Require Study Director and Regulatory Toxicologist at Syngene

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Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities.

Post : Study Director and Regulatory Toxicologist

Job Description
• Conduct of Non-clinical toxicity studies based on Organization for Economic Co-operation and Development (OECD)/Food and Drug Administration (FDA)/Environmental Protection Agency (EPA)/ International Organization for Standardization (ISO) guidelines.
• Conduct literature searches and prepare toxicological assessments report of various raw materials/ ingredients/Active pharmaceutical ingredients/Pharmaceuticals used in various products.
• Scientific literature search -To extract, analyze and collate toxicology data from various clinical/toxicology/efficacy related databases like, PubMed, Medline, ScienceDirect, FDA, clinicaltrails.gov etc.
• Creation of Toxicology Profiles for International Nomenclature of Cosmetic Ingredients (INCI) 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 [Permitted daily exposure (PDE)/Occupational exposure limit (OEL)/ derived No effect level (DNEL)/ acceptable daily intake (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 Globally Harmonized System.
• To evaluate quality of different toxicity studies (such as systemic toxicity, genotoxicity, skin/eye irritation, sensitization, carcinogenicity, reproductive and developmental toxicity, Toxicokinetics studies) as per international guidelines.
• To prepare research reports/ dossiers according to the international regulatory guidelines.

Candidate Profile
• MVSc / M.Pharm / MS Pharm / MSc - Pharmacology / Toxicology / Regulatory Toxicology / Zoology
• 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)/Food and Drug Administration (FDA)/Environmental Protection Agency(EPA)/ International Organization for Standardization (ISO ) guidelines for toxicity studies.
• 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
• Should be able to interpret toxicological data
• Ability to ensure that tasks within areas of responsibility are completed accurately in a timely manner
• Participate in Process Improvement Initiatives to keep up the Quality and Compliance score
• Complete all assigned trainings within specified timelines
• 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

Additional Information
Qualification :  B.Sc. / M.Sc. / B.V.Sc. / M.V. Sc / M. Pharm
Experience :
1-5 years
Industry Type : Pharma / Healthcare / Clinical research
Job ID : 11124
End Date : 30th June, 2020

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