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hace 1 semana
About the Job
We are seeking a highly skilled professional to join our team as a PV Operations Specialist. This individual will be responsible for executing day-to-day operations and compliance activities to maintain high-functioning pharmacovigilance systems across assigned regions.
Key Responsibilities
- Metric and Oversight: Ensure timely and accurate provision of metrics to support PV system performance and functionality.
- Quality Management System: Develop and maintain local quality management systems in accordance with corporate procedures and local requirements.
- ICSR Management: Manage ICSR processing, follow-up, and reporting in accordance with local regulations and AbbVie's PV system master file.
- Periodic Safety Reporting: Lead preparation and submission of periodic safety reports in compliance with local and international regulations.
- Audits and Inspection Management: Assist in managing audits and inspections to ensure compliance with regulatory requirements and AbbVie's PV system.
