The pharmacovigilance landscape is facing dynamic changes and challenges that require sophisticated solutions. As the industry confronts an increase in adverse event reporting due to growing disease complexity, pharmacovigilance service providers like PrimeVigilance are more essential that ever in navigating this evolving terrain. With advancements in artificial intelligence (AI) and an influx of data from wearable technology, there is a unique opportunity to revolutionize adverse event detection and reporting. In this Q&A, PrimeVigilance President Sally Amanuel and Pharma’s Almanac Editor in Chief David Alvaro, Ph.D., discuss how PrimeVigilance is addressing these industry shifts by offering strategic support and harnessing cutting-edge technology to efficiently support pharmacovigilance needs within an increasingly complex healthcare system.
David Alvaro (DA): Can you explain why it is so critical to engage with a specialist pharmacovigilance provider rather than trying to address those issues in-house or with a more generalist services provider?
Sally Amanuel (SA): At its core, pharmacovigilance focuses on safeguarding public health. At PrimeVigilance, our company mission is to bring expertise to deliver medicines that the world can trust, guided by a vision of a world with safer drugs. Everyone has family and friends who take medication, and we want to ensure we keep everyone safe by applying the highest level of good pharmacovigilance practices, both in terms of clinical safety and post-marketing surveillance. We record any adverse events that patients experience and perform assessments on causality and the seriousness of those events to help our clients monitor the benefit–risk profile of any drugs that are on the market.
Working with a specialist provider maximizes the depth of the insights you can access. At PrimeVigilance, we have been a trusted partner for over 300 clients — we have experienced most of the possible challenges and can bring best practices to the table to overcome them. We understand how regulators view certain gray areas and can advise and guide clients to achieve the optimal outcomes. Moreover, we offer bespoke services and collaborate as partners with our clients rather than simply executing transactional services and not adding much to the value chain.
DA: Can you share some of the history of PrimeVigilance, particularly how it emerged from Dr. Miroslav Rejanovic’s broader vision for the Ergomed Group?
SA: Dr. Reljanovic started out as an investigator in clinical trials, and through that work he developed a vision for how to accelerate drug development through more efficient clinical research focused on supporting investigative sites via a unique site management and study physician model to deliver quality results, whilst keeping the patient at the heart. To pursue that vision, he established the Ergomed CRO in 1997 focused on highly specialized clinical research and later in 2008, PrimeVigilance, a pharmacovigilance business. PrimeVigilance was originally founded with a focus on post-marketing business as a collaboration between Dr. Reljanovic and Dr. Elliot Brown, who was a former MHRA (Medicines and Healthcare products Regulatory Agency) regulator in the UK. This was well before the release of Good Pharmacovigilance Practice (GVP) guidance in 2012 that enables pharmacovigilance in the more robust capacity that is critical today, with a concerted effort to harmonize efforts through the establishment and implementation of good pharmacovigilance practices. Their shared vision for PrimeVigilance was to uphold the gold standard of pharmacovigilance from day one.
As a company, we developed very tight processes and applied them across the globe, even in jurisdictions where pharmacovigilance was still developing. We were one of two companies that volunteered for the first GVP inspection pilot scheme. The gold standard of quality has been embedded in our DNA from the start, but it has grown in leaps and bounds since 2008. Today, we offer almost a thousand FTEs (full-time employees), with boots on the ground in 26 countries across the globe and pharmacovigilance capabilities covering almost 160 countries.
From day one, our business model has centered on consultative SME (subject matter expert) input. Participating in over 400 health authority inspections over the years has allowed us to hone our processes and apply lessons learned from each of those inspections to support our clients. Perhaps the strongest testament to how successful those efforts have been is that we have never been issued a 483 or critical finding, which is unprecedented for a service provider that has been scrutinized so rigorously. At our last two annual FDA inspections, we had outcomes of no observations, and our client relayed the FDA’s feedback, which was essentially “The PrimeVigilance team really know their stuff.” That kind of accolade coming directly from a health authority demonstrates that we’ve been true to our founding vision and purpose.
