Wednesday, November 25, 2020

SYNGENE Career Opportunities: Regulatory Toxicologist M. Pharm/M. Sc/M. Vsc Apply Now

SYNGENE Career Opportunities: Regulatory Toxicologist M. Pharm/M. Sc/M. Vsc Apply Now


About Syngene

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.

Job Role: The role will serve as the project team member on multidisciplinary research and development teams, being responsible for design, reporting, and interpretation of regulatory nonclinical safety studies.

Key Responsibilities:

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

Educational Qualification:

M. Pharm/M. Sc/M. Vsc

Technical/functional Skills:

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

Experience:

At least 5 years of relevant Regulatory Toxicologist experience


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