Pharmacovigilance Specialist - NQPPV Backup (Saudi National)

Job description

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 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. Oversight of the Pharmacovigilance System 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. Quality Management System and Procedures 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 procedures through the applicable global issue and exception management process. Support the development, implementation and timely completion of corrective and preventive actions. Maintain controlled records that demonstrate compliance with local requirements and AbbVie procedures. Adverse Events and Safety Reporting Support processes for the intake, processing, translation, follow-up, medical assessment support and reconciliation of adverse events and other safety information from spontaneous reports, solicited programs, clinical studies, product complaints and other reportable sources. Partner with Regional Pharmacovigilance teams to ensure timely submission of clinical and post-marketing individual case safety reports to the Saudi health authority, ethics committees and investigators, as required. Support the production, review and submission of periodic and aggregate safety reports, including periodic safety update reports, periodic benefit-risk evaluation reports and development safety update reports, as applicable. Help ensure that pharmacovigilance data submitted to health authorities are correct, complete, traceable and submitted within applicable timelines. Support reconciliation of safety data with product complaints, medical information, organized data collection programs and other identified sources. Safety Data Sources and Business Partnerships Act as a safety advisor to affiliate cross-functional teams when establishing or managing activities in which safety information may be identified or handled. Ensure that all local sources of adverse events and other safety information are identified and that mechanisms are in place for their collection, transfer and reconciliation with Global Patient Safety. Partner with Regional Pharmacovigilance teams to develop, review and maintain Safety Data Exchange Agreements and other pharmacovigilance agreements in line with AbbVie procedures and Saudi requirements. Maintain the local inventory of pharmacovigilance agreements in the designated system and monitor compliance with contractual safety obligations. Coordinate and document pharmacovigilance training for partners, service providers and other contracted parties according to the relevant agreement and local requirements. Pharmacovigilance Training Maintain oversight of the affiliate pharmacovigilance training plan and training matrix. Ensure that local pharmacovigilance personnel, affiliate employees and relevant contractors complete required corporate and local pharmacovigilance training within defined timelines. Develop or adapt local training materials when required and retain appropriate training records. Promote clear understanding across the affiliate of individual responsibilities for identifying and reporting safety information. Audits and Inspections Support internal pharmacovigilance audits, audits of service providers or third parties and inspections conducted by health authorities. Coordinate inspection readiness activities and ensure prompt access to relevant procedures, records, system in