DA: How is your business typically divided between relatively standard services and bespoke support specifically tailored to the needs of a client?
SA: We operate as a one-stop shop offering end-to-end pharmacovigilance and medical information capability for all things safety, soup to nuts. We can also provide standalone services, such as benefit–risk management, signal detection, aggregate reporting, literature services, etc., to meet very specialized or tailored needs.
Our client base is around 60% midsize pharma and biotech companies that don’t have mature pharmacovigilance departments and are more likely to require full-service outsourcing solutions from a boutique consultative specialist provider. All that we offer has developed over time into a model where clients can select the individual services they need.
However, when we can see the benefits of services that we develop for one client, particularly involving technology, we explore how they could be applied to other clients. Over time, we work to refine that technology solution and make it database agnostic and client agnostic so that we can share that value across all our clients.
PrimeVigilance is very clearly a specialist pharmacovigilance service provider, not a software company, but we are able to develop software to improve the efficiency and quality of our service offering and allow smaller or midsize companies to access the latest technology, which might otherwise have been unattainable for them on a basis of their volumes and return on investment. One such solution is our homegrown Automated Smart Processing PV (AsaPPV) Platform. AsaPPV originally developed for a client with a very specific problem: they were not located in Europe but needed to collect safety data and transfer it out of the EU. They were looking for case-intake solutions to anonymize and redact the data in the context of the new challenges associated with the introduction of the General Data Protection Regulation (GDPR). We did not see anything on the market that was adequate — in part because the available technology was developed for Big Pharma companies dealing with millions of cases per year rather than the thousands of cases relevant to midsized companies, so we built something bespoke. While such solutions are potentially a barrier to companies of a certain size, we were able to apply economies of scale and evolve that bespoke solution into an intake platform that provides a unique competitive advantage to our clients.
DA: In a broader sense, are there any technologies that have been particularly transformative within pharmacovigilance, or do you see any on the horizon that may have a significant impact?
SA: The pharma industry has historically lagged in adopting technology. However, within pharma, there is recognition that pharmacovigilance presents a particularly attractive opportunity for digitalization. You have a highly skilled workforce, including medical doctors and pharmacists, that must perform tasks that require a level of skill to execute effectively but can be quite repetitive. For years, companies have been trying to automate the administrative activities that pharmacovigilance professionals have been tasked with performing and thereby free them up to focus on higher-level critical-thinking activities.
In the past, that automation development has focused on rule-based technologies — lookups, workflow orchestration, and optical character recognition — to automate the administrative steps of case processing. Today, more companies, including PrimeVigilance, are venturing into more complex activities, applying natural language processing, natural language generation, machine learning, and other intelligent automation solutions to address activities further downstream that involve interpreting rather than just organizing the data.
For PrimeVigilance, technology drives growth by creating value. Our technology model is a mix of buying best-in-class, off-the-shelf solutions; utilizing some of that technology that is built into the systems we utilize from software and database providers; and using our own level of investment to add an additional layer above. We apply multiple technology solutions to the same process step, beginning with an orchestration-automation workflow and adding a layer of machine learning on top to pull out metrics, reporting, and customization, as well as the machine learning processing activity.
Machine learning is already well positioned for things like signaling that require pattern recognition or statistical modeling, but the next step, where human intervention is needed to be able to draw the correct conclusions, is still on the horizon. For example: machine learning and AI can identify an adverse event but not necessarily determine the seriousness of that adverse event without medical input. In addition, perhaps the biggest challenge facing unsupervised machine learning is demonstrating to regulators how those algorithms work, how that learning works, and how robust and accurate it is.
I think that those kinds of algorithms will develop over time, and it’s exciting to envision the ways that they will transform the discipline of pharmacovigilance, like enabling truly touchless case processing. Companies aim to integrate AI with databases that they do not own, which presents challenges, including data flow, algorithm transparency, and validation.
