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Genotoxicity Expert

2+ years
Not Disclosed
10 March 31, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Genotoxicity Expert - 


Location:

Hyderabad, India

Job Type:

Permanent

Posted On:

March 28, 2025

Expires On:

April 07, 2025


About Sanofi Consumer Healthcare:

Sanofi Consumer Healthcare (CHC) builds trusted brands that connect with millions of consumers worldwide. Our mission is to enable better self-care while contributing to a healthier planet. We aim to act responsibly from a social and environmental perspective and need talented individuals who can shape the future of our business to become the best fast-moving consumer healthcare company globally.


Responsibilities:

  • Genotoxicity Expertise:

    • Provide nonclinical genotoxicity expertise for CHC drugs and marketed products.

    • Represent the nonclinical genotoxicity function in multi-functional Genotoxicity Project teams.

    • Ensure scientifically sound evaluation and categorization of genotoxic potential of CHC products.

  • Data Analysis & Classification:

    • Search, select, and identify relevant genotoxicity and carcinogenicity studies and data.

    • Verify results, identify gaps, and analyze data for accurate classification.

    • Conduct thorough study reviews and support weight of evidence assessments.

  • Documentation & Reporting:

    • Generate concise genotoxicity safety assessments for internal documentation and labeling.

    • Support the preparation of MRPTC/SMC presentations.

  • Supervision of Studies:

    • Recommend, subcontract, and supervise additional genotoxicity studies as needed.

  • Data Verification & Gap Analysis:

    • Search for information on labeling and verify the validity of data and studies.

    • Identify and address data gaps to ensure comprehensive safety evaluations.


Weight of Evidence Analysis:

  • Analyze data from:

    • Genotoxicity studies and structure-activity relationships.

    • Data from structurally related drugs/competitors.

    • Carcinogenicity/genotoxicity data.

    • Clinical trial and pharmacovigilance (PV) data.

    • Labeling data from structurally related drugs/competitors.


Why Join Us?

  • Inclusive Culture: Sanofi fosters an inclusive environment where diversity is valued, and employees feel supported.

  • Work-Life Balance: Flexible working hours and remote work options to maintain professional and personal balance.

  • Career Development: Opportunities for mentorship, career growth, and professional development.

  • Supportive Environment: Collaboration, innovation, and continuous learning are at the core of our values.


Qualifications:

  • Education:

    • Bachelor’s or Master’s degree in a relevant scientific discipline.

    • Ph.D. preferred in toxicology, pharmacology, or related fields.

  • Experience:

    • Extensive experience in genotoxicity evaluation, preferably in the pharmaceutical or consumer healthcare industry.

    • Strong understanding of genotoxicity assays, data interpretation, and regulatory guidelines.

    • Demonstrated ability to conduct gap analyses and provide scientifically sound recommendations.

  • Technical Skills:

    • Proficiency in analyzing genotoxicity and carcinogenicity data.

    • Experience with regulatory frameworks and safety assessments.


About Sanofi:

Sanofi believes in equal opportunities for all, regardless of background, ethnicity, gender, orientation, or abilities. Join us in our mission to make the impossible possible and contribute to a healthier world.

Learn More: sanofi.com