Drug Safety Assessment Specialist
🏢 About Lupin Research Park
Lupin Limited is a global pharmaceutical leader known for innovation in drug development, generics, and specialty medicines.
The Lupin Research Park in Pune is a state-of-the-art R&D facility supporting preclinical research, toxicology studies, and regulatory submissions.
📌 Job Overview – Drug Safety Assessment
Department: Drug Safety Assessment Team
Location: Lupin Research Park, Pune
Experience: 1–4 Years
Qualification: M.Pharm (Pharmacology)
Employment Type: Full-Time
🔬 Role Overview
This role focuses on preclinical safety evaluation, GLP-compliant documentation, and toxicology study support.
It offers hands-on exposure to in-life and terminal phase safety studies within a regulated pharmaceutical R&D environment.
🧾 Literature Search & Regulatory Support
- Conduct structured literature searches for safety documentation
- Support regulatory write-ups & non-clinical reports
- Compile safety data for submissions
- Ensure compliance with GLP & global regulatory guidelines
🧪 In-Life & Terminal Phase Study Support
- Assist during in-life and terminal phases of safety studies
- Coordinate protocol-driven study activities
- Ensure sample tracking & study documentation accuracy
📂 Laboratory Documentation & GLP Compliance
- Maintain laboratory notebooks & raw data records
- Ensure documentation integrity under GLP principles
- Support audits & quality inspections
🐁 Animal Handling & Sample Collection
- Assist in animal handling & dosing procedures
- Collect biological samples (blood, urine, feces)
- Ensure ethical & humane practices
📋 SOP & Compliance Responsibilities
- Adhere to Standard Operating Procedures
- Maintain GLP compliance & quality systems
- Support regulatory readiness & inspections
🎓 Eligibility & Skills
- M.Pharm (Pharmacology)
- 1–4 years experience in toxicology or preclinical research
- Knowledge of non-clinical safety studies
- Understanding of regulatory documentation
- Familiarity with toxicological endpoints
- Strong attention to detail & compliance mindset
🌟 Why Join Lupin Research Park?
- Work with a reputed global pharmaceutical company
- Exposure to GLP-compliant toxicology studies
- Career growth in drug safety & regulatory sciences
- Structured R&D environment
- Contribution to real-world drug development programs
This role involves GLP-compliant toxicology studies and animal handling. Ensure your experience and comfort align with preclinical safety research requirements.
📧 Apply via Email
Send your updated CV to:
mayurmburad@lupin.com
Subject Line: Application – Drug Safety Assessment – Pune
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