Responsibilities:
Metrics and Oversight of the Pharmacovigilance System
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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
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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.
Legislation Intelligence
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Monitors local (and applicable regional/area) PV-relevant hard intelligence, leading the impact assessment of them.
After Hours Availability & Business Continuity