Senior Analyst - Toxicology

Evalueserve, Inc.; Bengaluru; On-site; INR 1,200,000 - 1,600,000; Full time

Job summary

Evalueserve, Inc. in Bengaluru seeks an experienced Toxicologist to ensure GLP/OECD/ICh/EPA framework compliance, review study plans, amendments, and pathology audits, and support regulatory documentation.

The role includes drafting CTD dossiers, evaluating HBELs for various chemicals, and performing literature searches to compile toxicology data across endpoints. Strong regulatory writing and communication skills are essential.

Qualifications

• Masters degree in pharmacy, pharmacology or toxicology with 3–5 years of relevant experience.
• Experience drafting and reviewing non-clinical CTD modules and regulatory documents.
• Proven ability to prepare HBELs (PDE/OEL/ADI) in compliance with regulatory requirements.
• Strong regulatory writing, data analysis and attention to detail; knowledge of OECD/ICh/EPA guidelines.

Responsibilities

• Prepare comprehensive CTD dossiers in line with international regulations and submission requirements.
• Develop and review HBELs (PDE/OEL/ADI) for various chemicals.
• Conduct literature searches to gather and analyze safety data from diverse databases.
• Evaluate toxicology endpoints (systemic toxicity, genotoxicity, irritation, carcinogenicity, reproductive and developmental toxicity, toxicokinetics).
• Draft environmental and ecotoxicity assessments addressing persistence, bioaccumulation and toxicity.

Skills

Toxicology

Regulatory compliance

Literature review

Technical writing

Quality assurance

Education

Master's degree in Pharmacy, Pharmacology or Toxicology

Job description

Job Summary

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 Toxicology with 3 to 5 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.