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UBC - Safety Scientist - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

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UBC - Safety Scientist

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  • Since 2003, UBC has been the home for people who are passionate about innovation, service and making a difference in peoples' lives and in the healthcare and biotech industries. 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. And finally, you will enjoy the vast network of resources of our Fortune 20 parent organization, Express Scripts.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. 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 assessmentEnsure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listingsAssist in the reconciliation of clinical and safety databasesMonitor 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 specificationsPerforming global and local literature reviewProject oversight and identification of issues. Escalation. Requirements:Registered Nurse, Pharmacist, or other Life - Science degreeComprehensive knowledge of EU, ICH and FDA Regulations and Guidelines both clinical and post marketingExperience in pre and post marketing Pharmacovigilance Experience in literature reviewExperience in case processing and PV regulatory reporting activitiesExperience in data entry in ICH E2B compliant databaseKnowledge of database management a plus Fluent in English, additional language fluency a plus, but not required*LI-AF1-UBC NO AGENCIES PLEASE


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