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Safety Scientist Gran Bretaña
- Ref: 2227274
- United Biosource Corporation
- Hace 22 horas
Jornada Completa - Contrato Indefinido - Retribución sin especificar - No se requiere experiencia
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. With the strength of our parent company, Express Scripts, one of largest healthcare companies in North America, UBC leads the market in providing integrated, comprehensive clinical, safety, and commercialization services. Working hand-in-hand with Express Scripts’ specialty pharmacy and specialty distribution organizations, Accredo and CuraScript SD, UBC is uniquely positioned to seamlessly integrate best-in-class services throughout the lifecycle of a product. As a service organization, UBC employees are our greatest resources. Their skills and expertise are what sets us apart in the industry. Working here, you will support the development of life-changing therapies. You will work with peers who will become friends and leaders who listen to your feedback in a collaborative, innovative and fast-paced culture. You will enjoy competitive benefits, pay-for-performance compensation and rewarding recognition that promotes internal quality and critical alignment of our business objectives. With more than 15 locations in North America and Europe, there may be a UBC office close to you.
Duración de la oferta: hasta el 06/01/2018
Brief Description: Responsible for supporting all operational functions within the Safety Department including, but not limited to, client interface and deliverables, Individual Case Safety Report (ICSR) case processing, project start-up, database configuration, literature review, training and contributing to the development and maintenance of departmental Standard Operating Procedures (SOPs) and guidelines. Supervisory Responsibilities: None Specific Job Duties: • Writing of procedural documents such as Adverse Event Reporting Plans (AERPs) • Adverse Event case processing: receipt, data entry, coding, and evaluation of Adverse Event reports according to the applicable SOPs, including writing the narrative; perform seriousness, listedness and causality assessment • Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings • Assist in the reconciliation of clinical and safety databases • Monitor compliance and ensure appropriate documentation (metrics, deviations) • Assist in evaluation and validation of systems to support safety e.g. supporting the development teams in safety database configuration and EDC specifications • Performing global and local literature review • Project oversight and identification of issues. Escalation.
Requirements: • Registered Nurse, Pharmacist, or other Life - Science degree • Comprehensive knowledge of EU, ICH and FDA Regulations and Guidelines both clinical and post marketing • Experience in pre and post marketing Pharmacovigilance • Experience in literature review • Experience in case processing and PV regulatory reporting activities • Experience in data entry in ICH E2B compliant database • Knowledge of database management a plus • Fluent in English, additional language fluency a plus, but not required
Calidad, I+D, PRL y medio ambiente
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