Clinical Study Physician

TCS is hiring for Clinical Study Physician!!!

Job Location – Mumbai

Experience Range – 10 to 15 Years

Educational Qualification(s) Required – MBBS/MD

Roles & Responsibilities

• Literature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion in DSR (Drug Safety reports).

• Provide MAH comments for selected literature o Review of Literature Strategy o Design and interpretation of various types of studies in medicine, levels of evidence, study power for the purpose of safety analyses.

• Thesaurus used for indexing medical scientific literature, relevant for literature search strategy tailoring (both ad-hoc and systematic).

• Review and interpretation of current expert therapeutic guidelines for the purpose of various safety analyses.

• Review of outputs triaged by the safety scientist for scientific accuracy taking into consideration all of the above criteria

• Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER (e. g 5.2.4, 6.2, 9.2, 15 & 16).

Providing MAH comments to literature presented under literature sections. o Authoring of RMP updates & implementation plans

Mumbai

BUSINESS PROCESS SERVICES

Executive

391017

Life Sciences Domain