Location
Chennai | India
Job description
Job Description (Posting).
1. Master's degree/ Ph.D. in pharmacology, Biotechnology, veterinary science, life sciences, or relevant science discipline.
2. Minimum 5 to 8 years of experience in preclinical toxicology and biocompatibility testing.
3. Experimental data analysis, interpretation, and report preparation.
4. In-depth understanding of ISO 10993 Parts, OECD, ICH, and EU-MDR standards/ guidelines.
5. Evaluate, interpret, and summarize biocompatibility/toxicological testing data.
6. Knowledge of the field of product safety assessment as per EU-MDR and FDA regulations.
7. Experience in technical writing, as well as test protocol/report preparation.
8. Experience in toxicological risk assessment per ISO 10993-17 and raw materials safety assessment.
9. Familiar with the calculation of Permitted Daily Exposure/Acceptable Daily Intake/Reference Dose/Margin of Safety (MoS)/ Tolerable Intake (TI)
10. Hands-on experience with in-silico prediction tools
11. Literature search and safety data (preclinical and clinical) collection for identified issues seeking toxicology and clinical safety support.
(1.) To develop and guide the team members in enhancing their technical capabilities and increasing productivity (2.) TO ensure process compliance in the assigned module, and participate in technical discussionsorreview. (3.) To prepare and submit status reports for minimizing exposure and risks on the project or closure of escalations. (4.) To be responsible for providing technical guidance or solutions, recommend value creation initiatives to clients and implement industry best practices.
Qualification
B-Tech
Skill (Primary)
Domain Competencies (ERS)-Materials-Toxicology
Job tags
Salary
