[New Job Opening] Jr. Drug Safety Associate job Vacancy in Somerset, NJ 08873


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Job Details:
Position Name :
Jr. Drug Safety Associate
Somerset, NJ 08873
Job ID :
Description : Expericne required 0-3 Years. Training will be provided for Junior level positions.Apply safety concepts and regulations contained within FDA CFR, ICH, and EU GVP to management of Safety data across the development life cycleAnalyze aggregate safety data within a clinical program towards tracking and trending of risk assessments and additional mitigation measuresIdentify potential signals and escalate to the medical review functionGather and analyze safety data for escalation to the Executive Safety Advisory CommitteeFacilitate deliverables using strong project management/time managementContribute to safety sections of the investigational new drug and new drug applications, investigator or regulator communications, Investigator brochure, and other reports (DSUR)Participate in the set-up and maintenance of adverse event processes in global clinical trialsPerform Quality Review of the Individual Case Safety Report, including data and a concise, medically relevant narrativeObtain clinically meaningful information from investigators to provide a robust safety assessmentCreate and/or contribute to SOP development and “plan” documents within a clinical trialDevelop electronic case report forms, configure the Clinical database for Safety specifications, perform User Acceptance Testing, maintain documentation, and perform reconciliation with the clinical trial dataAct as a liaison internally and externally (e.g., Clinical Development, Regulatory Affairs, Biometrics, parent company and business partners) to develop programs and processesJob Type: Full-timePay: $65,000.00 – $100,000.00 per yearSchedule:Day shiftWork Location: One location
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