Argus Safety Configuration Specialist

About the role

EY’s Regulatory Compliance team seeks an Argus Safety Configuration Specialist to lead global pharmacovigilance technology and regulatory compliance transformation programs. The role involves configuring, validating, and governing Oracle Argus Safety solutions to ensure alignment with global regulatory expectations and client SOPs. This position is based in Bengaluru, India.

What you’ll do

• Lead end-to-end Oracle Argus Safety configuration, enhancement, and upgrade activities.
• Own advanced system configuration, customization, validation, and governance.
• Ensure compliance with global PV regulations and GxP requirements.
• Lead integrations, data migrations, testing, and inspection readiness.
• Manage project teams and senior client stakeholders.
• Mentor junior team members and contribute to internal initiatives.
• Support clients in strengthening patient safety and system governance.
• Drive projects to completion with high-quality deliverables.

What you’ll bring

• Bachelor’s or master’s degree in Life Sciences, Biotech, Pharmacy, Nursing, or related field.
• 8-12 years of experience with pharmacovigilance systems.
• Hands-on exposure to Argus Safety configuration and validation.
• Advanced Oracle Argus Safety 8.x and above configuration expertise.
• Proficiency in SQL and PL/SQL for custom report development.
• Experience with E2B R2/R3 reporting configuration and gateway setup.
• Knowledge of MedDRA and WHO Drug dictionary configuration.
• Strong understanding of ICH E2B(R3), EU GVP, and 21 CFR Part 11.

Skills

Benefits

• Support, coaching, and feedback from engaging colleagues.
• Opportunities to develop new skills and progress career.
• Freedom and flexibility to handle the role appropriately.
• Individual progression plan for personal development.

Education

Bachelor’s or master’s degree in Life Sciences, Biotech, Pharmacy, Nursing, or related field.