Clinical Study Physician - Associate - Sr. Manager

4 - 9 years

20 - 27 Lacs

Posted:1 month ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Education

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

Contact Person - Hariharan

Email - hariharan@gojobs.biz

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