A further challenge is assembling sufficiently large data sets to train AI while navigating GDPR privacy constraints. The industry is accelerating its development efforts and gaining more regulatory acceptance, with health authorities forming committees to advise on best practices in AI development. The regulatory framework and interest are in place, setting the stage for further innovation.
DA: Could you describe how PrimeVigilance interacts with regulators and how you stay abreast of current and future regulatory changes?
SA: Our industry is inherently conservative and strictly regulated — for good reasons. On a daily basis, we engage with health authorities through hundreds to thousands of case submissions. Beyond this, PrimeVigilance has undergone over 400 audits and inspections by health authorities, in addition to client audits, averaging four to five per week. I have responsibility for ensuring that they have proper oversight of their vendors that are responsible for their pharmacovigilance activity.
Our clients, who are drug manufacturers, may have products that they’re licensing in, products that they’re selling, products that they’re acquiring, or new products that are about to launch, all of which require engagement with global health authorities around the world, for which they rely on our support. We assist with due diligence audits, harmonization of quality management systems (QMS), and standard operating procedures (SOPs) across products with varying requirements.
Many biotech companies are ripe for acquisition by a bigger pharma and need our support to review and streamline their preparations. Occasionally, acquired products come with corrective and preventive actions (CAPAs) and inspection outcomes that could threaten marketing authorizations. Our role includes resolving these inherited issues and interfacing with authorities, which informs us of their expectations and insights, which we can then feed back to support future clients.
Regarding technology, we’re currently in pioneering stages and are benefiting from industry associations and public consultations on draft guidance. Our multifaceted engagement with health authorities allows us to influence policy and stay informed on the trajectory of regulatory expectations.
DA: We’ve already touched on this, but are there any other differentiators for PrimeVigilance in the pharmacovigilance provider landscape that you can highlight?
SA: The pharmacovigilance sector spans between bespoke, specialist service providers like PrimeVigilance on one end and business process outsourcing (BPO) organizations that handle less complex tasks on the other. BPOs often rely on offshoring to reduce costs tend to have less global pharmacovigilance expertise. They emphasize process and efficiency, and those relationships tend to be more transactional than strategic.
Between these extremes are large contract research organizations (CROs) that bundle pharmacovigilance services into their clinical trial management offering, but not as a standalone specialty. Whilst they also engage in post-marketing pharmacovigilance, they are mainly focused on clinical safety. Additionally, there are smaller, local firms with in-depth local knowledge but limited geographic reach.
PrimeVigilance is uniquely positioned as a team of SMEs handling complex projects from clinical development through to post-marketing, with about 70% of our portfolio comprising innovative drugs where regulatory success is critical to project launch. We understand the drug development life cycle and have both medical and regulatory acumen to support companies making the transition from clinical to registration, and from registration to product launch. Although we compete with CROs and provide a similar geographical reach, we are seen as a boutique specialist able to add deeper value to the drug life cycle management. Our distinction has traditionally been delivering high-quality, complex services rather than competing on price. However, with advancements in AI and related technologies, we can now offer competitive pricing without compromising the specialized expertise we bring to the table. In my view, those who can provide the highest quality at an attractive price, utilizing the latest technologies, will lead the market because expertise is harder to cultivate than technology.
DA: With new products, technologies, and markets emerging, how does PrimeVigilance keep its team dynamic and maintain an appropriate diversity of expertise?
SA: We have always prioritized service excellence over size and cost. We have a critical mass of experts in the United States, Europe, and Japan, and we've recently expanded further into Asia. Leveraging technology like natural language processing and machine learning helps us transcend geographical and linguistic barriers, enabling us to offer centralized services that traditionally relied on local affiliates for pharmacovigilance support.
Centralization allows us to unify case intake, connecting data from various sources — from phone lines, medical information, literature, and case intake technologies — into a cohesive safety database. This ensures compliance and control across territories — a very elegant solution to an otherwise very complex and chaotic setup.
Our global network of pharmacovigilance experts reflects deep local knowledge and operational capabilities in over 160 countries, including places like Burkina Faso and Fiji where local pharmacovigilance expertise may be scarce. We are very proud to be able to say that the sun never sets on a case, because we can provide 24/7 case processing as work seamlessly transitions across time zones.
