Job Description

Job Title: Senior Toxicologist (SME) - Risk Assessment
Location: Unit 2, Shamirpet
Job Type: Full-Time
Reports To: Director, Toxicology

Position Summary:

We are seeking an experienced Senior Toxicologist to lead and execute human health risk assessments with a focus on preparing Permitted Daily Exposure (PDE) and Occupational Exposure Limit (OEL) reports. This role also includes design of exploratory study designs, review of in vivo toxicology data and preparation of toxicology reports. This role requires expert knowledge of toxicological principles, regulatory guidelines, and strong communication skills for effective client interactions and internal training responsibilities.

Key Responsibilities:

1. Risk Assessment & Report Preparation
Independently conduct and peer-review risk assessments for pharmaceutical and industrial chemicals.

Prepare high-quality PDE and OEL reports in accordance with global regulatory guidance (e.g., ICH Q3C, Q3D, EMA, FDA, REACH).

Analyze toxicological data from scientific literature, databases, and regulatory sources.

2. Client Communication and commercial support
Act as the primary toxicology expert in client discussions.

Present findings, explain methodologies, and address technical questions in a clear and professional manner.

Collaborate with project managers and QA teams to ensure alignment on deliverables and timelines.

Prepare toxicology quotes and scopes of work for new and existing clients.
3. Training & Mentoring
Provide training and technical guidance to junior toxicologists and related staff.

Develop internal SOPs on toxicology and risk assessment best practices.



4. Regulatory Knowledge & Compliance
Stay updated on relevant regulations and scientific advances in toxicology and risk assessment.

Ensure all work complies with internal quality standards and external regulatory expectations.

Qualifications:

PhD or MSc in Toxicology, Pharmacology, or a related life sciences discipline.
Minimum 8-12 years of experience in toxicology and human health risk assessment.
Demonstrated experience preparing PDE and OEL reports.
Strong knowledge of global regulatory frameworks (e.g., EMA, FDA, REACH, ICH).
Excellent written and verbal communication skills.

Preferred Skills:

Board certification (e.g., DABT or ERT) is a strong plus.
Familiarity with toxicological modeling tools and databases.
Experience working in a CRO, pharmaceutical, or regulatory consulting environment.