HAROM combines specialist PV services, quality-led processes and connected technology to help organisations strengthen compliance, improve operational visibility and run safety activities more efficiently.
Control. Compliance. Efficiency.
Safety Vault v2.0
ICH E2B(R3) · CIOMS I · MedWatch 3500A
SignalIQ
Detect. Prioritise. Evaluate. Document.
Every action audited
Role-based access · MFA enforced · controlled workflows
8
Connected applications
Under one HAROM OnePV login, or alongside it
Multi-regulator
E2B(R3) submissions
EMA, FDA, MHRA, Health Canada, WHO PIDM
Audited
Every action
Audit trail, role-based access, MFA or one-time codes
Expert-led
Human-verified
PV professionals review every safety-critical step
Electronic submissions configured, routed and tracked for every authority through HAROM GatewayPRO.
EMA EudraVigilance
European Union
US FDA
ESG · FAERS
UK MHRA
United Kingdom
Health Canada
Canada Vigilance
WHO PIDM
International Drug Monitoring
Whether you are building a pharmacovigilance capability, extending operational support or reviewing your safety technology environment, HAROM provides the expertise, processes and systems to support your next stage.
Build a stronger foundation
HAROM helps organisations establish a complete pharmacovigilance system—from operating model and quality framework to training and technology—ensuring compliance and long-term sustainability.
Best suited for
Expertise when you need it
HAROM delivers operational, scientific and quality support across clinical and post-marketing pharmacovigilance, whether as focused services or through a comprehensive managed operating model.
Service areas include
Smarter safety operations
HAROM OnePV brings intake, case management, coding, submission, aggregate reporting and signal management under one sign-in — with every action audited.
Includes
Flexible ways to work with HAROM
Engagement models to match your goals and resources.
Full-Service Outsourcing
End-to-end PV support across your entire scope.
Functional Services
Specialist support for specific PV activities.
Dedicated Teams
Expert resources aligned to your model.
Technology-Enabled
PV services supported by OnePV platform.
Engage HAROM for a defined requirement, a complete workstream or an integrated PV operating model.
HAROM OnePV brings intake, case management, coding, submission, aggregate reporting and signal management under one sign-in — helping safety teams reduce system fragmentation, simplify access and gain clearer oversight across day-to-day pharmacovigilance activities.
One access point. Connected workflows. Every action audited.
One login
every OnePV application
Five applications under one login. Three connected applications in the same family.
One Workspace
Access critical PV applications from one environment.
Connected PV Workflows
Bring related safety activities, data and responsibilities closer together.
Clearer Oversight
Improve visibility across operational, safety and quality activities.
Built to Scale
Expand across products, markets, clients and users as requirements evolve.
Reduce technology fragmentation without compromising PV control.
A consolidated technology model can simplify user access, reduce system administration and support more efficient PV operations.
Configurable pharmacovigilance case management for controlled ICSR processing, regulatory reporting, quality review and operational oversight.
Controlled workflows. Complete traceability. Scalable safety operations.
Core safety database within HAROM OnePV
Run your own PV, run many clients behind one address, or take a dedicated instance. Every model is provisioned, governed and audited from one HAROM control office.
HAROM control office
Every client in every model, the CROs and their people, and who changed what.
CROs
3
3 active
Clients
14
6 direct · 7 CRO · 1 single
CRO people
12
11 active
MultiPV users
4
4 active · 19 sign-ins this week
Clients by model
How each client runs
Changes over the last 30 days
8 this week · 23 in 30 days · every change by a Super Admin, with a reason
An illustrative view of your workspace.
HAROM supports organisations at different stages of pharmacovigilance maturity — from establishing a first PV system to expanding global operations, adding specialist capacity or enabling a new service model.
Global medicines
brighter livesBuild and scale PV with greater control.
Typical needs
From innovation
to a safer tomorrowPut the right PV capability in place as your product advances.
Typical needs
Advancing clinical
research togetherStrengthen clinical safety or build a complete PV capability.
Typical needs
Extended capability
greater impactExpand capability without rebuilding your entire delivery model.
Typical needs
From first-time PV establishment to complex global delivery,
HAROM adapts the operating model to your organisation — not the other way around.
HAROM brings together PV establishment, specialist operations and connected technology within one accountable delivery model — helping organisations strengthen control, maintain quality and operate pharmacovigilance more efficiently.
From establishment to steady-state operations.
Experience built around real PV operations.
Purpose-built for pharmacovigilance workflows.
Use the capability you need, the way you need it.
Quality and compliance built into delivery.
Greater visibility and traceability at every stage.
People. Process. Technology. One accountable PV partner.
Whether you are establishing a pharmacovigilance system, expanding operational capacity or evaluating safety technology, HAROM can help define a practical model aligned to your requirements, compliance expectations and growth plans.
PV Establishment. Specialist Services. Connected Technology. One Partner.
