REGULATORY TOXICOLOGIST FOR SAFETY ASSESSMENT

Roles and Responsibilities Conducting literature search and preparation of Toxicological assessment for Chemicals/ Pharmaceuticals / Medical devices E&L. Preparation and review of Nonclinical overview (NCO) for CTD submission of dossier filing. Preparation and review of Health Based Exposure Limits (PDE/ OEL/ ADI) reports for Pharmaceuticals/ Chemicals. Preparation and review of in silico toxicity prediction reports and ICH M7 genotoxicity reports Scientific literature search to extract, analyze and collate toxicology data from various clinical/toxicology/efficacy related databases like PubMed, ScienceDirect etc. Evaluation of quality of different toxicity studies (such as systemic toxicity, genotoxicity, irritation, sensitization, carcinogenicity, reproductive and developmental toxicity, toxicokinetic studies) as per OECD/ ICH /FDA/ ISO/ EPA guidelines. Preparation of Risk Assessment reports for Extractables and Leachables including calculation of Tolerable Intake in line with ISO standards. Preparation of Safety Data sheet in compliance with GHS. Preparation of research reports/ dossiers according to international regulatory guidelines. Preparation and review of reports for non-clinical studies conducted as per ICH/ OECD/ ISO guidelines