Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
We are looking for a Senior Oracle Argus Safety Consultant to play a key role in maintaining, optimizing, and shaping the future of a global pharmacovigilance platform, while acting as a trusted partner to business, compliance, and technical stakeholders.
Key responsibilities :
- Manage and maintain advanced Oracle Argus Safety configurations, including products, licenses, studies, reporting destinations, agreements, and system parameters.
- Design, configure, test, and document complex regulatory reporting rules, including the use of SQL-based logic and advanced reporting conditions.
- Oversee E2B message flows and mappings, ensuring compliant data exchanges, successful testing, and reliable submission processes.
- Act as the functional expert for business requirements analysis, translating regulatory and operational needs into robust, compliant system configurations.
- Perform end-to-end investigations to identify root causes of system, data, or reporting discrepancies and assess associated business and compliance risks.
- Lead change management and validation activities, including impact assessments, test strategy definition, user acceptance criteria, and regression testing.
- Provide expert support for complex incidents, collaborate with business, IT, vendors, and PV stakeholders, and proactively manage risks impacting compliance or operational continuity.
- Support the strategic Argus reconfiguration project, contributing to target-state design, gap analysis, functional architecture decisions, migration planning, and transition readiness.
Requirements
At Excelya, we encourage taking daring steps, so we seek individuals who are ready to advance with our mission and embody our values.
- Education: Bachelor’s or Master’s degree in Pharmacy
- Experience: Strong experience with Oracle Argus Safety in a functional administration, system expert, or business analyst role within a pharmaceutical company, biotech, or CRO environment. Proven experience managing complex Argus configurations in a GxP-regulated environment.
- Skills: Advanced expertise in Oracle Argus Safety configuration, regulatory reporting rules, E2B message flows and mappings, system troubleshooting, impact assessments, testing, and change management. Ability to translate business and regulatory requirements into compliant, scalable, and maintainable system solutions. Strong stakeholder management and problem-solving skills.
- Knowledge : Solid understanding of global Pharmacovigilance processes, international regulatory requirements, E2B standards, GxP compliance, data integrity, and computerized system validation principles.
- Languages: Fluent in English; additional languages are considered an asset.
Benefits
Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here's what makes us unique
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model offering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
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