Argus Configuration Specialist

KEY RESPONSIBILITIES :

• Perform expert-level installation, configuration, and validation of Oracle Argus Safety and other relevant PV / Safety systems.
• Lead and execute significant customizations within Argus Safety to align with specific business needs.
• Demonstrate strong experience in Argus Business and System configuration, including workflows, user roles, security, and data entry forms.
• Provide sound technical architecture and design solutions for Argus Safety implementations and enhancements, based on user requirements and industry best practices.
• Translate business needs into technical specifications and configurations within the Argus platform.
• Possess excellent knowledge of SQL and PL / SQL for data extraction, manipulation, and reporting.
• Configure complex reports in Argus Aggregate and Periodic reports to meet regulatory and business intelligence requirements.
• Ensure all configurations and processes adhere to critical regulatory standards such as 21 CFR Part 11, ICH, and GxP.
• Demonstrate a strong understanding of global Pharmacovigilance regulations (e.g., EU, FDA, MFDS, NMPS, Mexico, Taiwan, and Russia).
• Lead and perform System Integration Testing (SIT) and User Acceptance Testing (UAT) as an integral part of Argus upgrade and implementation projects.
• Ensure validated systems meet all functional and non-functional requirements.
• Apply a good understanding of the Pharmacovigilance / Healthcare domain to interpret requirements and design effective solutions.
• Collaborate effectively with cross-functional teams, including business analysts, project managers, QA, and 3-8 years of relevant experience in Pharmacovigilance / Safety Knowledge :
• Good understanding of the Pharmacovigilance / Healthcare Expertise :
• Excellent knowledge of Oracle Argus Safety or other PV / Safety systems (e.g., ArisGlobal, PVWorks).
• Proven experience in installing, configuring, and validating Argus Safety, including significant customizations.
• Hands-on experience in Argus Business and System configuration.
• Experience in configuring reports in Argus Aggregate and Periodic Skills :
• Good knowledge of SQL and PL / SQL.
• Ability to provide technical architecture and design for PV Knowledge :
• Experience in regulatory standards like 21 CFR Part 11, ICH, GxP.
• Good understanding of global regulations (EU, FDA, MFDS, NMPS, Mexico, Taiwan, and Experience :
• Experience in performing System Integration and User Acceptance Testing (SIT and UAT) as part of upgrade / implementation Skills :
• Excellent analytical, problem-solving, research, and communication Bachelor's degree in Computer Science or a related field.

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