Pharmacovigilance Specialist NQPPV Backup (Saudi National)

About the Role

AbbVie is seeking a Pharmacovigilance Specialist to join its team in Riyadh, Saudi Arabia. This full-time role supports the Affiliate Safety Representative and Regional Pharmacovigilance Lead in coordinating and executing pharmacovigilance activities within Saudi Arabia. The specialist helps ensure that AbbVie meets its legal, regulatory, quality, and ethical responsibilities for patient safety and maintains an effective local pharmacovigilance system. The position requires 2-5 years of experience.

Key Responsibilities

• Serve as the Back-up Affiliate Safety Representative and Deputy for the Saudi Arabia National Qualified Person for Pharmacovigilance (NQPPV).
• Maintain continuous readiness to act for the National QPPV and assume delegated or back-up responsibilities when required.
• Act as a single local pharmacovigilance contact point for the Saudi health authority on a 24-hour basis and for pharmacovigilance inspections.
• Support oversight of the local pharmacovigilance system, including its quality system, procedures, contractual arrangements, 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 when establishing or managing activities where safety information may be identified or handled.
• Maintain oversight of the affiliate pharmacovigilance training plan and ensure required training completion.
• Support internal pharmacovigilance audits, audits of service providers, and inspections conducted by health authorities.
• Act as a subject matter expert on Saudi pharmacovigilance regulations, guidance, and policy.
• Support local risk management activities and coordinate the receipt and distribution of Risk Management Plans.
• Maintain an overview of product safety profiles and emerging safety concerns for company products marketed in Saudi Arabia.
• Support the Affiliate Safety Representative in developing local safety and pharmacovigilance strategies for product launches.

Authority and Relationships

This role reports to the Affiliate Safety Representative / Pharmacovigilance Lead. The incumbent will have direct access to relevant affiliate leadership, the Affiliate Medical Director, Regional Pharmacovigilance leadership, the QPPV Office, and Global Patient Safety to raise safety or compliance concerns and obtain timely support.

Internal and External Interactions

Internal relationships include 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 involve Saudi health authorities, ethics committees, investigators, healthcare professionals, consumers, patients, distributors, licensing partners, and service providers.

Qualifications

• Proven experience in pharmacovigilance, with 2-5 years of relevant experience.
• Ability to maintain knowledge, training, access, and availability to fulfill the National QPPV Deputy role.
• Demonstrated ability to influence the pharmacovigilance quality system and promote compliance with legal and regulatory requirements.
• Strong understanding of Saudi pharmacovigilance regulations, guidance, and policy.
• Capacity to coordinate and document pharmacovigilance training for partners and contracted parties.
• Saudi National.

Work Environment

This is a full-time position based in Riyadh, Saudi Arabia, operating within a dynamic pharmaceutical environment. The role requires continuous readiness and responsiveness to ensure patient safety and regulatory compliance.