Senior Analyst- Toxicology - Bengaluru, India - Evalueserve
Description
Elevate Your Impact Through Innovation and Learning:
Evalueserve is a leading global company that develops innovative and sustainable solutions for a wide range of clients, including more than 30% of the Fortune 500 companies. With a presence in more than 45 countries across five continents, we excel in leveraging state-of-the-art technology, domain-specific AI solutions, and deep subject matter expertise to elevate our clients' strategic decision-making and business impact. Our clients include Amazon, Deutsche Bank, Johnson & Johnson, McDonald's, Microsoft, Morgan Stanley, Nestlé, Novo Nordisk, and Procter & Gamble. We have 4,500+ talented professionals operating across 45 countries, including India, China, Chile, Romania, the US, and Canada. Our global network also extends to emerging markets such as the Middle East and the rest of Asia-Pacific.Recognized by Great Place to Work in India, Chile, Romania, the US, and the UK, we offer a dynamic, growth oriented, and open culture that prioritizes flexible work-life balance, diverse and inclusive teams, and equal opportunities for all.Watch this video to understand what it means to Elevate Your Impact at Evalueserve
Important responsibilities in this role will include:
• Prepare comprehensive Common Technical Document (CTD) dossiers in compliance with international regulations and marketing submission requirements.
• Develop and review reports on Health Based Exposure Limits (HBELs) such as (PDE/ OEL/ ADI) for various chemicals.
• Conduct scientific literature searches to gather, analyze, and compile relevant scientific data from diverse clinical and non-clinical safety, and efficacy databases.
• Evaluate the quality, produce data summaries, and draw conclusions for various toxicological endpoints such as systemic toxicity, genotoxicity, skin/eye irritation, sensitization, carcinogenicity, reproductive toxicity, developmental toxicity, and toxicokinetics, in accordance with guidelines/ guidance established by OECD, ICH, and EPA.
• Review and author hazard or safety assessments for various chemical products such as pharmaceuticals, cosmetics, nutraceuticals, agrochemicals, botanicals, and biomedical devices.
• Draft environmental and ecotoxicity assessments pertaining to chemicals, specifically addressing factors like persistence, bioaccumulation, and toxicity.
Skills we're looking for:
• Proficient in drafting and reviewing non-clinical modules of CTD
• Preparation of HBELs as per regulatory requirements.
• Demonstrate expertise in writing and submitting hazard or safety documentation in compliance with various regulations such as EU, EPA, ICH, or FDA.
• Familiar with a range of toxicology, pharmacology, clinical, and regulatory databases, as well as their search strategies, for the purpose of identifying high-quality data.
• Demonstrates a comprehensive understanding of diverse toxicological studies and their principles in accordance with OECD guidelines.
• Excellent interpersonal skills and effective written and verbal communication abilities.
• Proficient in completing tasks within assigned areas of responsibility with accuracy and timeliness.
• Exhibits attentive and active listening skills.
• Demonstrates strong teamwork skills and logical reasoning.
• Displays the ability to identify proactive approaches to contribute towards the firm's goals and mission.
• Open to challenging existing practices by introducing innovative work methodologies.
• M.Sc, M. Pharmor Ph.D in Toxicology/Regulatory Toxicology.
• A minimum of 4-8 years of professional experience in the chemical, consumer product, or pharmaceutical industry.
• ERT or DABT certification preferred
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