9.1
64
ICSR Case Management
Manage adverse event case intake, processing, QC, medical review, reporting, follow-up, and closure.
View toolkitStage 9
Post-market pharmacovigilance system
Operational systems for managing post-market safety obligations, evidence, oversight and inspection readiness.
What this stage covers
ICSRs, literature, signals, risk management, aggregate reporting, PSMF, affiliates, vendors, training, KPIs, and document control.
How it helps your team: Connect day-to-day safety operations with visible ownership, evidence, and inspection readiness.
14 toolkits
Choose the operational area you need
9.2
54
Literature Surveillance & Review
Manage literature search, screening, medical review, reportability, and evidence of surveillance.
View toolkit9.3
64
Signal Management
Detect, validate, prioritise, assess, escalate, document, and close safety signals.
View toolkit9.4
64
Risk Management / RMP
Manage safety concerns, RMP commitments, risk minimisation, effectiveness, and updates.
View toolkit9.5
65
Aggregate Reporting
Manage PSUR/PBRER/DSUR planning, data contributions, QC, submission, and tracking.
View toolkit9.6
64
PSMF Management
Maintain the PSMF, annexes, updates, QC, and evidence of PV system control.
View toolkit9.7
54
Local / Affiliate PV
Manage local PV obligations, affiliate responsibilities, local submissions, and oversight.
View toolkit9.8
55
PV Audit, Deviation & CAPA
Manage PV audit schedule, findings, deviations, CAPAs, effectiveness, and inspection readiness.
View toolkit9.9
54
PV KPI & Performance Management
Monitor PV performance, quality, governance, escalation, and continuous improvement.
View toolkit9.10
54
PV Regulatory Intelligence
Monitor PV regulatory changes, assess impact, track implementation, and document governance.
View toolkit9.11
43
PV Roles & Responsibilities
Define PV responsibilities, ownership, delegation, local/global roles, and vendor responsibilities.
View toolkit9.12
54
PV Vendor Qualification & Oversight
Qualify, manage, monitor, audit, and requalify PV vendors.
View toolkit9.13
44
PV Training & Competency
Manage PV onboarding, role-based training, retraining, compliance, and competency evidence.
View toolkit9.14
53
PV Document Control
Control PV SOPs, templates, trackers, logs, review, approval, change, and archiving.
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