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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