Life Science Regulatory Compliance Specialist

Há 13 horas


Cajamar, Brasil Bebeepharmacovigilance Tempo inteiro

Job OverviewPharmacovigilance Product SpecialistThis role focuses on ensuring the integrity of pharmacovigilance systems and processes, guaranteeing accurate adverse event reporting, regulatory compliance, and efficient system management.Key Responsibilities:Develop and manage PV product roadmaps in line with business priorities,Oversee platform maintenance, upgrades, and rebuilding,Stay updated on latest pharmacovigilance and product technology trendsCollaboration and CommunicationStrong cross-functional collaboration skills are essential for this role.The candidate will work closely with business, infrastructure, and leadership teams to plan/manage product releases, downtime, incidents, and upgrades.Key Liaison Responsibilities:Serve as the key liaison across regulatory, clinical operations, QA, and IT functions,Oversee safety system integrations ensuring accurate data flow and reporting,Ensure compliance documentation reaches regulatory authorities in line with global standardsSystem Monitoring and Quality AssuranceMonitoring, debugging, and quality assurance are crucial skills for this role.The candidate will perform monitoring and debugging for system issues, review AWS logs and system access for issue resolution, and collaborate with QA for system quality checks.Key System Responsibilities:Gather and analyze requirements for PV systems and workflows,Document processes, data flows, and system functionalities related to adverse event reporting,Support validation and user acceptance testing (UAT)Required QualificationsRequired qualifications include a Bachelor's degree in Life Sciences, Pharmacy, Information Technology, or related field, and strong experience as a Product Analyst or Business Analyst in a regulated environment.Key Qualifications:Familiarity with AWS, Cloud/SaaS platforms,Experience with JIRA for incident/release managementTools and TechnologiesTools and technologies include PV systems such as Argus, ArisG, Veeva Vault Safety.



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