Pharmacovigilance clarity, from complexity to confidence

A trusted partner across the entire pharmacovigilance system lifecycle

A reliable, effective pharmacovigilance system is more than a technical requirement — it's the foundation of patient trust and product success. Novavexa's pharmacovigilance technology specialists work as an extension of your team, guiding you through implementation, AI adoption, hosting and day-to-day operations across your PV safety systems — so you can navigate case processing, regulatory reporting and system compliance with confidence.

Strategic & technical capabilities

Services built around your safety platform, not ours

Novavexa's team guides clients from initial configuration through post-market operations — enabling you to navigate case processing, regulatory reporting and system compliance with precision.

01

Implementation & Modernization

Safety suite implementation, upgrades and configuration — delivered by consultants who've done it before, across leading PV safety systems.

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02

Hosting & Infrastructure

Secure, validated, AWS-based hosting for your safety platform, with the availability and compliance a GxP environment demands.

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03

Managed Services

Ongoing safety system support for both on-premise and Novavexa-hosted clients — configuration, reporting, access and more.

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Why Novavexa

Domain expertise, dependable delivery, no product to push

We combine deep pharmacovigilance domain knowledge with hands-on experience across PV safety systems. Because we don't build or sell a safety database of our own, our advice and our roadmap stay aligned with what's genuinely right for your organization.

PV Safety Systems AI Adoption in PV GxP-aligned Hosting

What sets us apart

  • A pure services model — our recommendations aren't shaped by a product agenda
  • One team across implementation, hosting and managed services
  • A quality-first approach, aligned to GxP and validation best practice
  • Global delivery across Canada, the US, Germany and India

Let's talk about your safety system

Tell us what you're working on — implementation, hosting, or better ongoing support — and we'll take it from there.

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Who we are

A dedicated pharmacovigilance services partner

Novavexa brings together life sciences domain expertise and deep technology know-how to support safety, regulatory and quality teams — without a product agenda getting in the way.

Domain expertise + delivery discipline

What makes Novavexa different

DE

Domain Expertise

Our consultants bring years of hands-on pharmacovigilance and drug safety technology experience, across implementation, migration and day-to-day operations.

DT

Deep Technology Know-How

We stay current on PV safety systems, on emerging AI capabilities in pharmacovigilance, and on the cloud infrastructure that keeps them running.

DP

Dedicated Partnership

We work as an extension of your team, committed to transparency and long-term relationships rather than one-off transactions.

Vision & Mission

Helping safety teams get more value from the systems they already run

Pharmacovigilance is often treated as a cost center. We see it differently: with the right implementation, the right hosting, and the right ongoing support, a safety system can run leaner, respond faster, and free your team to focus on patient safety rather than system upkeep.

Whether you're standing up a safety practice for the first time or looking to get more from an existing investment, our goal is the same — a stable, compliant, well-supported system, delivered by people who've done this before.

What guides us

  • Transparency, integrity and clear communication with every client
  • Long-term relationships over short-term transactions
  • A quality-first approach to every implementation and migration
  • Staying platform-agnostic so our advice serves you, not a product line
Unmatched expertise

A practice built specifically around pharmacovigilance technology

Our consultants, engineers and support specialists collaborate seamlessly to guide clients through complex safety-system challenges — from the earliest configuration decisions through long-term operations. It's the kind of focused, PV-specific experience that makes us a trusted partner for organizations seeking dependable delivery and long-term compliance.

Why partner with Novavexa

A closer look at how we work

We don't sell a safety database, so our recommendations are never shaped by a need to steer you toward our own product. You get advice based on what fits your organization.

Implementation, hosting and managed services sit under one roof, so there's no hand-off gap between the team that builds your system and the team that runs it.

Every engagement follows a validated, GxP-aligned methodology — from requirements through go-live and into ongoing support.

With teams across Canada, the United States, Germany and India, we support clients across time zones without losing continuity.

Want to know more about how we work?

We're happy to walk through our approach and introduce the team that would support your program.

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Strategic & technical capabilities

The direction and expertise clients count on for complex safety-system challenges

Our team guides clients from the earliest configuration decisions through post-market operations — enabling you to navigate case processing, regulatory reporting and system compliance with precision, no matter where you are in the lifecycle.

Strategic & technical capabilities

Seven ways we support your pharmacovigilance operation

Each engagement is built to support your objectives, while aligning with evolving global demands — delivered by one team across the full lifecycle. Select any service for details.

Implementation & Safety System Modernization

We deliver inspection-ready safety systems that streamline data, support oversight, and scale with compliance.

  • Vendor evaluation
  • Safety suite implementation (Fast Track)
  • Version upgrades & reconfiguration
  • Workflow & gateway design
  • Computer System Validation (CSV) and Assurance (CSA)

AI Adoption and Benefit Realization

A phased approach to adopting AI in PV — a shift in technology, processes and culture. We define benefits across four dimensions: Efficiency, Quality/Compliance, Speed and Strategic Value.

