erika: One way you can facilitate rapport is to be proactive, transparent and have the required scientific rigour in place. Being laid back, reactive, and waiting for the authorities to detect safety issues and approach you is the least favourable strategy.

The quality of safety data in our industry is crucial. We all know the saying: “garbage in, garbage out”. Therefore, making every effort to collect, collate, and aggregate high-quality safety information is a must. That enables other linked, critical processes and decisions to be adequately made. When assessors see that a company does not hide behind ambiguity, but instead applies rigorous methodology and reports what is known, what is unknown, and what is done to gather further information, the assessors happily partner up with such companies and guide them further.

DrugCard: What approaches help you maintain open and honest communication within internal teams and with external partners?

Erika: In both cases, there have to be clear operational structures in place, accountability, and a “no-blame” culture focused on patient safety – always remember, we are working for the patients, whether directly or indirectly. Just as a drug “doesn’t know” whether it is in one or the other country, patient safety practices should be a joint global effort – a strong safety net without borders.

Internally, it is important to foster a company culture where departments work together rather than in silos, and raising safety concerns is rewarded rather than penalised. Similarly, in partnership, company alignment, escalation and communication, visibility, and building a dynamic are all key for success.

DrugCard: Can you share a real-life situation where trust played a decisive role in preventing a safety issue or resolving a critical challenge?

Erika: One classic is when, during post-marketing surveillance, a cluster of AEs reported suggested a potential batch-related issue or medication error rather than an intrinsic drug toxicity.

The company had a sudden spike in reports of local injection site reactions for a product. Rather than treating these as routine ICSRs under standard timelines, the safety team immediately escalated, and the PV department convened an ad-hoc Safety Committee meeting.

During the exercise, as we already had an established and good relationship with the manufacturing colleagues, they had no problem joining the discussion and sharing their internal manufacturing and distribution metrics immediately.

Simultaneously, we engaged with the relevant competent authorities. Through open dialogue and the appropriate investigation, it came to light that the issue stemmed from improper administration technique and cold-chain storage deviations rather than product contamination. Because of established rapport with the regulators, we were able to quickly implement targeted educational materials and a DHPC, preventing unnecessary product recalls while safeguarding patients.

DrugCard: Pharmacovigilance teams increasingly work with large datasets, digital tools, and automated processes. How do you combine technology with the human factor to maintain trust?

Erika: We need to keep in mind that technology is a tool for efficiency, not a substitute for clinical judgment. Automation and AI change where trust needs to be placed, not whether it’s needed.

When implementing such tools and advancing your processes, validation, transparency, monitoring for drift, and decision-making are key. We have different operational models for how we ensure the human in the loop; however, we cannot omit that. Technology streamlines and facilitates processing, but human expertise interprets risk and makes the decision. The higher the consequence of a wrong output in a patient safety decision, the more rigorous control you need – see the latest MHRA and FDA advocacy. Luckily, our industry now has several guidelines available on best practices to implement technology.

Remember:

• Principles hold, practice extends;
• Intended use is the anchor;
• Scale depth to risk;
• and accountability does not transfer.

Trust in the technology is earned the same way trust in a person is: through consistent, verifiable performance over time, not a one-off validation exercise.

DrugCard: Based on your experience, what advice would you give to early-career PV professionals who want to become trusted and reliable contributors to their organisations?

Erika: First and foremost, have a holistic understanding: it is important to know what you need to do, but it is equally important to know why you do it.

• Apply critical thinking.
• Be the person who flags issues, ambiguity, and uncertainties.
• Document your rationale proactively.
• Never stop learning: there are plenty of ways to execute a process.
• Be transparent.
• And never lose sight of the patients. You, your loved ones, everyone becomes a patient at one point. Let’s do our jobs in a way that we would like to be safe as patients. 

Closing Thoughts

The interview offers a practical look at what makes a PV professional reliable when safety decisions are not always straightforward.

One key takeaway is to be proactive rather than reactive. Good PV practice means identifying concerns early, escalating when needed, and involving the right people before an issue becomes critical.

Another is the importance of good-quality data. Sound safety decisions depend on collecting reliable information, documenting the rationale, and being clear about what is known, what is uncertain, and what still needs to be investigated.

The conversation also highlights an important point about technology. AI and automation can support PV teams, but they do not replace professional judgement. Human oversight, appropriate validation, and clear accountability remain essential as these tools become part of everyday PV work.

For early-career professionals, Erika’s advice is straightforward: understand not only what you are doing, but why. Keep learning, question ambiguity, document your reasoning, and speak up when something does not look right.

These habits may be simple, but they are what help turn PV knowledge into sound professional judgement.