Senior Pharmacovigilance Systems Specialist

1 semana atrás


Salvador, Brasil Bebeebusiness Tempo inteiro

As a critical liaison between business stakeholders, regulatory teams, and IT professionals, this role plays a pivotal part in supporting pharmacovigilance systems and workflows.Maintaining patient safety, regulatory compliance, and operational efficiency is paramount to success in this position.The successful candidate will collaborate across teams to gather requirements, implement solutions, and provide support for pharmacovigilance systems such as Argus, ArisG, and Veeva Vault Safety.Key responsibilities include gathering and analyzing requirements for pharmacovigilance systems and workflows, working with business users, regulatory teams, and IT to implement or enhance safety systems.Documenting business processes, data flows, and system functionalities related to adverse event reporting is also essential.To ensure compliance with global regulatory standards (FDA, EMA, MHRA), the Business Analyst will work closely with cross-functional teams including regulatory affairs, clinical operations, and IT.Additionally, this role requires providing support and training to end-users on safety systems and processes, as well as collaborating with regulatory teams to validate and user-acceptance test PV systems.



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