Case Specialist

Job Description

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.