1. Study Planning and Design
- Design and develop toxicology study protocols in accordance with OECD, ICH, Schedule Y, ISO 10993, and sponsor requirements.
- Determine study objectives, dose levels, route of administration, treatment duration, and animal requirements.
- Prepare study plans, amendments, and study-related documentation.
- Conduct risk assessment and feasibility evaluation for proposed studies.
2. Animal Management and Welfare
- Ensure animal studies are conducted in compliance with CCSEA, IAEC, and institutional animal welfare requirements.
- Monitor animal health, clinical signs, morbidity, mortality, and humane endpoints.
- Review animal housing, environmental conditions, feed, and water quality.
- Ensure proper animal identification, randomization, and group allocation.
3. Conduct of Toxicology Studies
- Supervise acute, sub-acute, sub-chronic, chronic, reproductive, developmental, dermal, inhalation, and specialized toxicology studies.
- Oversee dose formulation preparation, administration, and accountability.
- Ensure accurate collection of body weight, feed consumption, clinical observations, ophthalmology, functional observations, and other study parameters.
- Coordinate biological sample collection (blood, urine, tissues, organs) and necropsy activities.
4. Data Analysis and Interpretation
- Review toxicological, clinical pathology, organ weight, and histopathology data.
- Evaluate treatment-related findings and determine No Observed Adverse Effect Level (NOAEL), Maximum Tolerated Dose (MTD), and target organs of toxicity where applicable.
- Perform scientific interpretation of study results and toxicological risk assessment.
- Collaborate with pathologists, biostatisticians, and bioanalytical scientists for integrated data evaluation.
5. Reporting and Documentation
- Prepare study reports, summary reports, and regulatory submission documents.
- Review and approve data tables, figures, and statistical analyses.
- Ensure study reports accurately reflect study conduct and findings.
- Address sponsor, QA, and regulatory authority queries.
Qualification: M-Pharm (Pharmacology) 4 to 6 years or Ph.D 1 to 2 year
Pay: From ₹25,000.00 per month
Benefits:
- Food provided
- Paid sick time
- Provident Fund
Work Location: In person
