Senior Technology Lead Pharmacovigilance Systems

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.