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Administracja biurowa » Pracownik biurowy

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UBC - Safety Drug Physician Nr ref.: /JOBS.pl 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:This position is primarily responsible for providing medical support to all operational functions within the Safety Department and supporting the Safety Manager, the Associate Director, and the Executive Director/Director. Specific Job Duties:Ensure that given timelines are met according to project and regulatory timelinesProcess and evaluate AE reports according to the customer's standard operating procedures (SOPs): write/review the narrative, perform seriousness rating and causality assessment Perform medical review of individual cases or safety reportsPerform ICSR signal/trend detectionPerform Aggregate line listing signal/trend detectionReview SAE and AE coding to ensure medical accuracy with the verbatim reported termEnsures medical and scientific input in study protocols and reportsWrite/participate in writing safety reports (RMPs, PSURs, ARs, SBRs, Issue workups, annual reports…)Supervisory Responsibilities:Some mentoring and training of staff required Requirements:Qualified MD, DOAt least 2 years clinical practice experience in drug safety in pharmaceutical, biotech or CRO preferredSome direct clinical research experience is preferred Knowledge of relevant regulation and legislationFluent in English; additional languages a plusExcellent written and verbal communication skillsGood interpersonal and presentation skillsStrong computer skills NO AGENCIES PLEASE Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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