Pharmacovigilance Job Readiness Bootcamp: ICSR & MedDRA

Pharmacovigilance teams transform incoming safety information into structured, actionable knowledge, coordinating case processing, medical review, and reporting to protect patient safety.

Master pv roles and career entry points within the team, from case intake to medical review, ensuring day zero accuracy, data quality, and regulatory compliance with MedDRA coding.

Discover how case processing powers pharmacovigilance operations, from receiving reports through triage, processing with MedDRA coding and QC, to timely ICSR submission to regulators.

Master the end-to-end pharmacovigilance workflow for individual case safety reports by applying the five pillars—MedDRA coding, seriousness, expectedness, causality, and safety settings—through intake to medical review, including day-zero clock rules.

Clarify how adverse events, adverse drug reactions, serious adverse events, and CSRSR relate in pharmacovigilance, using a layered approach to determine causality, seriousness, and unexpectedness in trial safety.

Master how to distinguish seriousness, severity, and expectedness using ICH E2A criteria, assess the current RSI, and determine reporting timelines for safety cases.

Compare pre-marketing and post-marketing safety across five core dimensions—population, data source, seriousness, expectedness, and reporting—and apply a consistent ICSR triage using the IB for pre-marketing and the SMPC for post-marketing.

Trace spontaneous reports from the reporter to valid ICSRs, detailing intake criteria, four minimum elements, the day zero clock, and the expedited 15-day queue at the contact center.

Explore solicited sources like patient support programs, market research, and MSL contacts; apply a decision workflow to classify, code, and expedite safety reporting for AEs.

Learn to identify and triage literature, digital, and partner cases for the safety database, applying minimum ICSR criteria and avoiding common quality failures in pharmacovigilance.

Identify the case origin to determine the appropriate regulatory pathway and timelines, and code MedDRA to the lowest-level term to ensure accurate pharmacovigilance for clinical trials and post-marketing reports.

Identify the four minimum criteria for a valid ICSR: identifiable patient, identifiable reporter, suspect drug, and adverse event, before starting the regulatory clock. See how Day Zero governs regulatory timing.

Develop day zero assignment, clock start logic, and duplicate checks to protect regulatory timelines, and execute precise case intake, QC, and narrative.

Develop expertise in duplicate detection and case prioritization for pharmacovigilance intake and routing, using evidence maps to preserve traceability and make source-supported decisions.

Apply the four validity criteria to determine reportability, set day zero, perform deduplication, and craft a complete narrative with quality control to produce a regulatory-ready ICSR.

Master intake triage by applying five pillars: validity assessment, day zero assignment, duplicate detection, case record build, and narrative with QC to prevent regulatory clock failures and ensure pharmacovigilance reporting.

Transform raw, unstructured reports into regulator-ready ICSR case records by following a five-pillar workflow: validity criteria, day zero, duplicate check, case record fields, and narrative.

Learn to craft medically coherent case narratives that support medical reviews and regulatory submissions by applying the five pillars: patient context, suspect product, event, actions and outcomes, and source attribution.

Apply the five pillars of case quality in pharmacovigilance from day zero intake to final submission, covering day zero accuracy, validity, duplicates, narrative integrity, and MedDRA coding QC.

Master MedDRA's five-level hierarchy from LLT to SOC, learn accurate PT mapping, primary SOC selection, and quality checks essential for regulatory reporting and ICSR data entry.

Explore MedDRA architecture from verbatim to the preferred term, linking PTs to primary and secondary SOCs, and apply strict one concept, one PT rules for ICSR coding and signal detection.

Follow a structured workflow for product coding: identify every product, assign a role, map its indication to MedDRA PT, and ensure a complete per-drug record.

Develop MedDRA coding skills by verbatim-to-pt mapping from LLT to SOC, handling indication and concomitant logic, and applying quality checks to select the most specific PT.

Assessing seriousness with the ICH E2A criteria guides rapid case routing and regulatory scrutiny to protect patients. Build professional judgment through dual review, SOP compliance, and a robust audit trail.

Compare the coded event and verbatim against the applicable reference safety information, evaluating event concept, severity, specificity, and context to decide expectedness and listedness, with a documented rationale.

Assess causality accurately by applying structured evidence—time to onset, dechallenge, rechallenge—and ensure independent reporter and company assessments in the ICSR drive timely, compliant regulatory reporting.

Practice predicting escalation triggers in pharmacovigilance by recognizing serious or unlisted events, documenting the decision trail, and coordinating with the medical team via MedDRA cross-checks and dual-review.

Move fast with seven-day and fifteen-day rules, day zero awareness, and a rigorous audit trail. Protect patient safety and regulatory obligations by acting swiftly and compliantly.

Master expedited reporting in pharmacovigilance by applying seven- and fifteen-day timelines for ICSRs, guided by four minimum criteria, RSI, and day zero, with follow-up and E2B standards.

Master E2B case submission basics and audit trail thinking to maintain regulatory trust through day 0, 7-day, and 15-day clocks, mandatory fields, and immutable records.

Learn how a single ICSR, with precise MedDRA coding, feeds aggregate reports, enabling signal detection and benefit-risk analysis to inform regulatory decisions.

Explore PBRER, DSUR, and PATER to turn individual ICSR data into population-level safety intelligence for regulators such as the EMA, with data lockpoint and aggregate analysis guiding benefit risk decisions.

Learn the signal detection ecosystem from data entry to regulatory action. MedDRA coding and case processing quality determine whether signals emerge in downstream analysis and patient safety.

Learn beginner benefit-risk thinking in pharmacovigilance by describing risks, estimating frequency, assessing seriousness and reversibility, considering patient benefit, and identifying whether risk minimization is needed, with clean case data.