Pick The Right PV Technology With Help From A Safety Data Management Expert

A conversation with Vikalp Khare, head of U.S. GPV safety data management, Otsuka

In pharmacovigilance (PV), technology decisions can define the balance between compliance, scalability, and patient safety — and few understand that interplay better than Vikalp Khare. In this conversation, he challenges common assumptions that bigger pharmaceutical companies always have better systems, emphasizing instead that every trial deserves a fresh, risk-based evaluation. From leveraging past lessons to balancing innovation with regulatory rigor, he shares how smart governance should inform PV technology choices. His perspective offers a practical road map for clinical professionals seeking to build inspection-ready ecosystems that evolve with science and regulation alike.

One might assume that a Big Pharma’s technology suite is well established and ingrained, as opposed to that of a small biotech researching a vendor for the first time. Is that always the case? Or do you assess the PV needs of each trial, regardless of company size or experience, anew?

Vikalp: That’s a very common assumption and one I’ve seen challenged repeatedly in my own experience leading global safety data management functions.

It’s true that large pharmaceutical organizations typically have well-established pharmacovigilance ecosystems consisting of validated global safety databases, standardized configurations, integrations with signal detection tools, regulatory gateways, analytics platforms, and structured governance and maintenance models. However, being mature does not always mean being aligned to evolving new requirements.

Each new study, region, or product can introduce complexity — whether it’s a novel therapy, hybrid trial design, decentralized data sources, evolving FDA/EMA/PMDA expectations, or increasing automation through AI. Legacy configurations, historical customizations, and global standardization are frequently challenged by thoughtful recalibration to remain compliant, scalable, and inspection-ready.

Interestingly, I’ve also seen smaller organizations approach PV technology with a clean slate. While they may lack infrastructure initially, they often benefit from agility — being able to architect streamlined, modern solutions without historical constraints. In some cases, they can implement forward-looking, automation-driven models faster than larger enterprises burdened by legacy systems.

In my role overseeing global safety systems, I do not assume that an existing technology suite is automatically sufficient — nor that a smaller company necessarily needs a simplistic setup. Every trial and every portfolio deserves a fresh, risk-based assessment aligned to patient safety, compliance, and operational efficiency.

PV technology should not be defined by company size; it should be defined by responsibility. And that responsibility always begins with ensuring the right system, configuration, and governance model for the specific program at hand.

There are a few big players in PV technology. What’s your approach — going with the trusted few, exploring newcomers, or something else?

Yes, there are a few well-established players in the PV technology space. I’ve worked extensively with these enterprise platforms. They bring maturity, regulatory credibility, audit history, global support models, and proven scalability.

However, my approach is not simply to default to the trusted few. I also do not chase new entrants purely for innovation appeal. I suggest taking a structured, risk-based, and future-focused view. Assessing true requirements is critical:

• Regulatory complexity (FDA, EMA, PMDA, Health Canada, etc.)
• Portfolio size and growth trajectory
• Integration landscape (intake setup, signal detection, analytics, regulatory gateways, clinical systems)
• Inspection readiness and validation rigor
• Long-term total cost of ownership

If a leading enterprise platform aligns with these needs, offers strong life cycle support, and integrates well within the broader ecosystem, that stability is valuable. But I also continually evaluate emerging solutions, particularly in areas such as AI-driven case processing, automation, advanced analytics, and workflow optimization. Innovation in PV is accelerating, and we have a responsibility not to be complacent.

Based on my experience, vendor/system selection is rarely about brand reputation alone. It’s about governance maturity, configuration flexibility, transparency of the road map, responsiveness during regulatory changes, and partnership mindset. Sometimes that means consolidating around a trusted enterprise system for core safety processing, while strategically integrating newer, specialized technologies to drive efficiency and automation. So, my approach is neither conservative nor experimental; it’s balanced and intentional. I prioritize regulatory robustness and patient safety first, but I remain open to innovation that measurably enhances compliance, efficiency, and data intelligence.

To support your search, what historical knowledge do you leverage from within a company?

Technology selection in PV should not be driven purely by market positioning or feature comparison. It should be driven by what has worked, what has failed, and where risk truly lies. A company’s historical knowledge is one of its most valuable strategic assets. When supporting a PV technology search, my starting points are to leverage:

• Upgrade and validation experience – Having led major global upgrades, I review lessons learned — what created complexity, where integrations struggled, and how validation efforts scaled. Those insights prevent repeating past inefficiencies.
• Global user feedback – Case processors, safety physicians, and signal teams often highlight workflow bottlenecks and manual workarounds. Their operational insight is essential.
• Integration landscape history – In pharma, safety systems sit within a broader ecosystem. Understanding prior integration challenges with clinical systems, regulatory gateways, or analytics platforms heavily influences future architecture decisions.
• Vendor performance track record – Past responsiveness during regulatory changes, support quality during critical incidents, and partnership behavior matter as much as functionality.
• Inspection and audit history – Regulatory observations and health authority queries provide real-world evidence of where systems or processes have been tested. That insight directly shapes requirement definition and risk mitigation.

Historical knowledge provides the context that allows innovation to be implemented responsibly, compliantly, and sustainably.

What aspects of a trial might prompt you to reassess PV technology, rather than rely on what’s been used in other trials?

