1. Job Overview
We are looking for a Pharmacovigilance Technology Specialist with 4–5 years of experience in pharmacovigilance and safety database management. The role will support safety database implementation, system enhancements, data migration, AI and automation initiatives, and regulatory compliance to improve PV technology solutions and operational efficiency.
2. Key Responsibilities
- Support implementation, configuration, maintenance, and management of safety databases such as Argus and ArisGlobal.
- Assist with data migration, mapping documents, and regulatory gateways, including E2B/ICSR data exchange.
- Coordinate system upgrades, enhancements, validation, troubleshooting, and ongoing support.
- Support the identification and implementation of AI and automation solutions in PV processes.
- Gather business requirements and prepare user requirement specifications and functional documents.
- Ensure compliance with GxP, CSV, and applicable regulatory requirements.
- Support audits, inspections, SOP management, and validation documentation.
- Coordinate with PV operations, IT, QA, developers, and cross-functional stakeholders.
- Manage assigned projects and tasks within agreed timelines and quality standards.
3. Required Skills and Experience
- 4–5 years of experience in Pharmacovigilance, with exposure to safety database management and technology solutions.
- Working knowledge of Argus, ArisGlobal, or other PV safety databases.
- Experience in system configuration, data migration, upgrades, and enhancements.
- Understanding of CSV, GxP, GAMP 5, 21 CFR Part 11, and EU Annex 11.
- Knowledge of global PV regulations and E2B/ICSR reporting standards.
- Familiarity with AI, automation, and emerging PV technologies.
- Understanding of PV processes, including case processing, aggregate reporting, and signal management.
- Strong analytical, problem-solving, communication, and stakeholder management skills.
- Ability to manage multiple priorities and deliver within defined timelines.
