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Senior adverse event reporting specialist

Rio de Janeiro (RJ)
beBeeProductivity
Eventos
Anunciada dia 3 outubro
Descrição

Pharmacovigilance Product Analyst RoleThe Pharmacovigilance Product Analyst serves as a strategic liaison between business users, regulatory teams, and IT to ensure pharmacovigilance systems and workflows are accurate, compliant, and efficient for adverse event reporting.This role combines product ownership responsibilities with deep domain expertise in pharmacovigilance, regulatory compliance, and technology. The analyst oversees end-to-end product roadmaps, ensuring alignment with business needs and drives platform upgrades, integrations, and compliance.Product Ownership & Roadmap:Manage the PV product roadmap, aligning it with business priorities.Oversee platform maintenance, rebuilding, and tech stack upgrades.Stay updated on latest pharmacovigilance and product technology trends.The Pharmacovigilance Product Analyst works closely with Business, Infrastructure, and Leadership teams to plan/manage product releases, downtime, incidents, and upgrades.As a key liaison across regulatory, clinical operations, QA, and IT functions, this role oversees safety system integrations ensuring accurate data flow and reporting.Ensure Argus acts as the central system, receiving case data from call centers, flowing through safety systems, and reaching regulatory authorities with compliance documentation.Support signal detection and reporting in line with global compliance and regulatory standards.Monitor and debug system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.Review AWS logs and system access for issue resolution.Collaborate with QA for system quality checks, validation, and signal monitoring.Gather and analyze requirements for PV systems and workflows.Document processes, data flows, and system functionalities related to adverse event reporting.Provide user training, support, and knowledge sharing.Required Skills and Qualifications:A Bachelor's degree in Life Sciences, Pharmacy, Information Technology, or a related field is required.Strong experience as a Product Analyst or Business Analyst in a regulated environment is required.Proven knowledge of pharmacovigilance processes and regulatory requirements is required.Familiarity with AWS, Cloud/SaaS platforms, and JIRA for incident/release management is required.PV systems: Argus, ArisG, Veeva Vault Safety are required.),

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