
Clinical Study Physician
7 days ago
Education MBBS/MD/MS
Literature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion in DSR (Drug Safety reports).
Review of Literature Strategy Design and interpretation of various types of studies in medicine, levels of evidence, study power for the purpose of safety analyses.
Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER (e. g 5.2.4, 6.2, 9.2, 15 & 16).
Authoring of RMP updates & implementation plans.
Review of various types of listings for Signal Detection Understanding of signal journey and knowledge of signal management systems and process requirements.
DSR - Complete authoring, Single case analysis & MAH comments, Drafting Overall Conclusion and Review - Must have skillset ICSR Aggregate Reporting Signal Management
Exp.- 4-12yrs
Contact Person - Hariharan
Email -
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7 days ago
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