Patient Safety Senior Officer
Saudi Arabian Japanese Pharmaceutical Company Limited
Jeddah, Makkah Province, Saudi Arabia · Full Time
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- Experience
- 1–2 yrs
- Salary
- —
- Openings
- 1
- Posted
- 4 часа назад
- Work mode
- In office
- Education
- PharmD or BPharm
- Resume
- Required to apply
Where you'll work
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Job description
Role Overview
The Patient Safety Senior Officer position involves overseeing the safety monitoring and management of marketed oncology medications. Due to the complex and high-risk nature of oncology treatments, the role demands expertise in assessing oncological safety profiles, quick adverse event reporting, signal assessment, and adherence to regulatory standards.
Key Duties
- Initial screening, assessment, and review of Individual Case Safety Reports (ICSRs) from clinical studies, spontaneous reports, and post-marketing surveillance.
- Evaluate seriousness, cause, and expectedness of complex oncology-related adverse events.
- Compose detailed medical case narratives and ensure precise MedDRA coding.
- Conduct routine detection of safety signals and analyze safety trends for the oncology product range.
- Assist in preparing and revising Periodic Benefit-Risk Evaluation Reports (PBRERs/PSURs) and Risk Management Plans (RMPs).
- Carry out Risk Minimization Measures (RMM) in compliance with health authority requirements.
- Manage all safety-related correspondences and queries from Health Authorities.
- Ensure consistent compliance with pharmacovigilance regulations.
- Support readiness for audits and inspections related to safety practices.
- Maintain and update Standard Operating Procedures (SOPs) pertinent to safety operations.
- Provide pharmacovigilance training sessions for company personnel as needed.
Qualifications & Expertise
- Academic Background: Degree in Pharmacy (PharmD or BPharm).
- Experience: Between 1 to 2 years in pharmacovigilance or drug safety roles within the pharmaceutical sector.
- Certifications: QPPV training certification from an accredited body and licensure granted by the Saudi Commission for Health Specialties.
- Technical Proficiencies: Practical experience using safety databases; strong skills in MedDRA coding and familiarity with IME list, EURD list; knowledge of causality assessment methodologies like WHO-UMC and Naranjo Algorithm; understanding of relevant regulations including SFDA GVP, EMA GVP, and ICH guidelines.
Personal Attributes
- Strong aptitude for medical writing with meticulous attention to detail.
- Excellent collaborative abilities across functional teams and strong analytical problem-solving skills.