Tata Consultancy Services (TCS) is an IT services, consulting, and business solutions organization that has been partnering with many of the world’s largest businesses in their transformation journeys since its inception in 1968. Our consulting led, innovation-driven services help businesses evolve as perpetually adaptive enterprises, staying ahead in an ever-changing digital landscape. Recognized for excellence in software development, we rapidly apply and scale new technologies, driving long-term value and scalable transformation. Many of these relationships have endured for decades, navigating every technology cycle from mainframes in the 1970s to Artificial Intelligence today.
Post : Clinical Safety Scientist
Job Description
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.)
Candidate Profile
BACHELOR OF PHARMACY, BACHELOR OF SCIENCE (B.Sc Degree ), MASTER OF PHARMACY, MASTER OF SCIENCE
Additional Information
Experience : 5 to 9 Years
Qualification : M.Pharm, B.Pharm, M.Sc, B.Sc
Location : Noida
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 10th January 2026
Clinical Safety Scientist : Apply Online
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