Argus Axway Consultant

Job Description

Job Description:

We are looking for a highly skilled Senior Argus/Axway (EDI) Consultant with strong hands-on experience in Argus Safety, E2B configuration, Axway, and SQL.

The ideal candidate will have deep functional and technical knowledge of pharmacovigilance systems and will be responsible for configuring, maintaining, and enhancing Argus workflows and integrations.

Roles & Responsibilities

• Configure, manage, and optimize Argus Safety modules/EDI setup and workflows.
  
• Handle E2B (R2/R3) configuration, testing, validation, and troubleshooting for regulatory reporting with end-to-end EDI agency setup (FDA/EMA/MHRA).
  
• Integrate Argus with external systems using Axway (or other gateway tools)/Transmission UAT/EDI setup in Argus and Axway Interface.
  
• Perform data extraction, validation, and report generation using SQL/Knowledge about Interchange Tables, MSG, ACK, Safety Report Troubleshooting.
  
• Work closely with PV operations, QA, and IT teams to ensure smooth case processing and compliance/Including Axway EDI status updates on UI.
  
• Lead system upgrades, patching, migration activities, and UAT/Work with Axway Support if needed.
  
• Ensure compliance with global pharmacovigilance regulations and data integrity standards.
  
• Provide technical support, issue resolution, and performance optimization.
  
• Document configurations, change requests, and system procedures.
  

Requirements

Key Responsibilities

• 5 to 8+ years of experience working with Argus Safety in pharmaceutical or life sciences environments.
  
• Strong expertise in E2B Exchange (R2/R3) configuration/ICH E2B guidelines review and validation.
  
• Hands-on experience with Axway Gateway for E2B transmission/Troubleshooting Negative ACK.
  
• Proficiency in SQL for data queries, troubleshooting, and analysis.
  
• Solid understanding of global PV regulations (FDA, EMA, MHRA, ICH).
  
• Experience in Argus upgrades, schema changes, and system validation (CSV).
  
• Strong problem-solving, communication, and stakeholder management skills.
  

Good to Have:

• Experience with safety database migrations.
  
• Knowledge of REST/SOAP web services for Argus integrations.
  
• Familiarity with reporting tools (Cognos / OBIEE / Spotfire).
  

Requirements
Required Skills & Experience: • Strong hands-on experience with Microsoft Active Directory (installation, multi-forest/domain management, GPO, DNS/DHCP, Trust, AD replication). • In-depth knowledge of Microsoft Entra ID (Azure AD), especially password protection features and custom banned password lists. • Experiences in monitoring, analytics tools like SCOM, Zabbix, Splunk, Azure log analytics, ELK etc. • Advanced PowerShell scripting skills for automation and reporting. • Experience with regulatory compliance projects (e.g., HKMA C-RAF, SOX, GDPR) is a plus. • Excellent analytical, troubleshooting, and communication skills. • 10-15 years of IT experience, with at least 5 years in AD/Entra ID environments. Preferred Certifications: • Microsoft Certified for AD and Entra ID. Education level: Degree or equivalent in engineering/ IT field