Urgent Requirement For Toxicology Expert Pharmacovigilance Department MSN Group

5.0 - 10.0 years

4 - 7 Lacs

hyderabad

Work from Office

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).

Posted 3 days ago

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Senior Specialist, Thepharmadaily

4.0 - 6.0 years

3 - 7 Lacs

Hyderabad, Telangana, India

On-site

Key Responsibilities Toxicological Risk Assessment: Evaluate impurities and excipients in pharmaceutical products to assess potential health risks. Structure-Activity Relationship (SAR) Evaluation: Analyze chemical structures using Structure-Activity Relationship methods, including Quantitative Structure-Activity Relationship (QSAR) models, to identify health hazards in unstudied compounds. Read-Across Evaluation: Identify structural analogues and develop scientific rationales to support read-across assessments for untested chemicals. Impurity Specification Development: Develop safety justifications for setting impurity specifications in pharmaceutical products. Literature Exploration: Conduct thorough reviews of publicly available scientific literature to support safety assessments for unstudied chemicals. Environmental Risk Assessment: Perform environmental risk assessments for pharmaceutical compounds in accordance with regulatory standards. Health Hazard Assessment: Conduct health hazard and risk assessments to address product quality issues and support decision-making for product recalls , when necessary. Your Profile Education Master's degree in Pharmacology or Pharmacy , or PhD in Pharmacology / Toxicology Expertise Strong understanding of toxicological and pharmacological principles Experience with QSAR , read-across techniques , and scientific literature evaluation

Posted 2 weeks ago

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Research Associate - Pre-Clinical Cadila Pharmaceuticals

2.0 - 5.0 years

3 - 5 Lacs

Dholka

Work from Office

Role & responsibilities 1. Act as Study Director for various Pre-Clinical studies as per guidelines 2. Conduct, schedule & report toxicological studies for various products in pre-clinical studies 3. Conduct a Pharmacological evaluation of various pharmaceutical products 4. Preparation of SOP & documentation as per guidelines 5. Ensuring facility readiness as per regulatory guidelines & audits

Posted 1 month ago

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Preclinical scientist Shilpa Medicare

6.0 - 10.0 years

6 - 13 Lacs

Hyderabad

Work from Office

Role & responsibilities Support Preclinical Development Strategy Assist in devising and implementing preclinical development strategies for new drugs or generics, including literature review and assimilation of relevant scientific data. Contribute to the design and planning of in vivo and in vitro studies, ensuring alignment with regulatory and therapeutic goals. Study Management and Oversight: Coordinate and support the execution of pharmacodynamics, pharmacokinetics, and toxicological studies, often at contract research organizations (CROs). Verify test article characterization data and review preclinical study protocols, data, and reports for accuracy and compliance. Ensure timely execution of studies in collaboration with CROs and internal teams, maintaining data integrity and regulatory compliance. Data Analysis and Interpretation Compile, analyze, and interpret preclinical data, including statistical analysis of biological results. Prepare study findings for internal discussions, decision-making, and regulatory submissions. Present results in team meetings and contribute to technical reports, study summaries, and presentations. Regulatory Support Review and prepare documentation for regulatory submissions (e.g., IND, NDA, BLA), ensuring all preclinical data meet regulatory requirements. Address and resolve regulatory queries related to pharmacokinetics, efficacy, or toxicity by providing scientific justifications and literature support. CRO and Vendor Management Participate in the identification, selection, and management of CROs for preclinical studies. Set up contracts, handle shipments, and oversee administrative tasks related to external service providers. Cross-functional Collaboration Collaborate with internal and external stakeholders, including discovery research, clinical pharmacology, and regulatory affairs, to ensure seamless project progression. Contribute to the overall translational research strategy and integrate preclinical insights into broader project decisions. Documentation and Compliance Ensure that all work is conducted in a safe, ethical, and compliant manner, adhering to Good Laboratory Practice (GLP) and other relevant standards Preferred candidate profile Perks and benefits

Posted 2 months ago

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