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We are seeking an experienced Argus Safety Consultant with strong knowledge of pharmacovigilance systems and drug safety processes. The consultant will be responsible for configuring, supporting, and optimizing the Oracle Argus Safety platform to ensure efficient case processing, regulatory compliance, and safety data management.
Job Responsibility:
Configure and support Oracle Argus Safety modules including case processing, workflows, and reporting
Manage pharmacovigilance activities such as ICSR processing, case management, and regulatory submissions
Perform system configuration, validation support, and user access management
Troubleshoot Argus issues and provide production support
Integrate Argus with safety systems and support data migration activities
Work with business and PV teams to gather requirements and implement solutions
Requirements:
Strong experience with Oracle Argus Safety configuration and support
Knowledge of pharmacovigilance processes, ICSR, MedDRA, and regulatory reporting
Experience with E2B(R3) submissions and safety database management
Good understanding of drug safety regulations (FDA, EMA)