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Urgent Requirement For Toxicology Expert Pharmacovigilance Department

4 weeks ago

Hyderabad, India MSN Group Full time

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 other teams to integrate PDE/OEL data into cleaning validation, risk management files, and facility design.
  • Data Analysis:Analyzing and interpreting toxicology and exposure data to derive safe exposure levels.
  • Continuous Learning:Staying updated on the latest industry best practices, regulatory guidelines, and advancements in toxicological risk assessment.

Typical Qualifications:

  • Education: MSc or PhD in Pharmacology or Toxicology.
  • Experience: 2-5 years of relevant experience in PDE/OEL and QSAR (Quantitative Structure-Activity Relationship) assessments.
  • Knowledge: Strong understanding of toxicological risk assessment methodologies, regulatory requirements for exposure limits, and compliance standards.
  • Skills: Excellent analytical, problem-solving, and communication skills.
  • Certifications (Preferred): European Registered Toxicologist (ERT) or Diplomate of the American Board of Toxicology (DABT).