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Drug Safety Assessment Job at Lupin Research Park, Pune

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Lupin Limited is hiring for its Drug Safety Assessment Team at Lupin Research Park, Pune. This opportunity is ideal for candidates with a Master’s in Pharmacology and 1–4 years of experience in preclinical safety studies, laboratory documentation, and GLP-compliant research environments.

If you are looking to advance your career in drug safety assessment, toxicology studies, and regulatory safety documentation, this role offers hands-on exposure to in-life and terminal phase safety studies within a leading pharmaceutical R&D setup.


🔬 Job Overview – Drug Safety Assessment (Preclinical Safety)

  • Company: Lupin Limited
  • Department: Drug Safety Assessment Team
  • Location: Lupin Research Park, Pune, Maharashtra
  • Experience: 1–4 years
  • Qualification: M.Pharm (Pharmacology)
  • Employment Type: Full-time

This role focuses on preclinical safety evaluation, literature review for regulatory documentation, GLP compliance, and animal study handling, making it suitable for pharmacology professionals aiming to build a long-term career in toxicology and non-clinical safety research.

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🧪 Key Responsibilities

1️⃣ Literature Search & Regulatory Support

  • Conduct structured literature searches to support regulatory write-ups and safety documentation.
  • Assist in compiling data for non-clinical safety study reports.
  • Contribute to regulatory submissions aligned with GLP and global guidelines.

2️⃣ In-Life & Terminal Phase Study Support

  • Provide operational support during in-life and terminal phases of safety studies.
  • Coordinate study-related activities in compliance with protocol requirements.
  • Ensure proper sample tracking and documentation.

3️⃣ Laboratory Documentation & Record Maintenance

  • Maintain accurate laboratory notebooks, worksheets, and raw data records.
  • Ensure documentation integrity as per Good Laboratory Practices (GLP).
  • Support audits and quality inspections when required.

4️⃣ Animal Handling & Sample Collection

  • Acquaintance with:
    • Animal handling and dosing procedures
    • Collection of biological samples (blood, urine, feces)
  • Ensure humane and ethical practices as per regulatory norms.

5️⃣ SOP & GLP Compliance

  • Adhere strictly to written Standard Operating Procedures (SOPs).
  • Maintain compliance with GLP principles and internal quality systems.

🎓 Eligibility Criteria

Educational Qualification:

  • Master’s in Pharmacology (M.Pharm – Pharmacology)

Experience:

  • 1–4 years in:
    • Drug safety assessment
    • Toxicology or preclinical research
    • GLP-compliant laboratory environment

Required Skills:

  • Knowledge of non-clinical safety studies
  • Familiarity with regulatory documentation
  • Strong laboratory record management
  • Basic understanding of toxicological endpoints
  • Attention to detail and compliance mindset

💼 Why Join Lupin Research Park?

  • Work with a reputed global pharmaceutical company
  • Exposure to regulated preclinical safety and toxicology studies
  • Career growth in drug safety and regulatory sciences
  • Structured R&D environment with GLP-compliant infrastructure
  • Opportunity to contribute to real-world drug development programs

📩 How to Apply

Interested candidates can share their updated CV to:

📧 mayurmburad@lupin.com

Subject Line Suggestion: Application – Drug Safety Assessment – Pune

Apply at the earliest, as positions in drug safety assessment and toxicology research are highly competitive.

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