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This role is responsible for ensuring the high functioning of PV systems across assigned regions. The incumbent will work closely with the PV Operational Team Lead or Regional PV Lead to execute day-to-day operations and compliance activities.
Key Responsibilities- Support the provision of metrics to ensure oversight of all aspects of PV system performance and functioning in compliance with local regulations and internal company timelines/standards.
- Develop and maintain local/regional procedures in line with corporate procedures and local requirements.
- Perform impact assessments of new/updated corporate policies, processes, and procedures.
- Assist with the PV Exception Reporting/CAPA process.
- Develop and maintain the local PSMF in line with AbbVie's PV system master file, as required by local/regional regulations.
- Record, process, and conduct follow-up on adverse events and other safety information from spontaneous and solicited sources.
- Perform ICSR expedited reporting according to local requirements.
- Ensure local-language medical or scientific literature review.
- Implement an appropriate local quality control (QC) procedure to ensure quality of information entered and reporting decisions.
- Complete AE reconciliation and ensure AE identification effectiveness sampling consistent with global procedures.
- Lead the preparation of periodic safety reports (e.g., PSUR), local annexes, local variations, and translation of safety deliverable documents.
- Ensure submission of periodic safety reports and document evidence.
