Title:  Manager - DSE

Position: Toxicologist

Educational qualification: M. Pharm, (specialization in Toxicology), M. Sc. in Biochemistry /Microbiology/Toxicology,  B.V.Sc /M.V.Sc  or any other equivalent qualification

Experience: 6-10 years

Desirable:

• Experience of conducting animal toxicology studies (Genotoxicity studies, Repeat dose general toxicity studies etc.)
• Determination of health based exposure limit (OEL and PDE).
• Preparation of non-clinical dossier (as per CTD modules) for regulatory submission

Job Description:

1. Determination of health based exposure limit (OEL and PDE).
2. Preparation of non-clinical dossier (as per CTD modules) for regulatory submission
3. Risk assessment of process and degradation impurities, residual solvents etc. and to determine safe limit.
4. Safety evaluation for various excipients used in formulations and to determine safe limit.
5. Assessment of Extractables and Leachables.
6. Genotoxicity hazard assessment of starting materials, raw materials, intermediates, residual solvents, degradation products etc using (QSAR) softwares [according to ICH M7]
7. Toxicological evaluation of out of specification (OOS) of drug products for health hazard evaluation (HHE).
8. Environmental risk assessment (ERA) of drug products.
9. Assessment of nitrosamine impurities.
10. Active collaboration with cross-functional teams (CFTs).
11. Monitoring of out sourced non-clinical studies.
12. Other tasks, as directed by the manager(s) or determined during the annual objectives setting process.