Descrição
Efficiency in conducting literature searches for authoring various types of reports
Author/review various safety reports for global regulatory submissions for Lab Corp clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents as assigned.
Author RMP, perform Signal detection activities
Author/ review ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports
Perform allied activities like: Generation of line listings and summary tabulation, CFIs CFCs
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