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UBC - Senior Safety Scientist - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

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UBC - Senior 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, training and contributing to the development and maintenance of departmental Standard Operating Procedures (SOPs) and guidelines. Specific Job Duties:Assist with the preparation of Adverse Event Reporting Plans (AERPs)Alert Project Management when activities fall outside SOWProcess and evaluate Adverse Event reports according to the customer's standard operating procedures (SOPs): write the narrative, perform seriousness rating 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 databasesMedical review of source documents, coding, data entry, report generation and distributionMonitor compliance metrics and ensure appropriate documentation when deficientAssist in evaluation and validation of systems to support safetySupervisory Responsibilities:Lead project teams and assist with new hire decisionsTrain and mentor personnel assigned to project teamsRequirements:Registered Nurse, Pharmacist, or other health care professional degreeComprehensive knowledge of ICH and FDA Regulations and Guidelines both clinical and post marketingExperience in pre and post marketing Pharmacovigilance Experience with case narrative writing for Adverse Event Reports Experience in the review and analysis of the literature outputExperience in PV regulatory reporting activitiesKnowledge of database management and use of coding dictionariesFluent in English, additional language fluency a plus, but not required*LI-AF1-UBCNO AGENCIES PLEASE


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