Pharmacovigilance Specialist NQPPV Backup (Saudi National)

About AbbVie and the Role

AbbVie is dedicated to discovering and delivering innovative medicines and solutions to address serious health issues. The company focuses on therapeutic areas including immunology, oncology, neuroscience, and Allergan Aesthetics. This full-time role for a Pharmacovigilance Specialist NQPPV Backup (Saudi National) is based in Riyadh, Saudi Arabia, and requires 2-5 years of experience.

Role Summary

The Pharmacovigilance Specialist supports the Affiliate Safety Representative and Regional Pharmacovigilance Lead in coordinating and executing pharmacovigilance activities within Saudi Arabia. This position ensures AbbVie meets its legal, regulatory, quality, and ethical responsibilities for patient safety and maintains an effective local pharmacovigilance system. The specialist also serves as the Back-up Affiliate Safety Representative and Deputy for the Saudi Arabia National Qualified Person for Pharmacovigilance (NQPPV), maintaining continuous readiness to assume delegated or back-up responsibilities as needed. The role includes sufficient access and authority to influence the pharmacovigilance quality system and ensure compliance with Saudi Good Pharmacovigilance Practice requirements.

Key Responsibilities

• Maintain knowledge, training, and availability for the National QPPV Deputy role, acting for the National QPPV when delegated or during back-up activation.
• Serve as a 24-hour local pharmacovigilance contact point for the Saudi health authority and for pharmacovigilance inspections.
• Support oversight of the local pharmacovigilance system, including its quality system, procedures, and compliance data.
• Develop, implement, and maintain local pharmacovigilance procedures in line with AbbVie corporate procedures and Saudi regulatory requirements.
• Support processes for the intake, processing, translation, follow-up, and reconciliation of adverse events and other safety information.
• Act as a safety advisor to affiliate cross-functional teams and ensure identification and collection of all local sources of safety information.
• Oversee the affiliate pharmacovigilance training plan and ensure completion of required training for personnel and contractors.
• Support internal pharmacovigilance audits and health authority inspections, coordinating readiness activities and assisting with responses.
• Act as a subject matter expert on Saudi pharmacovigilance regulations and monitor for new or revised requirements.
• Support local risk management activities, coordinating the receipt and distribution of Risk Management Plans and additional risk minimization measures.
• Maintain an overview of product safety profiles and emerging safety concerns for products marketed in Saudi Arabia.
• Support the Affiliate Safety Representative in developing local safety and pharmacovigilance strategies for product launches.

Qualifications and Experience

• 2-5 years of relevant experience in pharmacovigilance.
• Ability to maintain continuous readiness to act as the National QPPV Deputy.
• Demonstrated authority to influence the pharmacovigilance quality system and promote compliance.
• Strong understanding of Saudi pharmacovigilance regulations, guidance, and policy.
• Capability to manage non-conformities and planned departures from pharmacovigilance procedures.
• Excellent collaboration skills with regional pharmacovigilance teams and cross-functional departments.
• For non-medically trained deputies, formal documentation of ready access to appropriately qualified medically trained personnel is required.

Reporting Structure and Relationships

This role reports to the Affiliate Safety Representative / Pharmacovigilance Lead. Direct access to relevant affiliate leadership, the Affiliate Medical Director, Regional Pharmacovigilance leadership, the QPPV Office, and Global Patient Safety is essential for raising safety or compliance concerns and obtaining timely support.

Internal Relationships: Includes Medical Affairs, Regulatory Affairs, Clinical, Quality Assurance, Commercial, Marketing, Sales, Operations, Customer Service, Medical Information, Product Quality personnel, and various Global Patient Safety teams.

External Relationships: Involves Saudi health authorities, ethics committees, investigators, healthcare professionals, consumers, patients, distributors, licensing partners, service providers, and other third parties involved in safety information exchange.