Urgent Requirement For Toxicology Expert Pharmacovigilance Department

MSN Group

5 - 10 years

4 - 7 Lacs

hyderabad

Posted:3 days ago| Platform:

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Skills Required

pde/oel report generation european registered toxicologist dabt toxicological eu regulatory guidelines pharmacovigilance risk assessment continuous development cross-functional collaboration

Work Mode

Work from Office

Job Type

Full Time

Job Description

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).

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