Job for Scientist Toxicology and Clinical Safety at Johnson and Johnson

Janssen India, the pharmaceutical division of Johnson & Johnson India, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neuroscience and analgesia, dermatology, infectious diseases and metabolic diseases. Driven by a strong dedication to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world.

Post : Scientist - Toxicology/Clinical Safety

Job Description
• Literature search & safety data (preclinical and clinical) collection for identified issues seeking toxicology and/or clinical safety (skin tolerance) support.
• Literature review for hazard assessment of ingredients intended to be used in consumer and preparation of their toxicology profiles.
• Assessment and approval of fragrances and flavors used in consumer products.
• Toxicology Risk assessment for raw materials and formulations for cosmetic applications including Margin of Safety calculations and approval of products.
• Assessment of skin tolerance of cosmetic ingredients and products from preclinical and clinical perspectives.
• Review and Interpretation of clinical skin safety studies (patch test, phototoxicity, irritation and sensitization studies)
• Safety assessments for impurities, degradants and products as per regulatory requirements.
• Review of products at different stages of development cycle
• Preparation of technical justification reports for regulatory submission.
• Addressing and evaluating the risk of compliance issues raised by regulatory authorities & QA, and impurity qualification
• Toxicology/clinical Study monitoring, interpretation and managing third party
• Communication with business partners on requirements, prioritization and deliverables on safety assessment reports
• Review of activities conducted by third party associates
• Maintain documents via the product safety & compliance SharePoint site.

Candidate Profile
• Master’s degree/ Ph.D. in toxicology, pharmacology or relevant science discipline.
• 3-5 years of experience in the field of consumer product risk assessment or other relevant Toxicology and/or Clinical safety (skin tolerance) experience.
• Diplomate of the American Board of Toxicology (DABT) certification, Diploma in clinical sciences preferred.
• Knowledge of In silico toxicity prediction tools
• Good verbal and written communication skill in English is a must.
• Individual with strong interpersonal skills and able to work independently
• Desirable: Knowledge of regulatory requirements for product safety submissions and experience in medical writing.

Additional Information
Experience : 3-5 years
Qualification : Master’s degree/ Ph.D. in toxicology, pharmacology
Location : Maharashtra - Greater Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 30th May, 2021