Pharmacovigilance Specialist - NQPPV Backup

AbbVie Inc.; Riyadh; On-site; SAR 180,000 - 260,000; Full time

Job summary

AbbVie Inc. in Saudi Arabia is seeking a Pharmacovigilance Specialist to coordinate affiliate PV activities and back up the National QPPV Deputy role.

The role ensures regulatory compliance, maintains a robust PV system, and serves as the local contact for the Saudi health authority on safety matters. You will support oversight of PV processes, lead safety reporting, and collaborate with regional teams to sustain compliance with Saudi GVP and AbbVie standards, while communicating efficiently in

Qualifications

• Bachelor's degree in pharmacy or medicine is required.
• Meets Saudi health authority eligibility, professional registration, location, notification and training requirements for the National QPPV Deputy at appointment time.
• At least two years of experience in the pharmaceutical industry in a pharmacovigilance role is required.
• Knowledge of pharmacovigilance activities and operation of a pharmacovigilance system.
• Fluency in English and Arabic is required for communication within the affiliate and with Saudi health authority.

Responsibilities

• Coordinate and execute affiliate pharmacovigilance activities in Saudi Arabia.
• Act as local pharmacovigilance contact point for the Saudi health authority on a 24-hour basis.
• Develop, implement and maintain local pharmacovigilance procedures in line with AbbVie corporate procedures and Saudi requirements.
• Ensure timely submission of safety reports and support safety communications as applicable.

Skills

Pharmacovigilance experience

Attention to detail

Education

Bachelor's degree in pharmacy or medicine

Job description

Job Summary

The Pharmacovigilance Specialist supports the Affiliate Safety Representative and Regional Pharmacovigilance Lead in coordinating and executing affiliate pharmacovigilance activities in Saudi Arabia The role helps ensure that AbbVie meets its legal regulatory quality and ethical responsibilities for patient safety and maintains an effective local pharmacovigilance system The role serves as Back‑up Affiliate Safety Representative and Saudi Arabia National Qualified Person for Pharmacovigilance Deputy The incumbent maintains continuous readiness to act for the National QPPV and assumes delegated or back‑up responsibilities when required The role has sufficient access authority and escalation channels to influence the performance of the pharmacovigilance quality system support compliance with Saudi Good Pharmacovigilance Practice requirements and act as a pharmacovigilance contact for the Saudi health authority and AbbVie Global Patient Safety Primary Accountabilities

National QPPV Deputy and Regulatory Accountability

Maintain the knowledge training access and availability required to fulfil the National QPPV Deputy role in accordance with Saudi regulations AbbVie procedures and the approved country attestation or delegation documentation Act for the National QPPV when formally delegated or when back‑up coverage is activated and support the National QPPV in maintaining oversight of the local pharmacovigilance system at all other times Serve as required as a single local pharmacovigilance contact point for the Saudi health authority on a 24-hour basis and as a contact point for pharmacovigilance inspections Remain permanently and continuously reachable in line with applicable local requirements approved back‑up arrangements and the affiliate business continuity plan Maintain sufficient authority to influence the pharmacovigilance quality system and to promote maintain and improve compliance with applicable legal and regulatory requirements Ensure that delegated National QPPV activities back‑up arrangements and access to relevant medical expertise are clearly documented and kept current Provide full and prompt responses to health authority requests for information required to evaluate the benefit‑risk profile of a medicinal product Provide input into regulatory actions arising from emerging safety concerns including urgent safety restrictions and communications to healthcare professionals or patients as applicable

Oversight of the Pharmacovigilance System

Support oversight of the performance and functioning of the local pharmacovigilance system 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 and support confirmation that information relating to Saudi Arabia is accurate complete and current Review local pharmacovigilance activity metrics and compliance indicators Identify risks elevate issues promptly and track agreed actions to completion Maintain awareness of the validation status and significant changes to relevant safety databases including failures identified during validation and the corrective actions taken where applicable Collaborate with Regional Pharmacovigilance teams to provide the metrics records and supporting information needed by the Affiliate Safety Representative and National QPPV to demonstrate system oversight 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

Quality Management System and Procedures

Develop implement and maintain local pharmacovigilance procedures in line with AbbVie corporate procedures Saudi regulatory requirements and the local operating model Ensure that local procedures adequately address back‑up and delegation training local individual case safety reports medical assessment support seriousness and causality assessment local literature screening national pharmacovigilance system files risk minimization measures signal management safety variations and periodic or aggregate reporting as applicable Manage non‑conformities and planned departures from corporate or local pharmacovigilance procedures through the applicable global issue and exception management process Support the development implementation and timely completion of corrective and preventive actions Maintain controlled records that demonstrate compliance with local requirements and AbbVie procedures

Adverse Events and Safety Reporting

Support processes for the intake processing translation follow‑up medical assessment support and reconciliation of adverse events and other safety information from spontaneous reports solicited programs clinical studies product complaints and other reportable sources Partner with Regional Pharmacovigilance teams to ensure timely submission of clinical and post‑marketing individual case safety reports to the Saudi health authority ethics committees and investigators as required Support the production review and submission of periodic and aggregate safety reports including periodic safety update reports periodic benefit‑risk evaluation reports and development safety update reports as applicable Help ensure that pharmacovigilance data submitted to health authorities are correct complete traceable and submitted within applicable timelines Support reconciliation of safety data with product complaints medical information organized data collection programs and other identified sources

Qualifications and Experience

Bachelor's degree in pharmacy or medicine is required. Meets all current Saudi health authority eligibility, professional registration, location, notification and training requirements applicable to the National QPPV Deputy designation at the time of appointment. At least two years of experience in the pharmaceutical industry in a pharmacovigilance role is required. Documented theoretical and practical knowledge of pharmacovigilance activities and the operation of a pharmacovigilance system. Demonstrated experience with adverse event and individual case safety report processes, periodic or aggregate reporting, risk management, pharmacovigilance quality systems, training, audits or inspections and regulatory compliance. Sound knowledge of Saudi pharmacovigilance legislation, Saudi Good Pharmacovigilance Practice requirements and applicable regional or global pharmacovigilance standards. Documented training sufficient to oversee and support maintenance of an effective local pharmacovigilance system. Any additional training mandated by the Saudi health authority must be completed and maintained. Ability to understand product safety profiles, emerging safety concerns, benefit‑risk information and the scientific basis of risk management decisions. Fluency in written and spoken English is essential for communication with Global Patient Safety, regional teams and global functions. Fluency in written and spoken Arabic is required for communication within the affiliate and with the Saudi health authority. Excellent written and verbal communication and presentation skills. Strong planning, organization and prioritization skills, with the ability to manage multiple time‑sensitive regulatory obligations. Sound judgment, attention to detail and a demonstrated sense of urgency in managing safety and compliance matters. Strong scientific acumen and the ability to understand and apply scientific and regulatory concepts.