Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.
Post : Associate Scientist – Regulatory Toxicologist
• Conduct literature searches and prepare toxicological assessments of various raw materials/ingredients/Active Pharmaceutical Ingredients (API) Pharmaceuticals used in consumer and Over the Counter (OTC) products.
• Creation of toxicology profiles for The International Nomenclature of Cosmetic Ingredients (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 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 Globally Harmonized System of Classification and Labeling of. Chemicals (GHS).
• Should be familiar with NCO, PBRER, PLLR documents
• Scientific literature searches - To extract, analyze and collate toxicology data from various clinical/toxicology/efficacy related databases like Toxicology Data Network (TOXNET), Hazardous Substances Data Bank (HSDB), PubMed, Medline, ScienceDirect etc.
• To evaluate quality of different toxicity studies (such as systemic toxicity, Geno-toxicity, skin/eye irritation, sensitization, carcinogenicity, repro-toxicity and developmental, toxico-kinetics studies) as per Organization for Economic Co-operation and Development (OECD)/ International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) / Food and Drug Administration (FDA)/ International Organization for Standardization (ISO) guidelines.
• To prepare research reports/ dossiers according to the international regulatory guidelines.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
• M. Pharm/M. Sc/M. Vsc
• Thorough understanding of various toxicological studies and their principles and Endpoints.
• Capability of interpretation of results and analysis of key toxicity data.
• Knowledge of Organization for Economic Co-operation and Development (OECD)/ International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) / Food and Drug Administration (FDA)/ International Organization for Standardization (ISO) guidelines for preclinical toxicity studies.
• Knowledge of various toxicology/ pharmacology/ clinical/ regulatory databases like TOXNET, ECOTOX, PubMed, e-Chemportal, clinicaltrails.gov, EFSA etc
• Basic knowledge of clinical trials
• Basic knowledge of eco/environmental toxicity (e.g. biodegradation, toxicity to daphnia, fish (acute and chronic), toxicity to algae)
• Knowledge of dose calculation/conversion
• Attend training on environment, health, and safety (EHS) measures imparted company
• At least 5 years of relevant Regulatory Toxicologist experience
• Good interpersonal skills and communication (both written and verbal) skills
• Ability to ensure that tasks within areas of responsibility are completed accurately in a timely manner
• Ability to practice attentive and active listening skills
• Act as an efficient team player with good reasoning.
• Ability to identify pro-active ways to contribute to firms goals & mission.
• Challenging current thinking by implementing new ways of working
Experience : 10-14 years
Qualification : .Pharm / B.Pharm / M.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Corporate Quality Assurance
End Date : 30th December, 2020
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