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.
