Pharmacovigilance Specialist

Opis posla

• Maintain oversight of areas of responsibility of the affiliate PV compliance status and escalate compliance issues in a timely manner
• Maintain awareness and monitor local post-marketing and clinical PV legislation, to ensure PV legislation changes are communicated to relevant stakeholders for review, impact
• Comply with local and regional PV regulations and the Affiliate PV System procedure(s)
• Monitor training compliance of affiliate personnel according to local contract requirements
• Manage any non-conformity and/or planned departures from corporate and/or local PV procedures according to the global issue and exception management process and ensure any corrective/preventive actions are completed according to the schedule
• Oversight of reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic and Aggregate Reports to the Regulatory Agency, Ethics Committees and Investigators, to comply with corporate PV procedures and with local and regional PV regulations as required
• For assigned projects, partner with Program Owners to ensure that all business partnerships involving activities where there is a reasonable possibility for the identification and/or handling of safety information are assessed for the generation of safety information and the applicable PV requirements are applied in accordance with AbbVie procedures and local requirements. Maintain and monitor compliance with local agreement.
• Support internal PV audits and Regulatory Agency PV inspections.
• Ensure a full and prompt response to regulatory agency requests assigned, for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product
• Ensure that a Disaster Recovery Plan/Business Continuity Plan is followed in a risk-based manner to allow for continuation of critical business processes for PV

CWA
• Coordinate PV activities across countries to ensure AbbVie’s statutory and ethical responsibilities are met
• Maintains oversight of required PV metrics in respective countries and provides comprehensive compliance metric reports to PV Dash (partner compliance metrics) to ensure full visibility of compliance issues
• Reports post-marketing Individual Case Safety Reports (ICSRs) via TRILOGY on behalf of local contracted PV personnel
• Ensures coordination of reporting of Periodic Safety Reports to the Regulatory Authority and Ethics Committees as required
• Ensures coordination of local RMP activities in accordance with AbbVie and national requirements
• Maintains oversight of safety compliance and follows up on local CAPAs.
• Reviews global requirements: SOLAR, SAM, COSMOS, and all other applicable PV systems
• Support coordination of Pharmacovigilance SOP
• Supports the process of utilizing / managing/ contracting of personnel across the region
• Assists with PV on-boarding and continuous coaching (mentoring)
• Coordinates process of performing of OOH tests – phone, websites, etc.
• Facilitates requests for action (PPS requests).
• Coordinates local contracted PV personnel on handling and implementing local regulatory requirements (HARD Intelligence).
• Monitors safety profile of marketed products through local PV personnel
• Supports the process of handling of SDE agreement

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