Pharmacovigilance Specialist NQPPV Backup (Saudi National)

About the Role

AbbVie is seeking a Pharmacovigilance Specialist NQPPV Backup to join their team in Riyadh, Saudi Arabia. This full-time role requires 2-5 years of experience and supports the Affiliate Safety Representative and Regional Pharmacovigilance Lead in coordinating and executing pharmacovigilance activities within Saudi Arabia.

The specialist will help ensure AbbVie meets its legal, regulatory, quality, and ethical responsibilities for patient safety and maintains an effective local pharmacovigilance system. This position also serves as the Back-up Affiliate Safety Representative and Deputy for the Saudi Arabia National Qualified Person for Pharmacovigilance (NQPPV).

Key Responsibilities

• Maintain knowledge, training, access, and availability to fulfill the NQPPV Deputy role in accordance with Saudi regulations and AbbVie procedures.
• Act for the National QPPV when formally delegated or when back-up coverage is activated, and support oversight of the local pharmacovigilance system.
• Serve as a single local pharmacovigilance contact point for the Saudi health authority on a 24-hour basis and for pharmacovigilance inspections, as required.
• Support oversight of the performance and functioning 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 when establishing or managing activities where safety information may be identified or handled.
• Maintain oversight of the affiliate pharmacovigilance training plan and ensure personnel complete required training.
• Support internal pharmacovigilance audits, service provider audits, and health authority inspections.
• Act as a subject matter expert on Saudi pharmacovigilance regulations, guidance, and policy.
• Support local risk management activities and coordinate receipt and distribution of Risk Management Plans.
• Maintain an overview of product safety profiles and emerging safety concerns for products marketed in Saudi Arabia.
• Support the Affiliate Safety Representative in developing a local safety and pharmacovigilance strategy for product and indication launches.

Authority and Key Relationships

This role reports to the Affiliate Safety Representative / Pharmacovigilance Lead. The incumbent must 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 Relationships

• Affiliate Medical Affairs, Regulatory Affairs, Clinical, Quality Assurance, Commercial, Marketing, Sales, Operations, Customer Service, Medical Information, and Product Quality personnel.
• Global Patient Safety, including the Regional Pharmacovigilance Lead, Area Pharmacovigilance Head, Area Pharmacovigilance Product Lead, QPPV Office, Risk Management teams, and other relevant safety functions.

External Relationships

• Saudi health authorities responsible for product safety, including pharmacovigilance inspectors.
• Ethics committees, investigators, healthcare professionals, consumers, and patients, as appropriate.
• Distributors, licensing partners, service providers, and other third parties that may identify, receive, process, or exchange safety information.

Qualifications and Requirements

• 2-5 years of experience in a related field.
• Ability to maintain continuous readiness to act for the National QPPV and assume delegated or back-up responsibilities.
• Sufficient access, authority, and escalation channels to influence the performance of the pharmacovigilance quality system.
• Capacity to support compliance with Saudi Good Pharmacovigilance Practice requirements.
• Ability to act as a pharmacovigilance contact for the Saudi health authority and AbbVie Global Patient Safety.
• Formal documentation of ready access to appropriately qualified medically trained personnel if the appointed NQPPV Deputy has not completed medical training.