Biocompatibility Engineer Larsen & Toubro (L&T)

4.0 - 8.0 years

6 - 16 Lacs

mysuru

Work from Office

Job Description of Biocompatibility/Toxicological Risk Assessment/Chemical Analyst- Senior Engineer or Tech lead 1. Develop and prepare a biological evaluation plan and report. 2. Perform gap assessments of products by reviewing legacy documentation and evaluating device BOMs to determine the applicability of test data to ISO 10993 standard. 3. Write biological risk assessments to ensure all the relevant end points mentioned in ISO 10993 are met. 4. Participate in the analysis of technical issues and in the development of recommendations for project decisions and actions. 5. Good Knowledge in of EU MDR 2017/745, ISO 13485, and ISO 14971. 6. Well Exposure in Chemical and material characteriza...

Posted 5 days ago

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Urgent Requirement For Toxicology Expert Pharmacovigilance Department MSN Group

5.0 - 10.0 years

4 - 7 Lacs

hyderabad

Work from Office

JD for toxicology expert. Key Responsibilities: Toxicological Assessment: Evaluating toxicological data to identify hazards, perform dose-response analysis, and integrate safety factors to calculate PDE values. PDE/OEL Report Generation: Preparing detailed, regulatory-ready PDE and OEL reports in accordance with EMA, ICH, FDA, and OSHA guidelines. Risk Assessment: Performing comprehensive risk assessments to evaluate cross-contamination risks in multi-product facilities and industrial hygiene risks. Regulatory Compliance: Ensuring compliance with global regulatory standards for exposure limits and worker safety. Cross-Functional Collaboration: Working with manufacturing, validation, and othe...

Posted 1 month ago

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Senior Specialist, Thepharmadaily

4.0 - 6.0 years

3 - 7 Lacs

Hyderabad, Telangana, India

On-site

Key Responsibilities Toxicological Risk Assessment: Evaluate impurities and excipients in pharmaceutical products to assess potential health risks. Structure-Activity Relationship (SAR) Evaluation: Analyze chemical structures using Structure-Activity Relationship methods, including Quantitative Structure-Activity Relationship (QSAR) models, to identify health hazards in unstudied compounds. Read-Across Evaluation: Identify structural analogues and develop scientific rationales to support read-across assessments for untested chemicals. Impurity Specification Development: Develop safety justifications for setting impurity specifications in pharmaceutical products. Literature Exploration: Condu...

Posted 2 months ago

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Research Associate - Pre-Clinical Cadila Pharmaceuticals

2.0 - 5.0 years

3 - 5 Lacs

Dholka

Work from Office

Role & responsibilities 1. Act as Study Director for various Pre-Clinical studies as per guidelines 2. Conduct, schedule & report toxicological studies for various products in pre-clinical studies 3. Conduct a Pharmacological evaluation of various pharmaceutical products 4. Preparation of SOP & documentation as per guidelines 5. Ensuring facility readiness as per regulatory guidelines & audits

Posted 3 months ago

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Preclinical scientist Shilpa Medicare

6.0 - 10.0 years

6 - 13 Lacs

Hyderabad

Work from Office

Role & responsibilities Support Preclinical Development Strategy Assist in devising and implementing preclinical development strategies for new drugs or generics, including literature review and assimilation of relevant scientific data. Contribute to the design and planning of in vivo and in vitro studies, ensuring alignment with regulatory and therapeutic goals. Study Management and Oversight: Coordinate and support the execution of pharmacodynamics, pharmacokinetics, and toxicological studies, often at contract research organizations (CROs). Verify test article characterization data and review preclinical study protocols, data, and reports for accuracy and compliance. Ensure timely executi...

Posted 4 months ago

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