Requirements
Candidates must have a degree in Pharmacy (PharmD/BPharm) and 1-2 years of hands-on experience in Pharmacovigilance/Drug Safety within pharmaceuticals. A QPPV training certification and licensure by the Saudi Commission for Health Specialties are required. Proficiency in safety databases, MedDRA coding, and familiarity with safety regulations (SFDA GVP, EMA GVP, ICH) are essential.
Description
Job Title: Patient Safety Senior Officer Department: Patient SafetyReports To: Patient Safety ManagerPosition 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 ResponsibilitiesTriage, 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 regulationsSupport 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 & RequirementsEducation: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 institutionLicensed by Saudi Commission for Health SpecialtiesTechnical 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.