Pharmacovigilance Product Specialist

1 semana atrás


Salvador, Brasil Bebeeregulatory Tempo inteiro

As a key member of our team, you will serve as a strategic liaison between business users, regulatory teams and IT for pharmacovigilance systems and workflows.This role combines strong product ownership responsibilities with deep domain expertise in pharmacovigilance, regulatory compliance and technology.The ideal candidate will oversee end-to-end product roadmaps to ensure alignment with business needs and drive platform upgrades, integrations and compliance.Owns and manages PV product roadmap.Oversees platform maintenance, rebuilding and tech stack upgrades.Stays updated on the latest pharmacovigilance and product technology trends.Cross-functional collaboration with business, infrastructure and leadership teams is crucial for product releases, downtime, incidents and upgrades.You will serve as a key liaison across regulatory, clinical operations, QA and IT functions.Ensuring safety system integrations and compliance with global standards is essential.Supports signal detection and reporting in line with FDA, EMA, MHRA, GXP and CFR standards.Collaborates with QA for system quality checks, validation and signal monitoring.Gathers and analyzes requirements for PV systems and workflows.Documents processes, data flows and system functionalities related to adverse event reporting.Provides user training, support and knowledge sharing.Your focus will be on driving business outcomes through effective pharmacovigilance system design and implementation.We are seeking an experienced professional who can bring their expertise to this critical role.



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