Team diversity is crucial for handling various product types. For example, biotechnologists and geneticists focus on gene therapies, while our medical doctors concentrate on their respective specializations and therapeutic areas. Our robust training academy ensures a continuous influx of skilled graduates, maintaining an optimal mix of junior and senior expertise, from case intake to quality control.
Regarding diversity, equity, and inclusion, we have long been ahead of the trend, with leadership distributed globally and equal opportunities offered regardless of global location. At the same time, we also have a wonderful mix of representation in terms of gender equality, with a significant proportion of women in leadership roles, reflecting the broader composition of our team. Our leadership's diversity in nationality, gender, sexual orientation, and experience contributes to a rich, innovative, and collaborative environment where we are able to challenge one another and be good sparring partners while embracing that diversity of thought.
DA: Can you elaborate on some of your branded solutions, like PV Consult and PV Transition?
SA: PVConsult emerged from recognizing that the challenges we encounter in leveraging technology are common across the industry. Our unique advantage is that we routinely engage with various client systems and technologies, which enables us to evaluate and test a multitude of products. This positions us to advise clients effectively on selecting the right technology stack tailored to their needs. Unlike pure technology firms, as SMEs in pharmacovigilance, we offer an unbiased and profound assessment of these technologies, considering their downstream impact.
PVConsult is designed to guide clients through technology transformation, from articulating roadmaps to selecting vendors, testing user requirements, and even validation. It’s a comprehensive partnership that assists organizations in achieving their technology goals within pharmacovigilance.
For mergers and acquisitions, we offer PVTransition and PVIntegrate. These services are tailored to the integration challenges that arise when companies merge. They provide bespoke consultancy, from gap analysis to process rewriting, ensuring a smooth transition and harmonization of pharmacovigilance systems.
PVTransition specializes in maintaining case processing while transitioning technology or service providers — like keeping a plane flying while rebuilding it or traversing a mobius strip that twists and turns while it continues. It requires a distinct skill set to manage ongoing operations during such a pivot. We have a team of PV Transition “ninjas” who are experienced in ensuring seamless switches without disruptions, while things are in flux, to ensure that nothing falls through the gaps.
The other solution we offer is PVExpert, which provides frontline support to address regulatory inquiries, share best practices, and advise on strategic or specific pharmacovigilance issues. It’s like having a “phone a friend” option for high-level guidance or to address targeted challenges, allowing customers to benefit from our extensive knowledge, expertise, and experience.
DA: Looking ahead, what do you see as the most significant challenges and opportunities for the pharmacovigilance sector and for PrimeVigilance?
SA: I’m very excited about the future. Outsourcing in pharmacovigilance is projected to grow at a very healthy rate until at least 2030. The sector is expanding, driven by an explosion in data. With rising chronic disease prevalence and disease complexity, as well as increased use of AI-enabled call centers, we anticipate the volume of adverse events reports to increase. The rise of AI with wearable technology will also lead to even greater surges in data, and innovations in social listening and diverse data collection avenues will amplify the sources for adverse event detection. This creates a promising landscape for service providers amid a trend toward greater outsourcing.
Regulations are also becoming more stringent, and more territories and geographies are developing their own regulatory requirements. China is a good example; they really started in 2019 and are now issuing more regulations each month than the FDA and the EMA combined.
With tightening regulations, increased disease complexity, and a data boom, the outlook for pharmacovigilance is optimistic.
The primary challenge lies in integrating technology, which also presents opportunities to enhance public health protection with more timely quality assessments and insights into signaling and benefit–risk analysis.
Lastly, the escalating costs of drug development, especially in the post-COVID era, are putting pressure on governments that have overspent on healthcare and need to balance their budgets and on drug companies to develop more affordable healthcare solutions, which affects service providers as margins tighten. This financial constraint reinforces the importance of technology to reduce costs without compromising quality, offering solutions and a reason for to be optimistic about the future of the industry and the pharmacovigilance sector.