Pharmacovigilance
Guides for drug safety monitoring in PIN — reporting adverse events, detecting signals, preparing regulatory submissions, generating PSURs, and managing risk plans.
Adverse Event Reporting
Capture, classify, and submit drug safety events
PIN's adverse event (AE) reporting module captures suspected drug reactions, unexpected outcomes, and serious adverse events (SAEs) directly from the clinical record. Reports are structured to ICH E2B(R3) standards and can be submitted to regulatory authorities or your institution's pharmacovigilance team.
Serious Adverse Events require immediate action Any SAE (fatal, life-threatening, hospitalising, or causing persistent disability) must be reported within 24 hours of becoming aware. Use the expedited SAE pathway described in Step 3 below — do not use the standard AE form.
1
Open the AE form from the patient record
Navigate to the patient's record and click Safety → Report Adverse Event. This pre-populates demographic fields and current medications from the registry, reducing manual entry.
2
Classify the event
Complete the event classification fields:
Suspect Drug *
The drug suspected of causing the reaction — select from the patient's current medication list or enter manually with dose and route
Event Description *
Free-text narrative and MedDRA preferred term — PIN surfaces MedDRA term suggestions as you type
Onset Date *
Date the adverse event began — or "unknown" with an estimated timeframe
Severity
Mild · Moderate · Severe · Life-threatening · Fatal — maps to CTCAE grade
Causality
WHO-UMC causality classification: Certain · Probable · Possible · Unlikely · Unclassified
Outcome
Recovered · Recovering · Not recovered · Fatal · Unknown
3
Flag as SAE if applicable and use expedited pathway
Tick This is a Serious Adverse Event if the event meets any SAE criterion: fatal, life-threatening, requires hospitalisation, results in persistent disability, or is a congenital anomaly. The form expands to include SAE-specific fields (hospitalisation dates, outcome at discharge). SAEs are routed directly to your institution's pharmacovigilance contact and flagged for regulatory submission within the required timeframe.
4
Submit the report
Click Submit Report. A PIN Case ID is assigned (e.g.
AE-2026-04821). The report is saved to the patient record, added to the pharmacovigilance database, and — if configured — forwarded to your institutional PV team. You will receive a submission confirmation email.5
Submit a follow-up report if new information emerges
If the patient's outcome changes or new causality information becomes available, open the original AE report and click Add Follow-up. Follow-up reports are linked to the original case by the PIN Case ID and tracked together through to closure.
| Severity | SAE? | Reporting deadline |
|---|---|---|
| Mild / Moderate | No | Within 15 calendar days (non-expedited) |
| Severe | Case-by-case | Within 15 calendar days unless life-threatening |
| Life-threatening / Fatal | Yes | Within 24 hours — expedited pathway |
Signal Detection Methods
Identify emerging drug safety signals across the network
PIN's signal detection module runs quantitative disproportionality analyses across the aggregated AE database to surface drug–event combinations that appear more frequently than expected. Signals are reviewed and triaged by the PIN pharmacovigilance team before being surfaced to members.
Active Signals
Drug–event pairs currently under investigation. Visible to all members under Safety → Signal Tracker. Each signal shows the disproportionality score, case count, and current review status.
PRR / ROR
Proportional Reporting Ratio and Reporting Odds Ratio — the two primary quantitative methods used by PIN's automated detection engine. A PRR ≥2 with ≥3 cases triggers a signal candidate for manual review.
Signal Alerts
Email notifications sent to members who prescribe the implicated drug when a new confirmed signal is raised. Configure your alert preferences under Settings → Notifications → Safety Alerts.
Signal Assessments
Clinical assessments prepared by the PIN PV team for confirmed signals — includes causality analysis, affected population characterisation, and interim risk mitigation recommendations.
Running a custom signal query
1
Navigate to Safety → Signal Detection → Custom Query
This tool lets you run an ad hoc disproportionality query for a specific drug or drug class against any MedDRA System Organ Class or preferred term.
2
Select drug and event term
Enter the suspect drug (generic name or ATC code) and the MedDRA preferred term you wish to query. Set a minimum case count threshold (default: 3) and a date range for the analysis window.
3
Review the output
The query returns the PRR, ROR, 95% CI, and case count. Results with a PRR ≥2 and lower CI bound >1 are highlighted as potential signals. You can export the output as a PDF for inclusion in a PSUR or safety report.
Custom queries require Research access The Signal Detection custom query tool is available to members with Research or Pharmacovigilance permission tier. Contact your institution's PIN administrator if you need access elevated.
Regulatory Submissions
Prepare and submit ICSRs and expedited reports
PIN can generate ICH E2B(R3)-compliant Individual Case Safety Reports (ICSRs) and route them to the appropriate regulatory authority — EMA EudraVigilance, FDA MedWatch, Health Canada, or your national competent authority — based on the patient's country of care.
1
Open the AE report you want to submit
Navigate to Safety → Adverse Event Reports and open the relevant case by PIN Case ID. Only submitted (not draft) AE reports can be escalated to regulatory submission.
