Clinical Safety Scientist

TCS is hiring for Clinical Safety Scientist!!!

Job Location – Noida

Experience Range – 5 to 9 Years

Educational Qualification(s) Required – Any Life Science Graduate

Roles & Responsibilities

Literature:

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

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.

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 ·

Aggregate Reports:

Understanding of safety regulatory report documents in terms of purpose of the different sections, data flow and applicable regulations.

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.

Authoring of RMP updates & implementation plans.

Provides methodology (in collaboration with Roche clinical safety) for data presentation and assessment in the pertinent safety sections of the aggregate report (use outside the indication scope, use in special population, medication errors, characterization of risks etc.)