Local Pharmacovigilance Requirements, Managed
One versioned register of every country's PV requirements, kept current by your affiliates and connected to the work it governs.
The Challenge
Local rules change. Most trackers never hear about it.
Every market has its own rules for expedited cases, periodic reports, risk minimization, signals, clinical trial safety and the local PV system. Most companies track them in country workbooks and spreadsheets that drift out of date, are hard to verify, and sit apart from the trackers where deadlines are actually set. When a local rule changes, nothing downstream knows.
How It Works
One register for every country's requirements.
Country profiles
Each country or region gets a profile: health authority, accepted submission languages, working week and holiday calendar, the company region it sits in, and who covers it, whether a local safety office, a regional hub or a partner.
Structured, versioned rule records
Requirements are captured as structured fields, not free text: reporting timelines, clock-start (Day 0) definitions, accepted formats, recipients, submission method and responsibilities. Every record keeps its source guideline, version and date, so you can show exactly where a rule came from.
Maintained by the people who know them
Country safety office stakeholders and affiliates enter and maintain their own country's requirements, on a set review cycle. Orbit shows assessment coverage by functional area and flags overdue reviews, so you can see which countries are current and which need attention.
Rules that drive the work
Verified rules can drive automation in other Orbit trackers. When an aggregate safety report is scheduled, for example, Orbit proposes each country's submission activity with a calculated due date and records which rule version it came from. Each rule can be set to apply automatically, propose for confirmation, or stay reference-only.
Functional Areas
Requirements across the PV system.
- Aggregate safety reports (post-marketing periodic reports)
- Risk management and aRMMs
- Signal management and authority notification
- Case processing and expedited reporting
- Clinical trial safety: SUSARs, DSURs and urgent safety measures
- PV system and PSMF: local QPPV/LPPV and PSMF requirements
Getting started
Already keep your local requirements in workbooks? Import them into Orbit, then assign owners and review dates country by country.
Connected trackers
Local requirements feed the Orbit trackers where the work happens.
Aggregate Safety Reports
Harmonize the global PSR schedule and manage generation and submission across your portfolio
Risk Management Plans
Track global RMP documents, versions, and commitments
Signal Management
Manage signal detection activities and the Module IX assessment process
PV System Master File
Track and maintain the PSMF centrally, and manage local notifications and submissions
See Local Requirements in action.
Let us show you how Orbit keeps every country's PV requirements current and connected.
