Role Accountabilities

•    Conduct literature searches and prepare toxicological assessments of various raw materials/ingredients/API/ Pharmaceuticals used in consumer and OTC products.
•    Preparation and reviewing of Nonclinical overview for CTD submission of dossier filing.
•    Creation of Toxicology Profiles for INCI ingredients as well as residual chemicals.
•    Conduct risk assessment for raw materials for cosmetic applications including Margin of safety calculations.
•    To derive Health Based exposure limit (PDE/OEL/DNEL/ADI) for Pharmaceuticals/ cosmetics/ nutraceuticals/ agrochemicals/ botanicals.
•    To provide evidence of efficacy and safety (preclinical and clinical) as per regulatory requirements.
•    Preparation of Safety Data sheet in compliance with GHS.
•    Scientific literature search-To extract, analyze and collate toxicology data from various clinical/toxicology/efficacy related databases like TOXNET, HSDB, PubMed, Medline, ScienceDirect etc. 
•    To evaluate quality of different toxicity studies (such as systemic toxicity, genotoxicity, skin/eye irritation, sensitization, carcinogenicity, reproductive and developmental toxicity, toxicokinetic studies) as per OECD/ ICH /FDA/ISO guidelines.
•    To prepare research reports/ dossiers according to the international regulatory guidelines.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•     Excellence
•     Integrity
•     Professionalism

Experience

•    1-3 Years

Skills and Capabilities
•    Conduct literature searches and prepare toxicological assessments of various raw materials/ingredients/API/ Pharmaceuticals used in consumer and OTC products.
•    Preparation and reviewing of Nonclinical overview for CTD submission of dossier filing.
•    Creation of Toxicology Profiles for INCI ingredients as well as residual chemicals.
•    Conduct risk assessment for raw materials for cosmetic applications including Margin of safety calculations
•    To derive Health Based exposure limit (PDE/OEL/DNEL/ADI) for Pharmaceuticals/ cosmetics/ nutraceuticals/ agrochemicals/ botanicals
•    To provide evidence of efficacy and safety (preclinical and clinical) as per regulatory requirements 
•    Preparation of Safety Data sheet in compliance with GHS
•    Scientific literature search -To extract, analyze and collate toxicology data from various clinical/toxicology/efficacy related databases like TOXNET, HSDB, PubMed, Medline, ScienceDirect etc. 
•    To evaluate quality of different toxicity studies (such as systemic toxicity, genotoxicity, skin/eye irritation, sensitization, carcinogenicity, reprotoxicity and developmental, toxicokinetics studies) as per OECD/ ICH /FDA/ISO guidelines 
•    To prepare research reports/ dossiers according to the international regulatory guidelines

Education 

•    MSc/MPharm/MVSc

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