Patient Safety Leader
2 weeks ago
A leading professional in patient safety and regulatory submissions oversees the Global Patient Safety Department, ensuring compliance with ICH-GCP guidelines, regulatory requirements, and standard operating procedures. This role is responsible for leading a global team in all aspects of adverse event data intake and Individual Case Safety Reports (ICSRs) submissions.
Key Responsibilities:- Oversight of processes and systems for adverse event data management
- Reporting of ICSRs to health authorities and partners
- Maintenance of reporting rules in the global safety database
- Expert knowledge of data automation, validation, and analytics tools
- Management of vendors and database configuration
- Contract deliverables and related activities
- Follow-up activities, including questionnaires and routine safety data monitoring measures
- Metric development for intake and reporting compliance
This role requires strong clinical research process knowledge, global pharmacovigilance regulations, and previous people management experience. The ideal candidate will have excellent written and verbal communication skills, organizational abilities, and interpersonal skills. Additionally, they should possess expertise in regulatory affairs, quality assurance, and risk management.
Requirements- Clinical research process knowledge
- Global pharmacovigilance regulations
- Previous people management experience
- Excellent written and verbal communication skills
- Organizational abilities
- Interpersonal skills
- Regulatory affairs expertise
- Quality assurance knowledge
- Risk management skills
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Chief Quality and Patient Safety Officer
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Dublin, Dublin City, Ireland Cpl Healthcare Full timeChief Quality and Patient Safety OfficerKate Cowhig International Recruitment are currently recruiting an experienced Chief Quality and Patient Safety Officer, Dublin, Ireland.For further information & apply please Email your CV toinfo@kcr.ieThe purpose of this role:This is a unique opportunity to shape and lead the strategic direction of quality, clinical...
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Dublin, Dublin City, Ireland National Orthopaedic Hospital Cappagh Full timeHead of Quality, Patient Safety & Risk (QPSR), Grade VIII (Full Time, On Site) | Permanent This newly created position is aimed towards candidates ideally within an acute hospital setting that are familiar with In-patient processes and surgical exposure.Each candidate must have: Between 3-5 years Senior Managerial experience.And A minimum of QQI Level 8...
