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  • Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion Determine seriousness and relatedness across products as ...

  • Able to learn basics of SAS and start SAS Scripting. Extraction of Datasets from various databases to create SAS datasets. SAS Programming and Validation of Final Tables, Listings and Figures (TLFs) Programming and Validation of SAS domains

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