In PV, assuming what worked before will work again can introduce risk. The moment a trial introduces new complexity, we pause to ensure our systems are still fit for purpose. In my experience overseeing global safety systems, several trial-specific factors can be a trigger to reassess the PV technology setup rather than simply relying on prior setups or configurations:

• Novel modality or complex mechanism of action: Advanced therapies, combination products, auxiliary medicinal products, or first-in-class molecules often introduce unique safety profiles. If the event patterns, data structures, or risk management requirements differ significantly, system configuration and signal workflows may need adjustment.
• Geographic expansion and regulatory footprint: A trial spanning multiple regions — particularly including Japan (PMDA), EU, or emerging markets — can introduce new reporting formats, timelines, and gateway requirements. That may necessitate configuration changes, new integrations, or additional compliance safeguards. Data privacy and regulatory restrictions for global dissemination of safety information are crucial factors.
• Trial design complexity: Adaptive trials, decentralized models, real-world data components, or hybrid study designs can significantly impact data flow and reconciliation processes. Integration architecture and case intake workflows need to be reassessed in case the data sources expand beyond traditional EDC inputs.
• Volume and scalability considerations: Large global studies or high-enrollment programs may stress case processing capacity, reporting timelines, and performance thresholds. In such cases, automation, workflow optimization, or AI-enabled triage tools may need to be introduced. Having a single source of truth for safety information can also be reassessed.
• Increased scrutiny and portfolio life cycle stage: Programs in sensitive therapeutic areas or with known class risks may require enhanced signal detection or more robust quality controls for ensuring a medicinal product safety profile. Moving from early-phase development into late-phase or post-marketing commitments changes the reporting landscape entirely. The system must support scalability, aggregate reporting, and global inspection readiness.

From my perspective, reassessment is not about reinventing the system for every trial — it’s about applying a structured, risk-based lens. Ultimately, PV technology should be dynamic enough to adapt to scientific and regulatory evolution.

At what point in the planning process is it preferable to begin this search?

The optimal time to begin assessing or searching for PV technology is earlier than most organizations initially expect.

As soon as there is reasonable clarity on the trial’s design, geographic footprint, and development strategy, it becomes possible to evaluate whether the existing PV ecosystem is fit for purpose. In practice, I recommend initiating this assessment when:

• the clinical development plan is being finalized
• regions and anticipated health authority interactions are known
• data sources and integrations (EDC, labs, devices, real-world data) are being defined.

Starting early allows sufficient time to perform risk-based assessments, evaluate configuration needs, engage quality and validation partners, and avoid reactive decisions driven by study timelines or regulatory deadlines. Waiting until a trial is active often forces teams to compromise using workarounds, rushed validations, or manual processes that increase both compliance risk and operational burden.

That said, this doesn’t always mean launching a full vendor search. Often, it’s an early fit gap assessment of the existing technology landscape. If gaps are identified, there is still time to course-correct thoughtfully. In pharmacovigilance, proactive planning is a safeguard. Beginning the assessment early ensures that technology decisions support the trials, protect patients, and withstand regulatory scrutiny.

What are the non-negotiables during a PV tech search, whether that means system integration, access models, validation, and/or data governance?

Having led global safety data management teams over the years, my non-negotiables center on three principles: patient safety, regulatory defensibility, and sustainable scalability. Key non-negotiables are:

• Regulatory compliance and inspection readiness: The system must demonstrably support global regulatory requirements, including FDA, EMA, PMDA, Health Canada, and beyond. That includes audit trails, reporting timeliness, data traceability, and clear documentation.
• Robust validation framework: Validation rigor is non-negotiable. The vendor must support a defensible validation approach aligned with current regulatory expectations. Clear documentation, test traceability, change management controls, and life cycle governance must be pre-built into the platform.
• Integration capability and scalability: In a global PV ecosystem, safety systems do not operate in isolation. Seamless integration with clinical systems, signal detection tools, regulatory gateways, analytics platforms, and data warehouses is critical.
• Data governance and security: Role-based access control, segregation of duties, encryption standards, and global data privacy compliance (including cross-border data transfer considerations) are mandatory.
• Configuration flexibility without excessive customization: The platform must allow standardized global configuration while supporting regional nuances. Heavy customization creates long-term technical debt and validation burden. I look for structured flexibility, not uncontrolled modification.
• Performance, scalability, and automation readiness: As portfolios grow and case volumes increase, the system must scale without compromising performance. Additionally, readiness to support automation and AI-enabled workflows is increasingly essential to future-proof the ecosystem.

Innovation is important and so are the efficiency gains. However, the solution should not compromise governance, compliance, or long-term resilience.

And how do those choices affect case quality, regulatory compliance, and scalability?

The choices we make during a PV technology search directly influence three outcomes: case quality, regulatory compliance, and long-term scalability.

1. Impact on Case Quality

When the underlying technology is well configured and governed, case processors can focus on medical assessment rather than navigating system inefficiencies. Poor system choices, on the other hand, create workarounds — and workarounds inevitably increase risk of error.

2. Impact on Regulatory Compliance

Compliance is not just about submitting reports on time — it’s about traceability, defensibility, and audit readiness. In my experience managing global systems, even small configuration misalignments can cascade into compliance risk. Technology decisions must therefore support regulatory requirements by design, not through manual oversight.

3. Impact on Scalability

As development programs expand globally or transition from clinical to post-marketing, case volumes and complexity increase. If scalability is not considered up front, organizations often face costly re-platforming or extensive remediation later.

Ultimately, technology decisions in pharmacovigilance are not IT decisions — they are patient safety decisions. When systems are chosen and implemented thoughtfully, they elevate case quality, strengthen compliance posture, and allow the organization to grow confidently. When they are not, the operational and regulatory consequences surface quickly. That is why I view PV technology strategy as a core governance responsibility.

About The Author:

Vikalp Khare is a technology leader in global pharmacovigilance and safety data management, with extensive expertise in Oracle Argus Safety Suite, large-scale data migration, and analytics. He oversees compliant and efficient safety operations across international markets, bridging technology and pharmacovigilance to build intelligent, scalable systems that support patient safety and regulatory requirements.