2
Click "Submit to Regulator"
From the case detail view, click Submit to Regulator. PIN determines the appropriate authority based on the patient's country of care and the drug's marketing authorisation status. You can override the suggested authority if required.
3
Review the E2B(R3) preview
PIN generates a structured E2B(R3) XML preview. Review the mapped fields — particularly the MedDRA terms, causality assessment, and narrative — before submission. Click any field to edit it inline without returning to the original AE form.
4
Confirm sender details and submit
Verify the sender organisation, contact details, and local reference number (your institution's case number, if applicable). Click Confirm & Submit. PIN transmits the E2B file and returns a regulatory acknowledgement number which is stored on the case record.
| Authority | Submission route | Supported report types |
|---|---|---|
| EMA EudraVigilance | EVWEB / ESTRI Gateway | ICSRs, follow-ups, nullifications |
| FDA MedWatch | MedWatch 3500A (E2B) | ICSRs, expedited 15-day reports |
| Health Canada | MedEffect Canada portal | ICSRs, summary reports |
| TGA Australia | Blue Card / TGA portal | ICSRs |
| MHRA UK | Yellow Card scheme | ICSRs, follow-ups |
PIN submits on your behalf — your obligation remains PIN's regulatory submission tool facilitates transmission but does not transfer your legal reporting obligation. You remain responsible for verifying the accuracy of submitted data and meeting applicable deadlines under your jurisdiction's regulations.
PSUR Generation Guide
Build Periodic Safety Update Reports from registry data
A Periodic Safety Update Report (PSUR) — also called a Periodic Benefit-Risk Evaluation Report (PBRER) under ICH E2C(R2) — is a regulatory document summarising cumulative safety data for a drug over a defined period. PIN's PSUR generator assembles the data sections from the registry, leaving the clinical interpretation and benefit-risk evaluation for your medical writing team.
1
Navigate to Safety → PSUR → New Report
Click + New PSUR and enter the drug name (or ATC code) and the Data Lock Point (DLP) — the date up to which data will be included in this PSUR period.
2
Set the reporting period
Define the start and end dates for this PSUR period. PIN will automatically pull all AE reports, signal assessments, and registry outcome data within this window for the selected drug.
3
Review auto-populated data sections
PIN pre-fills the following ICH E2C(R2) sections from registry data:
Section 6
Estimated exposure — patient-years and treatment episode counts from the registry
Section 7
Data in summary tables — line listing of all ICSRs in the period, by seriousness and causality
Section 10
Signal and risk evaluation — active signals from the period with status and disposition
Section 16
Summary of safety concerns — changes to the known safety profile identified in the period
4
Export the draft for medical writing
Click Export Draft → DOCX to generate a structured Word document with all PIN-populated sections. Your medical writing team adds the benefit-risk narrative, executive summary, and any sections requiring clinical interpretation. PIN does not generate benefit-risk conclusions — those require qualified medical assessment.
5
Archive the completed PSUR
Once the final PSUR is approved internally, upload the completed document back to PIN under Safety → PSUR → Upload Final. This creates an audit trail linking the final submission to the underlying registry data that was used.
PSUR templates PIN provides PSUR shell templates pre-formatted to EMA and FDA expectations. Select your target authority when creating a new PSUR and the section headings and formatting will match the relevant guidance document.
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Risk Management Planning
Document and track risk minimisation measures
PIN's Risk Management Plan (RMP) module allows pharmaceutical partners and institutional PV leads to document identified risks, important potential risks, and missing information for each drug — and to track the risk minimisation activities (RMAs) associated with each safety concern.
1
Create or open an RMP record
Navigate to Safety → Risk Management Plans. Click + New RMP and select the drug. If an RMP already exists for this drug, click to open and add a new version — PIN maintains a full version history.
2
Define the safety concern inventory
Add each safety concern under its appropriate category:
Identified Risks
Established causal associations supported by evidence — e.g. opioid-induced respiratory depression
Potential Risks
Associations suggested by signals or biological plausibility but not yet confirmed — under active investigation
Missing Information
Gaps in the safety database — e.g. use in pregnancy, paediatric use, long-term outcomes beyond 24 months
3
Assign risk minimisation activities
For each safety concern, document the RMAs in place. PIN supports both routine and additional RMAs:
Routine RMAs
Product labelling updates, prescribing information, standard patient leaflet
Additional RMAs
Healthcare professional communications, patient alert cards, controlled access programmes, educational materials, REMS (US) or ARAS (EU)
4
Set review milestones
Each RMP record requires a next-review date. PIN will surface a reminder when the review date approaches and prompt you to either confirm the RMP remains current or create a new version with updates. Review dates typically align with PSUR Data Lock Points.
5
Link to active signals and PSUR periods
Use the Link button on any safety concern to connect it to an active signal in the Signal Tracker or to an open PSUR period. This creates a traceable thread from raw AE data through signal evaluation to RMP action — useful for regulatory inspections.
You're all set PIN's pharmacovigilance module covers the full safety lifecycle — from individual case capture through signal detection, regulatory submission, PSUR generation, and risk management documentation. Every step is audit-logged and linked to the underlying registry data.