Senior Technology Lead - Pharmacovigilance Systems
soterius· Pharmacovigilance Technology Solutions
About this role
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.
Frequently Asked Questions
Is the salary disclosed for the Senior Technology Lead - Pharmacovigilance Systems position at soterius?
The salary for this Senior Technology Lead - Pharmacovigilance Systems role at soterius is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Senior Technology Lead - Pharmacovigilance Systems position at soterius located?
This Senior Technology Lead - Pharmacovigilance Systems role at soterius is based in Noida, UP, India. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Senior Technology Lead - Pharmacovigilance Systems role at soterius full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Senior Technology Lead - Pharmacovigilance Systems role in the Pharmacovigilance Technology Solutions department at soterius.
Which team or department does the Senior Technology Lead - Pharmacovigilance Systems at soterius belong to?
This Senior Technology Lead - Pharmacovigilance Systems position is part of the Pharmacovigilance Technology Solutions department at soterius. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Senior Technology Lead - Pharmacovigilance Systems position at soterius?
Click the "Apply Now" button on this page. You will be redirected to soterius's official application portal hosted on keka where you can submit your application directly.
When was the Senior Technology Lead - Pharmacovigilance Systems job at soterius posted?
This Senior Technology Lead - Pharmacovigilance Systems position at soterius was posted on Sep 8, 2026. Apply as soon as possible — early applications are often reviewed first.
Senior Technology Lead - Pharmacovigilance Systems
soterius
You'll be redirected to soterius's official application page on keka.