Vaf

**Responsibilities : -**:

- Conduct comprehensive toxicology risk assessments across diverse scenarios, ensuring robust safety evaluations.
- Conduct & review of toxicology risk assessments for excipients, impurities, solvents, extractables and leachables, ensuring adherence to regulatory standards.
- Execute Environmental Risk Assessments (ERA) in compliance with the latest EMA guidelines.
- Prepare, maintain, and update toxicology summaries for globally marketed products in alignment with company policies.
- Develop and compile PDE and OEL monographs to support safety evaluations.
- Prepare clinical and non-clinical dossier modules (Modules 2.4, 2.5, 2.6, 2.7, 4, and 5) for regulatory submissions.
- Manage preclinical studies and associated documentation to ensure compliance and accuracy.
- Perform QSAR genotoxicity assessments in accordance with ICH M7 guidelines.
- Utilize advanced in-silico predictions (DEREK, SARAH, NEXUS, TOXTREE, OECD Toolbox) for data analysis and risk assessment.
- Provide expert guidance in addressing client and regulatory inquiries effectively.

**Background Required -**:

- Qualified Toxicologist
- Signing non-clinical/ toxicological reports/ modules/ expert reports
- Drafting of Environmental risk assessment reports
- Due diligence of pre-clinical data and drafting strategy for non-clinical studies for complex generics, NCEs, Biologics etc
- Drafting and review of non-clinical CTD modules
- Drafting of PDE reports
- Toxicological risk assessment of impurities/ leachables/ extractables

**Required education**:

- Qualified and experienced Toxicologist

**Required experience**:

- At least 2 years of experience in above mentioned activities.