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.
