Pharmacovigilance Specialist - NQPPV Backup (Saudi National)

Pharmacovigilance Specialist – NQPPV Backup (Saudi National)

At AbbVie, we are dedicated to advancing patient safety through innovative medicines and rigorous compliance with global and regional regulatory standards. We are seeking a highly skilled Pharmacovigilance Specialist to serve as the National Qualified Person for Pharmacovigilance (NQPPV) Deputy and Backup Affiliate Safety Representative for Saudi Arabia, ensuring our commitment to excellence in pharmacovigilance is upheld with precision and responsibility.

In this pivotal role, you will play a critical part in safeguarding patient well-being by overseeing and executing pharmacovigilance activities in alignment with Saudi regulatory requirements, AbbVie’s global standards, and local health authority expectations. This position demands a proactive, detail-oriented professional with a deep understanding of pharmacovigilance principles, regulatory compliance, and the ability to act decisively in high-stakes scenarios.

Key Responsibilities

As the NQPPV Deputy, you will:

• Act as the primary backup for the National QPPV, ensuring seamless continuity of pharmacovigilance oversight in Saudi Arabia, including formal delegation when required. This involves maintaining 24/7 availability to serve as the single point of contact for Saudi health authority inquiries, inspections, and urgent safety communications.
• Lead and document all delegated NQPPV activities, back-up protocols, and access to critical medical expertise, ensuring full compliance with Saudi Good Pharmacovigilance Practice (GVP) and AbbVie’s internal policies.
• Promote and enforce a robust pharmacovigilance quality system, ensuring adherence to legal, regulatory, and ethical obligations while influencing system improvements and compliance initiatives.
• Collaborate closely with the Regional Pharmacovigilance team to provide accurate metrics, records, and insights, supporting global patient safety efforts while aligning with local priorities.

Additionally, you will:

• Oversee the local pharmacovigilance system, including databases, compliance audits, training programs, and contractual arrangements, to ensure accuracy, completeness, and continuous improvement.
• Monitor and analyze pharmacovigilance activity metrics, compliance indicators, and audit outcomes, identifying risks and escalating issues promptly to mitigate potential safety concerns.
• Maintain up-to-date access to the Pharmacovigilance System Master File and relevant national documentation, verifying that all Saudi Arabia-specific information is current and compliant.
• Provide timely responses to health authority requests, including benefit-risk evaluations, regulatory actions, and urgent safety communications to healthcare professionals or patients.
• Support regulatory decision-making by contributing to safety assessments, risk management plans, and communications related to emerging safety signals or product restrictions.

This role is ideal for a highly motivated professional with a passion for patient safety, regulatory affairs, and pharmacovigilance excellence. You will thrive in a dynamic environment where your expertise directly impacts the integrity of AbbVie’s global pharmacovigilance framework while driving compliance and innovation in Saudi Arabia.

Join AbbVie and be part of a team that is shaping the future of patient care through unwavering dedication to safety, compliance, and operational excellence.