Role & responsibilities

Preclinical Pharmacology & Toxicology

Experience: 06 to 11 years

Department: Preclinical Pharmacology & Toxicology

Reporting to: Lead, Preclinical Research / Department Head

Qualification: M.Pharm or Ph.D. in Pharmacology, Toxicology, Life Sciences, or a related discipline.

Job Purpose

Lead the scientific planning, execution, interpretation, documentation, and regulatory delivery of preclinical pharmacology, safety pharmacology, and toxicology studies while ensuring animal welfare, data integrity, and compliance with applicable ethical and regulatory requirements.

Key Responsibilities

- Design and lead efficacy, pharmacology, safety pharmacology, dose-range-finding, acute and repeated-dose toxicity, local tolerance, and other preclinical studies.
- Develop scientifically justified study strategies, animal models, dose selection, endpoints, sampling schedules, and statistical analysis plans.
- Act as Study Director or Principal Investigator, where applicable, and ensure studies are conducted according to approved protocols, SOPs, and timelines.
- Review animal handling, dosing, clinical observations, sample collection, necropsy, organ weighing, and specimen-processing procedures.
- Interpret pharmacological, toxicological, clinical pathology, bioanalytical, and histopathological findings.
- Evaluate exposure-response relationships, target-organ toxicity, reversibility, safety margins, NOAEL, MTD, and translational relevance.
- Identify study risks, deviations, unexpected findings, and animal-welfare concerns, and implement scientifically appropriate corrective actions.
- Coordinate with pathology, bioanalysis, formulation, quality assurance, regulatory affairs, project management, and external research organizations.
- Mentor junior scientists and research associates, assign responsibilities, and assess technical competency.
- Support laboratory capability development, method qualification,



equipment selection, SOP development, and process improvement.

Documentation and Reporting

- Support regulatory and quality audits, facility inspections, study reconstruction, and responses to audit observations.
- Promote scientific integrity, biosafety, confidentiality, controlled-document practices, and ethical research conduct.
- Author and review study protocols, amendments, study plans, raw-data formats, SOPs, technical procedures, and statistical analysis plans.
- Prepare and review IAEC submissions, animal-use justifications, humane-endpoint criteria, and ethical approval documentation.
- Review raw data, worksheets, logbooks, formulation records, sample-accountability records, deviations, and investigation reports.
- Prepare scientifically sound study reports, integrated summaries, literature reviews, risk assessments, and regulatory responses.
- Ensure documentation follows ALCOA+ principles and is complete, accurate, contemporaneous, attributable, legible, and traceable.
- Ensure proper document control, version management, data reconciliation, quality review, archival, and retrieval.
- Review vendor and CRO protocols, reports, data packages, certificates, and study deliverables.
- Contribute to investigator brochures, nonclinical summaries, regulatory dossiers, and responses to agency queries.

Preferred Experience Experience as a Study Director or Principal Investigator, preparation of regulatory submissions, handling regulatory queries, managing CRO studies, participating in audits or inspections, and working with rodent and non-rodent preclinical models will be preferred.

Key Performance Expectations

Deliver scientifically robust and regulator-ready studies within agreed timelines, maintain high standards of animal welfare and data integrity, ensure inspection-ready documentation, resolve study risks proactively, and develop the technical capabilities of junior team members.

Preferred candidate profile

📌 Senior Research Scientist-Preclinical Pharmacology & Toxicology (Baddi)
🏢 Venus Remedies (VRL)
📍 Baddi