Pharmacovigilance Specialist - NQPPV Backup (Saudi National)

Overview

• Maintain the knowledge, training, access and availability required to fulfil the National QPPV Deputy role in accordance with Saudi regulations, AbbVie procedures and the approved country attestation or delegation documentation.
• Act for the National QPPV when formally delegated or when back-up coverage is activated, and support the National QPPV in maintaining oversight of the local pharmacovigilance system at all other times.
• Serve, as required, as a single local pharmacovigilance contact point for the Saudi health authority on a 24-hour basis and as a contact point for pharmacovigilance inspections.
• Remain permanently and continuously reachable in line with applicable local requirements, approved back-up arrangements and the affiliate business continuity plan.
• Maintain sufficient authority to influence the pharmacovigilance quality system and to promote, maintain and improve compliance with applicable legal and regulatory requirements.
• Ensure that delegated National QPPV activities, back-up arrangements and access to relevant medical expertise are clearly documented and kept current.
• Provide full and prompt responses to health authority requests for information required to evaluate the benefit-risk profile of a medicinal product.
• Provide input into regulatory actions arising from emerging safety concerns, including urgent safety restrictions and communications to healthcare professionals or patients, as applicable.
• Support oversight of the performance and functioning of the local pharmacovigilance system, including its quality system, procedures, contractual arrangements, databases, compliance data, audit outcomes and training requirements.
• Maintain access to the Pharmacovigilance System Master File and relevant national pharmacovigilance system files, and support confirmation that information relating to Saudi Arabia is accurate, complete and current.
• Review local pharmacovigilance activity metrics and compliance indicators. Identify risks, escalate issues promptly and track agreed actions to completion.
• Maintain awareness of the validation status and significant changes to relevant safety databases, including failures identified during validation and the corrective actions taken, where applicable.
• Collaborate with Regional Pharmacovigilance teams to provide the metrics, records and supporting information needed by the Affiliate Safety Representative and National QPPV to demonstrate system oversight.
• Monitor the effectiveness of local interfaces with Medical Affairs, Regulatory Affairs, Clinical, Quality, Commercial, Customer Service and other functions that may receive or generate safety information.
• Develop, implement and maintain local pharmacovigilance procedures in line with AbbVie corporate procedures, Saudi regulatory requirements and the local operating model.
• Ensure that local procedures adequately address back-up and delegation, training, local individual case safety reports, medical assessment support, seriousness and causality assessment, local literature screening, national pharmacovigilance system files, risk minimization measures, signal management, safety variations and periodic or aggregate reporting, as applicable.
• Manage non-conformities and planned departures from corporate or local pharmacovigilance

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at  www.abbvie.com . Follow @abbvie on  LinkedIn,   Facebook ,  Instagram ,  X  and  YouTube.

Job Summary

The Pharmacovigilance Specialist supports the Affiliate Safety Representative and Regional Pharmacovigilance Lead in coordinating and executing affiliate pharmacovigilance activities in Saudi Arabia. The role helps ensure that AbbVie meets its legal, regulatory, quality and ethical responsibilities for patient safety and maintains an effective local pharmacovigilance system.

The role serves as Back-up Affiliate Safety Representative and Saudi Arabia National Qualified Person for Pharmacovigilance Deputy. The incumbent maintains continuous readiness to act for the National QPPV and assumes delegated or back-up responsibilities when required. The role has sufficient access, authority and escalation channels to influence the performance of the pharmacovigilance quality system, support compliance with Saudi Good Pharmacovigilance Practice requirements and act as a pharmacovigilance contact for the Saudi health authority and AbbVie Global Patient Safety.

Primary Accountabilities

National QPPV Deputy and Regulatory Accountability

Oversight of the Pharmacovigilance System

Quality Management System and Procedures