Consultant - Toxicology

Evalueserve; Bengaluru; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Evalueserve, Inc. seeks an experienced Toxicologist in Bengaluru to ensure GLP and OECD/IHC/EPA regulatory compliance. You will prepare CTD dossiers, review HBELs, and contribute to study plan reviews and pathology audits.

You will perform literature searches, evaluate toxicology endpoints, draft environmental assessments, and maintain high standards of scientific documentation for regulatory submissions. Strong communication and teamwork are essential to meet client expectations and firm goals.

Qualifications

• 8–12 years of experience in toxicology or a related field.
• Proficient in drafting and reviewing non-clinical CTD modules.
• HBELs preparation per regulatory requirements.
• Experience with hazard/safety documentation per EU, EPA, ICH, FDA.
• Familiar with toxicology databases and search strategies.
• Strong communication and teamwork skills.

Responsibilities

• Prepare comprehensive Common Technical Document (CTD) dossiers in compliance with international regulations.
• Develop and review reports on Health Based Exposure Limits (HBELs) for various chemicals.
• Conduct scientific literature searches to gather and analyze data from diverse safety databases.
• Evaluate quality, produce data summaries, and draw conclusions for toxicological endpoints per OECD/ICH/EPA guidance.
• Draft environmental and ecotoxicity assessments addressing persistence, bioaccumulation and toxicity.

Skills

CTD drafting

HBELs preparation

Regulatory writing

Client interaction

OECD guidelines

Toxicology databases

Teamwork

Communication skills

Regulatory compliance

Education

Masters degree in pharmacy, Pharmacology or Toxicology

Job description

We are seeking an experienced Toxicologist with expertise in OECD guidelines and risk assessment. The ideal candidate will ensure full compliance with GLP, OECD, ICH, IAEC, and institutional standards, actively participate in study plan reviews, protocol amendments, and pathology audits, and support regulatory documentation. Strong attention to detail and knowledge of regulatory frameworks are essential.

Key Responsibilities:

• 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.
• Draft environmental and ecotoxicity assessments pertaining to chemicals, specifically addressing factors like persistence, bioaccumulation, and toxicity.

Core Competencies:

• Masters degree in pharmacy, Pharmacology or To xicology with 8 to 12 Years of experience in relevant field.
• Proficient in drafting and reviewing non-clinical modules of CTD.
• Preparation of HBELs as per regulatory requirements.
• Regular client interactions and understanding the requirements and deliver the project.
• Demonstrated 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.