Regulatory, Safety, Devices, Market Access, and Public-Facing Work
Pharmacovigilance and safety writing
Case narrative
Construct a chronological, clinically coherent account from verified case data. Include necessary demographics, exposure, event, relevant history, tests, treatment, outcome, and assessment according to the applicable context. Reconcile discrepancies rather than smoothing them into a story. Minimize unnecessary identifying detail.
Aggregate and periodic report
Define period, product, exposure, data sources, signals, risks, and changes since the prior report. Integrate rather than list. Track recurring text, changed evidence, and downstream risk-management implications.
Dominant risks
Privacy loss, coding mismatch, inconsistent dates, incomplete follow-up, unsupported causality, missed change from prior cycle, and weak reconciliation across safety systems and narrative.