Long-term PV partnerships, not just case counts.
Anonymised engagements from HAROM's current portfolio: complete pharmacovigilance systems established, operated and independently audited for pharmaceutical organisations and CROs in India and around the world.
Establishment · Operations · Technology
Anonymised by agreement
Client identities withheld
Six organisations. One accountable PV partner.
Open an engagement to see the organisation's profile, what HAROM delivers and what it demonstrates. Organisation profiles use public information; engagement facts come from HAROM's project records.
Assessed on three things, not case volume: longevity, ownership and evidence.
Longevity
Key pharmaceutical relationships extending around eight to ten years.
PV system ownership
Complete PV systems established, not isolated transactional support.
Operational case management
Ongoing ICSR intake, processing, quality control, medical review and lifecycle activities.
Global and multi-client capability
A client moved from local PV to a global model covering about 45 countries; a CRO runs five MAHs from one address.
Independent audit evidence
Client vendor audits have evaluated ICSR operations, QMS, the safety database, medical review and data-integrity controls.
Quality governance
SOP and work-instruction framework, training and competency, QC, medical review, deviations and CAPA, change control and audit readiness.
Audited by the clients themselves.
Long-standing pharmaceutical clients have audited HAROM as a PV vendor, on the actual systems and processes HAROM runs for them.
2026 client vendor audit
Scope
ICSR processing, serious case assessment, safety database, QMS, signal management, training, deviation and CAPA, ALCOA+, 21 CFR Part 11 controls, backup and disaster recovery, audit-trail review.
Outcome
No major or critical findings; no formal audit findings recorded. The system was described as well structured and operational.
Long-standing client PV audit
Scope
ICSR processing and management, serious and non-serious adverse-event workflows, medical review, safety database, QMS, reconciliation, training, business continuity.
Outcome
The ICSR processing, management and reporting system was found robust and most processes well managed. No critical finding. Improvement observations were taken into HAROM's continuing quality-improvement framework.
Current volume is not the ceiling.
Today's portfolios are mostly lower-volume post-marketing programmes. For higher volumes HAROM scales through dedicated, role-separated delivery pods, each with project leadership, backup capacity, qualified training, quality KPIs and a phased ramp-up, under the same controls.
- Standardised SOPs and work instructions
- Dedicated project teams with role segregation
- Independent quality review and medical review
- Training and competency qualification
- Backlog and capacity monitoring
- Deviation and CAPA, business continuity, management oversight
One delivery pod
- 1Triage
- 2Data entry
- 3Independent QC
- 4Medical review
- 5Final review
Pods are added per programme; every pod runs the same procedures and the same quality gates.
Next step
Want a reference conversation?
Under agreement we can arrange a conversation with a long-standing client. Tell us your products, markets and volumes and we will propose the engagement that fits.