Genotoxicity Expert

5+ years

Not Disclosed

Hyderabad

10 March 7, 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

Job Title: Genotoxicity Expert

Location: Hyderabad, India
Job Type: Permanent
Posted On: Feb. 12, 2025
Closing On: Mar. 12, 2025

About Sanofi:
Sanofi Consumer Healthcare builds trusted and loved brands that connect with millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities while contributing to a healthier planet. We integrate sustainability into our operations and seek professionals who can help shape the future of our business.

Responsibilities:

Genotoxicity Expertise:

Represent the nonclinical genotoxicity function in multi-functional Genotoxicity Project teams.
Conduct nonclinical identification, selection, and analysis of genotoxicity and safety data for CHC drugs and products.
Search, select, and verify genotoxicity and carcinogenicity studies in internal and external databases.
Identify data gaps and analyze available information for genotoxic classification.
Prepare weight of evidence assessments, including data from genotoxicity studies, SAR, competitor data, and pharmacovigilance reports.
Recommend, subcontract, and supervise additional genotoxicity studies.
Generate concise genotoxicity safety assessments for internal documentation and labeling purposes.
Support, approve, and update labels in collaboration with labeling teams.

Nonclinical Safety Expertise:

Represent the nonclinical safety function in multi-functional teams.
Provide scientifically sound nonclinical safety advice and strategy for CHC products.
Propose, develop, subcontract, and oversee nonclinical studies for product lifecycle management.
Contribute to regulatory documentation, including CTA, CTD, NDA/BLA updates, DSUR, PBRER, and labeling documentation.
Evaluate potential mutagenic impurities in marketed products as per ICH guidelines.
Organize, subcontract, and oversee genotoxicity studies and in silico mutagenicity hazard assessments.
Author concise safety assessments for regulatory submissions.

Main Skills:

Minimum 5 years of experience in nonclinical safety and toxicology, with expertise in genotoxicity.
Strong data gathering, selection, and analytical skills.
Ability to summarize findings and support decisions with evidence.
Knowledge of nonclinical study methodologies, GLP, and regulatory standards.
Familiarity with international regulations, drug development, and regulatory documentation.
Vendor management experience.
Proficiency in toxicology databases and communication software, including Veeva Vault.
Fluent in English.

Pursue Progress. Discover Extraordinary.
Sanofi is committed to fostering an inclusive work environment. We provide equal opportunities to all, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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Genotoxicity Expert

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