PV system architecture and process map
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
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System live
PSMF System Map
StatusSystem live
Our craft
Built around real pharmacovigilance practice.
Service Detail
Build the PV operating system behind compliance.
PharmaRevix builds and maintains pharmacovigilance systems, including PSMF authoring, safety database setup, SDEAs, data migration, and ongoing stewardship.
You are launching a product and need a PV system
Your PSMF needs creation or remediation
You need SDEAs and vendor interfaces structured
You are moving from one safety database to another
Deliverables
Practical outputs your team can use immediately.
PSMF authoring and maintenance package
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
Safety database setup checklist
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
SDEA template and negotiation tracker
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
Migration and reconciliation plan
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
Routine system health dashboard
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
Workflow
A clear sequence from assessment to handoff.
01
Assess
Assess current or planned PV operating model
02
Plan
Build SOPs, PSMF, database, and vendor interfaces
03
Execute
Test intake, triage, reporting, and escalation workflows
04
Maintain
Maintain the system with periodic review and updates
Proof Package
Every engagement leaves an evidence trail.
The work is designed for real review: authority questions, partner due diligence, quality audits, and internal leadership updates.
PSMFSDEASenior-led
PSMF authoring and ongoing maintenance
Captured with owners, assumptions, decision rationale, and next actions so the work can continue smoothly.
Safety database setup, configuration, and administration
Captured with owners, assumptions, decision rationale, and next actions so the work can continue smoothly.
Safety Data Exchange Agreement drafting and negotiation
Captured with owners, assumptions, decision rationale, and next actions so the work can continue smoothly.
Data migration and system handover support
Captured with owners, assumptions, decision rationale, and next actions so the work can continue smoothly.
Related Services
Connect this work with adjacent regulatory and safety needs.
QPPV & Local Representative Services
PharmaRevix provides EU and UK QPPV, Deputy QPPV, Local Safety Officer, Contact Person, and local representative support where required by national legislation.
Explore serviceCase Processing & Submission
PharmaRevix supports ICSR receipt, triage, processing, narrative authoring, medical and quality review, and timely submissions to authorities and partners.
Explore serviceQMS & GAP Analysis
PharmaRevix develops SOPs, performs GAP analysis, supports internal audits, and prepares teams for mock inspection across pharmacovigilance and regulatory operations.
Explore serviceFAQ
Common questions about PV System Setup & Maintenance.
Short answers for teams deciding whether this is the right next step.
Ask us anythingPV system setup builds the operating model behind safety compliance, including PSMF authoring, safety database setup, SDEAs, data migration, and ongoing stewardship.
Yes. PharmaRevix can scope this as a standalone workstream or connect it with adjacent regulatory affairs, pharmacovigilance, QMS, and submission activities.
Yes. PharmaRevix can scope this as a standalone workstream or connect it with adjacent regulatory affairs, pharmacovigilance, QMS, and submission activities.
Free 30-minute consultation
Need pv system setup & maintenance support?
Talk with PharmaRevix about scope, timelines, and the cleanest next step for your market or safety obligation.