Clinical Safety Scientist

1 week ago

Bengaluru Chennai Noida, India Tata Consultancy Services Full time ₹ 6,00,000 - ₹ 15,00,000 per year

TCS is Hiring -Clinical Safety Scientist

location - Mumbai, Noida, Bengaluru

Experience Range - 5 to 10

Preferred Educational Qualification for the role - Any life science Graduate

Job Description

Literature Review

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:

Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER.

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.)

Asses the new information received on important safety concerns for the medicinal product.

Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy

Signal Management

Review of various types of listings for Signal Detection

Understanding of signal journey and knowledge of signal management systems and process requirements.

Perform Signal validation with a brief summary.

DSR - Complete authoring, Single case analysis & MAH comments, Drafting Overall Conclusion and Review

Tailoring strategy and methodology for signal assessment

Overall assessment of the signal based on the presented data and respective recommendation for action

Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy

Interested Candidate can mail on -

Regards,

Laharika-TCS HR

  • Scientist, Clinical Trial Safety

    2 days ago

    Bengaluru, India AstraZeneca Full time

    **JOB TITLE : Scientist I, Clinical Trial Safety**: **CAREER LEVEL: C** **Leverage technology to impact patients and ultimately save lives**: **About astrazeneca**: AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the...

  • Clinical Safety Physician

    2 weeks ago

    Bengaluru, Mumbai, Noida, India Tata Consultancy Services Full time ₹ 8,00,000 - ₹ 20,00,000 per year

    TCS is Hiring -Clinical Safety Physicianlocation - Mumbai, Noida, BengaluruExperience Range - 5 to 10Preferred Educational Qualification for the role - MBBS/MDJob DescriptionLiterature ReviewLiterature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion in DSR (Drug Safety reports).Provide MAH comments for selected...

  • Data Scientist

    2 days ago

    Bengaluru, Karnataka, India WCG Clinical Full time ₹ 80,00,000 - ₹ 2,00,00,000 per year

    Description and RequirementsJOB SUMMARY: In our Data & Analytics (D&A) organization, the Data Scientist plays a pivotal role in the development of analytics-driven solutions that optimize and streamline end-to-end clinical trial processes. Working closely with our D&A engineering team and clinical trial experts, this role will harness the power of...

  • Clinical Research Coordinator

    6 days ago

    Domlur, Bengaluru, Karnataka, India MS CLINICAL Full time

    **Job Title**: Clinical Research Coordinator (minimum 1 year of experience)** **Company**: MS Clinical Research Pvt Ltd** **About Us**: MS Clinical Research (MSCR) is a dynamic and forward-thinking clinical research organization dedicated to conducting cutting-edge clinical trials. We are committed to advancing medical science and contributing to the...

  • Senior Clinical Research Associate

    4 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Senior Clinical Research Associate (Sr. CRA) Company: MS Clinical Research Pvt Ltd Experience: Minimum 5 years About Us MS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of...

  • Senior Clinical Research Associate

    4 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Senior Clinical Research Associate (Sr. CRA) Company: MS Clinical Research Pvt Ltd Experience: Minimum 5 years About Us MS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of...

  • Senior Clinical Research Associate

    2 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Senior Clinical Research Associate (Sr. CRA) Company: MS Clinical Research Pvt Ltd Experience: Minimum 5 years About Us MS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of...

  • Clinical Data Scientist

    2 weeks ago

    Bengaluru, Karnataka, India Axtria - Ingenious Insights Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Core Responsibilities:As a Clinical Data Scientist, you will independently perform data analysis, data mining on various clinical trial data sources. You will develop, test, productionize and maintain AI/ML/GenAI models. You will leverage cloud-based solutions for scalable data processing and collaborate with cross-functional teams to deliver cutting edge...

  • Senior Clinical Research Associate

    4 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Senior Clinical Research Associate (Sr. CRA)Company: MS Clinical Research Pvt LtdExperience: Minimum 5 yearsAbout UsMS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of...

  • Senior Clinical Research Associate

    4 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Senior Clinical Research Associate (Sr. CRA)Company: MS Clinical Research Pvt LtdExperience: Minimum 5 yearsAbout UsMS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of...