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
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