?Four minimum criteria for a valid ICSR (identifiable patient/reporter, suspect product, event) ?Multi-channel intake protocols and CRM-based logging ?Causality assessment methods (WHO-UMC, Naranjo) and seriousness/expectedness grading ?AE narrative writing practice from raw case notes

?Passive surveillance (spontaneous reports, case series) vs active surveillance (sentinel sites, registries) ?Introductory disproportionality concepts (PRR/ROR) for signal detection Signal validation, prioritisation and management workflow in industry practice

?ICH E2C(R2) PBRER/PSUR structure walk-through; DSUR basics ?Data aggregation, tabulation and simple descriptive statistics for safety data Benefit-risk narrative writing practice using a template

?Inquiry classification, response timelines and channel-appropriate handling ?Literature search strategy and evidence-hierarchy based critical evaluation ?SRD/FAQ authoring standards and inquiry database/tracking practice

?PQC intake, classification and triage ?Cross-functional coordination workflow with QA/RA teams ?Documentation and closure of a PQC case

?Comparative overview of FDA, CDSCO, EMA structures relevant to MI/PV ?Schedule Y, GCP obligations and pharmacovigilance in clinical trials Regulatory documentation and inspection-readiness checklist practice

?Narrative-writing conventions for AE/PQC cases ?Tone, style and compliance considerations in regulated medical writing ?Structured practice: drafting a custom HCP inquiry response

?Multi-channel communication practice (phone/email/chat) and handling difficult conversations ?Documentation discipline, attention to detail and cross-functional teamwork simulation