  • Foundation & readiness
  • Human-in-the-Loop (HITL) augmentation — “hallucination” and accuracy risk
  • Model drift
  • Measuring and improving FTE per case, cycle time and first-pass data quality score

PV Process Optimization and Training

We design and optimize PV processes, ensuring compliance with authorities and partners.

  • Safety system and processes remain in a validated state
  • Workflow redesign and optimization
  • Developing and delivering customized training programs

Hosting & Infrastructure

Secure, validated, AWS-based hosting built for the realities of a GxP environment.

  • Single- and multi-tenant hosting
  • Disaster recovery & business continuity
  • Encryption & access controls
  • Continuous monitoring & patch management

Managed Services & Operational Support

We handle the day-to-day so your internal team can stay focused on safety, not system upkeep.

  • Configuration management
  • E2B & regulatory reporting support
  • User access & administration
  • Case processing troubleshooting

Data Migration & Technology Enablement

Validated, risk-mitigated transfer of safety data, plus hands-on support selecting or upgrading your technology.

  • Cross-platform data migration
  • Technology assessments
  • Vendor-neutral selection support
  • Safety system upgrades

Compliance & Inspection Readiness

Practical solutions that keep your safety operations ahead of regulatory expectations.

  • Audits & gap assessments
  • Inspection readiness
  • CAPA support & root-cause analysis
  • Documentation & process alignment
Challenges we solve

Common pharmacovigilance obstacles — and how we address them

Fragmented Safety Systems

The Challenge. Many organizations run pharmacovigilance on disconnected or under-supported systems, leading to manual workarounds and compliance risk.

Our Solution. Novavexa unifies safety operations through structured implementation, configuration and system alignment that scales with your business.

Evolving Regulatory Reporting

The Challenge. E2B, aggregate reporting and regional submission requirements keep shifting, straining internal safety teams.

Our Solution. We keep your PV safety system configuration current, so regulatory reporting stays accurate as requirements evolve.

Hosting You Can't Fully Trust

The Challenge. Under-supported hosting leaves safety systems exposed to downtime, security gaps and audit findings.

Our Solution. Novavexa provides validated, AWS-based hosting with the availability, security and disaster recovery a GxP environment demands.

Managed Services That Don't Scale

The Challenge. Growing case volumes and license partner requirements can outpace internal support capacity.

Our Solution. Our managed services team absorbs day-to-day configuration, access and reporting work as your volumes grow.

Data Migration Risk

The Challenge. Moving case data between safety platforms risks data loss, validation gaps and audit exposure.

Our Solution. Our structured migration methodology ensures a validated, risk-mitigated transfer of safety data between systems.

Adopting AI Without Losing Control

The Challenge. AI in PV brings accuracy and “hallucination” risk, model drift, and benefits that are hard to measure.

Our Solution. Novavexa guides a phased adoption with human-in-the-loop controls and clear metrics — FTE per case, cycle time and first-pass data quality.

A closer look: hosting

A secure home for your safety platform

We host safety systems on AWS with the availability, security and compliance a GxP environment requires — single-tenant or multi-tenant, with disaster recovery built in.

  • Scalable, cloud-based infrastructure
  • Encryption for data at rest and in transit
  • Disaster recovery with configurable recovery targets
  • Continuous monitoring and patch management

Built for regulated environments

Our hosting approach is designed around the realities of pharmacovigilance: validated environments, controlled access, and infrastructure that stands up to health authority scrutiny.

A closer look: managed services

Support that keeps your system — and your team — running smoothly

Whether your safety system runs on our infrastructure or your own, our managed services team handles the day-to-day so your internal team can stay focused on safety, not system upkeep.

  • Configuration management and workflow support
  • Regulatory reporting support
  • User access and administration
  • Ongoing troubleshooting and case processing support

For on-premise and hosted clients alike

You don't need to be hosted with us to get our managed services — we support safety systems wherever they live.

PV Safety Systems

Hands-on expertise across the PV safety systems you already use

Implementation & Upgrades

Implementation, version upgrades and reconfiguration for your PV safety system, delivered on a validated, GxP-aligned methodology.

Configuration & Migration

Configuration management, workflow and gateway design, and validated data migration between PV safety systems.

Operations & Managed Services

Day-two operations, reporting support and user administration for on-premise and Novavexa-hosted PV safety systems.

Not sure which service fits your situation?

Tell us where you are today and we'll recommend a starting point.

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Join us

Careers at Novavexa

We are always looking for exceptional talent. If you think you'd be a good fit, please fill out the form below and get in touch.

Apply now

Tell us a little about yourself and where you'd fit at Novavexa — consulting, engineering, hosting or managed services. We review every application personally.

Don't see the right role listed?

We're always happy to hear from experienced pharmacovigilance and technology professionals. Submit the form above and we'll keep you in mind for what's next.

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Let's talk

Get in touch with Novavexa

Whether you need an implementation partner, a hosting home, or better managed services for your safety system, we'd like to hear from you.

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Reach us directly

Global coverage

With teams across four countries, we support clients across time zones for both project work and ongoing managed services.

Our offices

Where we work from

CA

Canada

Toronto — Client services & corporate office

US

United States

Client services & program management

DE

Germany

European client services

IN

India

Delivery, configuration & managed services