Pharmacovigilance Specialist NQPPV Backup (Saudi National)

About AbbVie

AbbVie is dedicated to discovering and delivering innovative medicines and solutions to address serious health issues and future medical challenges. The company aims to make a significant impact on people's lives across key therapeutic areas, including immunology, oncology, neuroscience, and through its Allergan Aesthetics portfolio.

Role Overview

AbbVie is seeking a Pharmacovigilance Specialist - NQPPV Backup (Saudi National) to join its team in Riyadh. This full-time role supports the Affiliate Safety Representative and Regional Pharmacovigilance Lead in coordinating and executing pharmacovigilance activities within Saudi Arabia. The specialist ensures AbbVie meets its legal, regulatory, quality, and ethical responsibilities for patient safety and maintains an effective local pharmacovigilance system. The role requires 0-1 years of experience.

Key Responsibilities

• Serve as Back-up Affiliate Safety Representative and Saudi Arabia National Qualified Person for Pharmacovigilance Deputy.
• Maintain continuous readiness to act for the National QPPV and assume delegated or back-up responsibilities as required.
• Ensure sufficient access, authority, and escalation channels to influence the pharmacovigilance quality system's performance.
• Support compliance with Saudi Good Pharmacovigilance Practice requirements.
• Act as a pharmacovigilance contact for the Saudi health authority and AbbVie Global Patient Safety.
• Serve, as required, as a single local pharmacovigilance contact point for the Saudi health authority on a 24-hour basis and for pharmacovigilance inspections.
• Remain permanently and continuously reachable in line with local requirements, approved back-up arrangements, and the affiliate business continuity plan.
• Provide full and prompt responses to health authority requests for information to evaluate medicinal product benefit-risk profiles.
• Provide input into regulatory actions arising from emerging safety concerns, including urgent safety restrictions and communications to healthcare professionals or patients.

System Oversight and Compliance

• Support oversight of the local pharmacovigilance system's performance and functioning, 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, ensuring information related to Saudi Arabia is accurate, complete, and current.
• Review local pharmacovigilance activity metrics and compliance indicators, identifying risks, escalating issues promptly, and tracking agreed actions to completion.
• 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.

Delegation and Medical Support

Specific pharmacovigilance tasks may be delegated only to appropriately qualified and trained individuals, with documentation and oversight by the National QPPV or Deputy. If the appointed National QPPV Deputy has not completed medical training, formal documentation of ready access to qualified medically trained personnel is required in both parties' job descriptions or other approved role documentation. Delegation of individual tasks does not remove accountability for maintaining oversight of the local pharmacovigilance system and product safety profiles.

Qualifications and Requirements

• Saudi National.
• 0-1 years of experience.
• Maintain the knowledge, training, access, and availability required to fulfill the National QPPV Deputy role in accordance with Saudi regulations, AbbVie procedures, and approved country attestation or delegation documentation.
• Ensure delegated National QPPV activities, back-up arrangements, and access to relevant medical expertise are clearly documented and kept current.
• Maintain awareness of the validation status and significant changes to relevant safety databases, including identified failures and corrective actions.
• Collaborate with Regional Pharmacovigilance teams to provide metrics, records, and supporting information needed for system oversight.