(Agile OR Scrum* OR "project management" OR Kanban OR FDD OR DSDM OR RUP OR TDD OR ATDD OR "software development life cycle" OR SDLC) AND integrat* AND (requirement* OR "user stories" OR "use cases" OR Visio OR artifacts OR template*) AND (Pharmacovigilance OR “PV” OR “drug safety” OR “Adverse event” OR SAE OR ADR* OR “AE” OR clinical OR ICSR OR MedDRA OR SUSAR OR PSUR OR DSUR OR PBRER OR QPPV) AND (“business analyst” OR “BA” OR “BSA” OR “business systems analyst” OR “business system analyst” OR “systems analyst” OR “business process”) AND (regulat* OR guideline* OR compliance OR Polic*)
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