Overview
Patient Safety Senior Officer Jobs in Jeddah, Saudi Arabia at ساجا الصيدلانية
- Job Title: Patient Safety Senior Officer
- Department: Patient Safety
- Reports To: Patient Safety Manager
Position Overview: The Patient Safety Senior Officer is responsible for monitoring, evaluating, and managing the safety profile marketed oncology products. Given the risk-benefit profiles and high toxicity inherent to oncology treatments, this role requires an understanding of oncological safety profiles, expedited adverse event reporting, signal management, and applicable regulatory compliance.
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 RMM adequately and according to HA requirements.
- Handle all communications and safety-related queries raised by Health Authorities.
- Ensure strict adherence to applicable PV regulations
- Support audit and inspection readiness for safety operations.
- Maintain and update Standard Operating Procedures (SOPs).
- Conduct the PV training for the company staff as required.
Qualifications & Requirements
- Education:
Degree in Pharmacy (PharmD/BPharm)
- Experience:
1-2 years of hands-on experience in Pharmacovigilance / Drug Safety within pharmaceuticals.
License/
Certifications:
- QPPV training Certification from a recognized institution
- Licensed by Saudi Commission for Health Specialties
Technical
Skills:
- Hands-on experience with safety databases
- Strong working knowledge of MedDRA coding, IME list, EURD list, WHO-UMC & Naranjo Algorithm for causality assessment.
- Familiarity with safety regulations (SFDA GVP, EMA GVP & ICH).
Soft Skills:
- – Strong medical writing abilities and attention to detail.
- – Excellent cross-functional collaboration and analytical problem-solving skills.
Title: Patient Safety Senior Officer
Company: ساجا الصيدلانية
Location: Jeddah, Saudi Arabia
Category: