About the Saudi Arabian Japanese Pharmaceutical Company

The Saudi Arabian Japanese Pharmaceutical Company is a key player in the pharmaceutical sector, committed to patient safety and regulatory excellence. We are currently seeking a dedicated Patient Safety Senior Officer to join our team in Jeddah, Makkah, Saudi Arabia.

Role Summary

This full-time position involves the critical responsibility of monitoring, evaluating, and managing the safety profile of marketed oncology products. The role demands a deep understanding of oncological safety, expedited adverse event reporting, signal management, and strict adherence to applicable regulatory compliance, recognizing the complex risk-benefit profiles and high toxicity inherent to oncology treatments.

Key Responsibilities

• Triage, review, and evaluate Individual Case Safety Reports (ICSRs) from studies, spontaneous reporting, and post-marketing surveillance.
• Assess case seriousness, causality, and expectedness (listedness) for complex oncology adverse events.
• Draft medical narratives and ensure accurate MedDRA coding.
• Perform routine signal detection and safety trend analyses across oncology product portfolios.
• Contribute to the drafting and updating of Periodic Benefit-Risk Evaluation Reports (PBRERs/PSURs), and Risk Management Plans (RMPs).
• Perform all related Risk Minimization Measures (RMM) adequately and according to Health Authority (HA) requirements.
• Handle all communications and safety-related queries raised by Health Authorities.
• Ensure strict adherence to applicable Pharmacovigilance (PV) regulations.
• Support audit and inspection readiness for safety operations.
• Maintain and update Standard Operating Procedures (SOPs).
• Conduct PV training for the company staff as required.

Required Qualifications and Experience

Candidates for this role should possess 2 to 5 years of experience in a relevant patient safety or pharmacovigilance capacity, preferably within the pharmaceutical industry and with exposure to oncology products.

Work Type and Location

This is a full-time position based at our facilities in Jeddah, Makkah, Saudi Arabia. The role operates within a structured environment dedicated to upholding the highest standards of pharmaceutical safety.

Application Process

We encourage qualified professionals who meet the outlined requirements to apply and contribute to our commitment to patient safety.