Senior Oracle Argus Safety Specialist (PV & Compliance)

Excelya; Boulogne-Billancourt; On-site; EUR 70,000 - 100,000; Full time

Job summary

Excelya in France seeks a Senior Oracle Argus Safety Consultant to maintain, optimize, and shape a global pharmacovigilance platform, partnering with business, compliance, and IT stakeholders.

The role covers configuring Argus, leading testing, and driving regulatory reporting, data integrity, and migration readiness.

You will translate regulatory needs into scalable system solutions and manage risk while guiding change and validation across projects.

Qualifications

• Bachelor's or Master's degree in Pharmacy.
• Strong experience with Oracle Argus Safety in a functional admin, system expert, or business analyst role within pharma/biotech/CRO.
• Proven ability to configure Argus in a GxP-regulated environment.

Responsibilities

• Manage and maintain Oracle Argus Safety configurations (products, licenses, studies, destinations, agreements, system parameters).
• Design, test, and document regulatory reporting rules using SQL-based logic and advanced conditions.
• Oversee E2B message flows and mappings for compliant data exchanges and reliable submissions.
• Act as the functional expert translating regulatory and operational needs into compliant configurations.
• Investigate root causes of data or reporting discrepancies and assess related risks.
• Lead change management and validation activities, including test strategy and regression testing.
• Provide expert support for complex incidents and coordinate with PV stakeholders and IT/vendors.
• Support Argus reconfiguration projects, including migration planning and transition readiness.

Skills

Regulatory reporting

E2B mappings

System troubleshooting

Impact assessments

Testing

Change management

Stakeholder management

Problem solving

Education

Bachelor's or Master's in Pharmacy

Tools

Oracle Argus Safety

Job description

Excelya in France seeks a Senior Oracle Argus Safety Consultant to maintain, optimize, and shape a global pharmacovigilance platform, partnering with business, compliance, and IT stakeholders.

The role covers configuring Argus, leading testing, and driving regulatory reporting, data integrity, and migration readiness.

You will translate regulatory needs into scalable system solutions and manage risk while guiding change and validation across projects.