Require Study Director and Regulatory Toxicologist at Syngene

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