The 9 Core Competencies of Pharmacovigilance

Ability to evaluate raw spontaneous or clinical trial adverse event reports and determine whether the four mandatory validity elements are satisfied: identifiable patient, identifiable reporter, suspect medicinal product, and adverse event.

Translating unstructured clinical narratives and doctor consultation notes into precise, compliant electronic E2B(R3) data fields without omissions or assumptions.

Correctly classifying adverse events as Serious vs. Non-Serious across the 6 standard criteria: Death, Life-Threatening, Hospitalization/Prolongation, Disability, Congenital Anomaly, or Important Medical Event (IME).

Navigating the 5-level MedDRA hierarchy from Lowest Level Term (LLT) to Preferred Term (PT) and System Organ Class (SOC) following official MSSO points-to-consider rules.

Evaluating the causal relationship between suspect drug administration and the adverse event considering temporal sequence, dechallenge, rechallenge, and confounding medical history.

Identifying underlying diseases, concomitant medications, and drug-drug interactions that explain or confound observed adverse events.

Mastery of regulatory submission clock calculation: Day 0 determination, 7-day fatal/life-threatening clinical trial deadlines, 15-day expedited post-marketing alerts, and periodic aggregate report schedules.

Composing structured, chronological, factual, and concise clinical narratives summarizing patient demographics, suspect therapy, adverse event timeline, treatment, and final outcome.

Understanding inspection readiness, audit trail preservation, query management, and quality control checks before case routing and lock.