Service 04 / 06
Pharmacovigilance
Compliant safety reporting, from case intake to aggregate reports.
Overview
A complete drug safety function covering clinical trial and post-marketing settings. Cases are received, triaged, processed and reported within regulatory clocks, with a safety database and quality system built to withstand inspection.
- Case intake and triage within regulatory clocks
- Expedited regulatory reporting within clock
- DSUR, PSUR/PBRER and aggregate reporting
Capabilities
What this covers.
Each capability can be contracted on its own or as part of the full service line.
- 01
Case Processing & ICSR Management
Intake, triage, data entry, medical review and quality control of individual case safety reports, with MedDRA and WHO-DD coding applied consistently across the programme.
- 02
Expedited Reporting
SUSAR and expedited case submissions to DRAP, ethics committees and investigators within applicable timelines, with full submission tracking.
- 03
Aggregate Safety Reports
Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports and ad-hoc aggregate analyses authored by medical writers working alongside the safety physicians.
- 04
Signal Detection & Risk Management
Routine signal detection activity, benefit-risk assessment, and support for risk management plan development and maintenance.
- 05
Safety Database & Systems
Validated safety database configuration and maintenance, with audit trails and reconciliation against the clinical database at defined intervals.
- 06
PV System Master File & Audit Readiness
SOP development, PSMF maintenance, staff training records and inspection preparation, so the safety function is defensible at any point.
Deliverables
What you receive.
Concrete artefacts on an agreed schedule — so progress is verifiable rather than asserted.
- Safety management plan
- Processed and quality-controlled ICSRs
- Expedited report submissions and acknowledgements
- DSUR / PSUR / PBRER documents
- Signal detection reports
- Clinical–safety database reconciliation records
Related services
Often engaged alongside this.
Next step
Scope a pharmacovigilance engagement.
Share your protocol synopsis and target timeline. We come back with scope, assumptions and an indicative budget.