Senior Technology Lead - Pharmacovigilance Systems

Soterius, Inc.; Dadri; On-site; INR 3,500,000 - 6,500,000; Full time

Job summary

Soterius is seeking a hands-on Senior Technology Lead to drive implementation, validation, migration, and lifecycle management of GxP-regulated Pharmacovigilance (PV) systems. This role combines technical execution with solution oversight, ensuring compliant, scalable PV technology environments across global client engagements.

The ideal candidate is an execution-focused technology leader with strong regulatory knowledge, system validation expertise, and experience managing complex PV systems.

Qualifications

• Bachelor’s degree in computer science, information technology, life sciences, or related field (Master’s preferred).
• 8+ years of experience in Pharmacovigilance systems and GxP-regulated environments.
• Strong knowledge of global regulatory requirements (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).
• Demonstrated experience in validated system implementation and lifecycle management.

Responsibilities

• PV System Implementation & Lifecycle Management- Lead and execute configuration, implementation, upgrades, and managed services for validated PV platforms (e.g., Argus, ArisGlobal, Veeva Safety).
• Computer System Validation (CSV/CSA) & Compliance Execution- Develop and execute validation deliverables (URS, FS, DS, IQ/OQ/PQ, traceability matrices) per regulatory standards.
• System Migration & Data Integrity Oversight- Plan and execute safety database migrations (cloud/on-prem), ensuring data integrity and audit trail continuity.
• Technical Optimization & Automation- Leverage scripting, reporting tools, and AI-enabled tech to enhance PV workflows and reporting.
• Vendor & Stakeholder Collaboration- Coordinate with vendors, QA, PV operations, and client stakeholders to manage enhancements and roadmaps.

Skills

PV systems knowledge

Regulatory knowledge

Validation experience

Automation scripts

Education

Bachelor’s degree in CS/IT/Life Sciences

Master’s preferred

Tools

Oracle Argus

ArisGlobal LifeSphere

Veeva Safety

Job description

Senior Technology Lead - Pharmacovigilance Systems

4-8 years

Noida

Full-Time

Role Summary

Soterius is seeking a hands-on Senior Technology Lead to drive implementation, validation, migration, and lifecycle management of GxP-regulated Pharmacovigilance (PV) systems. This role combines technical execution with solution oversight, ensuring compliant, scalable, and secure PV technology environments across global client engagements.

The ideal candidate is an execution-focused technology leader with strong regulatory knowledge, system validation expertise, and experience managing complex PV systems.

Key Responsibilities

• PV System Implementation & Lifecycle Management- Lead and execute configuration, implementation, upgrades, and managed services for validated PV platforms (e.g., Argus, ArisGlobal, Veeva Safety), ensuring operational efficiency and regulatory compliance.
• Computer System Validation (CSV/CSA) & Compliance Execution- Develop and execute validation deliverables (URS, FS, DS, IQ/OQ/PQ, traceability matrices) in alignment with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Support internal and external audits and ensure inspection readiness.
• System Migration & Data Integrity Oversight - Plan and execute safety database migrations (cloud/on-prem), ensuring data integrity, audit trail continuity, risk mitigation, and secure infrastructure management.
• Technical Optimization & Automation - Leverage scripting, reporting tools, and AI-enabled technologies to enhance PV workflows, automate processes, and improve system performance and reporting capabilities.
• Vendor & Stakeholder Collaboration - Coordinate with system vendors, QA, PV operations, and client stakeholders to manage enhancements, resolve technical issues, and contribute to technology roadmap discussions.

Qualifications

• Bachelor’s degree in computer science, Information Technology, Life Sciences, or related field (Master’s preferred).
• 8+ years of experience in Pharmacovigilance systems and GxP-regulated environments.
• Strong knowledge of global regulatory requirements (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).
• Demonstrated experience in validated system implementation and lifecycle management.
• Solid understanding of data integrity principles and audit trail compliance.

Experience

• Hands-on experience with leading PV platforms (e.g., Oracle Argus, ArisGlobal LifeSphere, Veeva Safety, or equivalent).
• Proven track record in large-scale PV system migrations and integrations.
• Experience preparing and reviewing CSV/CSA documentation in regulated environments.
• Familiarity with cloud-based deployments (AWS/Azure) and secure infrastructure practices.
• Practical exposure to scripting, database queries (SQL), reporting tools, or automation/AI applications in PV systems.
• Experience working with global clients across US, EU, UK, and APAC regions.

Preferred Attributes

• Strong problem-solving and technical troubleshooting capability.
• Ability to balance execution with strategic thinking.
• Experience in managed services delivery models.
• Excellent communication skills with ability to interact with both technical and business stakeholders.