وظيفة أخصائي سلامة المرضى أول لدى Saudi Arabian Japanese Pharmaceutical Company Limited بمكة جدة

• 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.