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255 Sanofi Jobs
Genotoxicity Expert
Sanofi
posted 17hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Provide nonclinical genotoxicity expertise for CHC drugs and marketed products including:
- Representing the nonclinical genotoxicity function in multi-functional Genotoxicity Project team.
- Responsibility for the scientifically sound nonclinical identification, selection and analysis of genotoxicity and other safety data pertaining to CHC drugs and products to evaluate and categorize the genotoxic potential.
- Searching, selection and identification of studies ( mainly genotoxicity and carcinogenicity) and data in internal and external databases,
- Verification of results and identification of gaps to support classification for further steps,
- Searching for information on labelling,
- Identification of data gaps,
- Verification of validity of the data and studies,
- Analysis of all data and classification,
- Additional data search, thorough study reviews,
- Prepare and support weight of evidence (with help from pharmacovigilance and labelling) and MRPTC/SMC presentations,
- For weight of evidence, need to analyse data from:
- Genotoxicity studies, structure activity relationships, data from structurally related drugs/competitors, carcinogenicity/genotoxicity data, clinical trial and PV data, labelling data from structurally related drugs/competitors,
- Recommend, subcontract and supervise additional genotoxicity studies,
- Generating concise genotoxicity safety assessments for internal documentation and use, and for labelling purposes ( e.g. Amendments to Non-Clinical Overview, Safety Evaluation Reports, one-page summaries ),
- Support, agree and update/approve labels in collaboration with labelling teams.
- Provide nonclinical safety expertise for CHC projects, marketed products and Industrial Affairs including:
- Representing the nonclinical safety function in multi-functional teams.
- Analysis and proposal of scientifically sound nonclinical safety advice/strategy on safety issues concerning CHC products.
- Responsibility for the proposal, development, subcontracting and oversight of non-clinical studies aligned with project/product phases (from clinical study initiation to registration and life cycle management).
- Contributing to the preparation of regulatory documentation as CTA, CTD, Marketing Authorization renewal, NDA/BLA annual update, DSUR, PBRER, and labelling documentation. This includes all nonclinical documents requested to support dossier submission (e.g., nonclinical overview), to be part of life cycle management, to be requested by HA).
- Generating concise safety assessments for internal decision making, as well as regulatory submission documentation to facilitate health authority reviews and approval processes in all phases of drug development and life cycle management.
- Providing nonclinical safety expertise for the evaluation of potential [mutagenic] impurities in marketed products according to ICH guidelines ( mainly ICH M7 but also ICH Q3A/B), and in accordance with company policy.
- Organizing, subcontracting and oversight of appropriate genotoxicity studies and in silico mutagenicity hazard assessments,
- Contributing to the preparation of internal (investigation report) and regulatory submitted documentation (Health Hazard Evaluation) by authoring concise safety assessments on potential mutagenic impurities, impurity qualification.
- Main skills:
- Nonclinical safety and toxicology experience (5 years), with extensive knowledge of genotoxicity studies,
- Ability to gather, select and analyse data and make informed decisions,
- Ability to summarise and present findings, and to defend and support decisions,
- Methodology of nonclinical studies,
- GLP, quality/analytical mindset,
- Willingness to learn and co-operate,
- Interpersonal relationships - treating others with courtesy, sensitivity, and respect,
- Knowledge of international regulations, guidelines, standards and SOPs pertaining to the pharmaceutical industry: nonclinical studies (genotoxicity), drug development and regulatory submissions and documentation,
- Vendor management,
- Computer literate, knowledge of key toxicology databases and editing / presentation / communication software, including Veeva Vault,
- Fluent in English.
Employment Type: Full Time, Permanent
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Expert salary at Sanofi
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employees
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₹24.1
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L/yr
97%
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Flexible timing
Monday to Friday
Within city
Day Shift
Sanofi Benefits
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