This position is accountable for executing the day-to-day operations and compliance activities to maintain high functioning PV systems across assigned region.
Metrics and Oversight of the Pharmacovigilance System
- Supports the provision of metrics that will ensure oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations and internal company timelines/standards.
Quality Management System
- Develops and maintains local/regional procedures in line with corporate procedures and local requirements.
- Performs the impact assessment of new/updated corporate policies, process, and procedures.
- Actively assists with the PV Exception Reporting/CAPA process.
- Actively assists with the business continuity plan and testing.
- Develops and maintains the local PSMF in line with AbbVie’s PV system master file, when required by local/regional regulations.
ICSR Management
- Records, processes, and conducts follow up and translates adverse events and other safety information from spontaneous and solicited sources.
- Performs ICSR expedited reporting according to the local requirements.
- Ensures local-language medical or scientific literature review.
- Implements an appropriate local quality control (QC) procedure to ensure quality of information entered and reporting decisions.
- Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures.
Periodic Safety Reporting
- Leads the preparation of periodic safety reports (e.g., PSUR)., local annexes, local variations, and translation of safety deliverable documents.
- Ensures submission of periodic safety reports and ensures documentation of evidence.
Audits and Inspection Management
- Actively assists in managing internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV Inspections.
- Actively assists in the development of CAPA in response to observations and the tracking actions to completion in a timely manner.
Partnership with business partner with possibility for identification and/or handling of safety
information
- Ensures all PV requirements are in place for activities where there is a reasonable possibility for the identification and/or handling of safety information in accordance with AbbVie procedures and local requirements.
PV Training
- Ensures overall training compliance with corporate procedures and local PV requirements, including the maintenance of the PV Training Matrix and the development of additional PV training materials, as required.