Safety Systems Analyst

1 dia atrás

Ituiutaba, Brasil Bebeepharmacovigilance Tempo inteiro

As a liaison between business stakeholders, regulatory teams and IT professionals, the Adverse Event Reporting Specialist plays a crucial role in ensuring pharmacovigilance systems and workflows support accurate and compliant adverse event reporting.This position is critical in maintaining patient safety, regulatory compliance and efficient operations.Determine and analyze requirements for pharmacovigilance systems and workflows.Collaborate with business users, regulatory teams and IT to implement or enhance safety systems.Document business processes, data flows and system functionalities related to adverse event reporting.Ensure adherence to global regulatory standards.Support validation and user acceptance testing of PV systems.Provide training and support to end-users on safety systems and processes.The ideal candidate will have a Bachelor's degree in a relevant field, in-depth knowledge of pharmacovigilance processes and regulatory requirements, and hands-on experience with safety systems.Familiarity with adverse event reporting workflows and compliance processes, as well as understanding of global regulations, is also desirable.

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