Key Responsibilities
- Nonclinical safety and toxicology study design & execution -
1. Design, plan, and conduct in vivo and/or in vitro safety pharmacology and toxicology
studies in alignment with GLP principles.
2. Select appropriate species, study duration, and endpoints based on pharmacology,
pharmacokinetics and regulatory requirements.
3. Review study raw data, protocols, results and reports.
4. Oversee study execution, ensure data accuracy, and coordinate with CROs or internal cross
functional teams.
• Risk Assessment & Safety Evaluation -
1. Analyse and interpret the safety and toxicology data and integrate findings with pharmacokinetics and pharmacodynamics to assess potential safety risks.
2. Perform toxicological risk assessments including PDE/OEL/ADI derivations, impurity/excipient qualification assessments, extractables & leachables evaluations, and safety margin calculations.
3. Conduct exposure assessments for process materials, impurities, metabolites, degradation products and excipients.
• Regulatory & Documentation -
1. Prepare and review high-quality safety and toxicology study reports, technical summaries, and nonclinical sections of regulatory submission documents (IND, NDA/MAA, ANDA, eCTD Modules 2.4/2.6 & 4, briefing books and IB, etc.).
2. Support regulatory filings to USFDA, EMA, DCGI, and other global agencies.
3. Draft and review regulatory query responses, briefing documents, and expert justifications.
• Toxicology Informatics & Literature Research -
1. Perform comprehensive literature searches using toxicity databases (e.g., PubMed, TOXNET, ECHA, HSDB, etc.,).
2. Utilize modern toxicity prediction & risk assessment software/tools (e.g., DEREK Nexus, CASE Ultra, OECD QSAR Toolbox, etc.).
3. Interpret computational toxicology outputs and integrate them into safety evaluations.
• Compliance & Quality -
1. Ensure full adherence to global regulatory guidelines (ICH, OECD, EMA, and USFDA).
2. Support internal audits, regulatory inspections, and quality compliance activities related to toxicology studies.
• Cross-Functional Collaboration
1. Work closely with Pharmacology, ADME, DMPK, CMC, Clinical and Regulatory Affairs teams.
2. Represent toxicology in project meetings and contribute to risk/benefit evaluations.
