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Research Associate Ii - Preclinical

4-6 years
₹10 – ₹18 LPA
10 July 29, 2025
Job Description
Job Type: Full Time Education: M.Sc./M.Pharm/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Research Associate II – Preclinical (Toxicology & Biocompatibility)
Location: Bengaluru, India
Job ID: JR - 178340
Job Type: Full-time
Department: Research and Development
Date Posted: July 10, 2025
Estimated Salary: ₹10 – ₹18 LPA (based on qualifications and experience)


About Vantive:
Vantive is a global innovator in vital organ therapy, with a 70-year legacy in delivering advanced care across dialysis and organ support. We’re expanding our impact by investing in digital solutions and smarter drug-device combinations. At Vantive, your expertise contributes directly to improving patients' lives.


Role Overview:
As a Research Associate II – Preclinical, you will apply your expertise in toxicology and biocompatibility to design and execute safety evaluations of drugs, drug-device combinations, and medical devices. You'll support preclinical development through risk assessments, regulatory documentation, and technical leadership in compliance with ISO 10993 and ICH guidelines.


Key Responsibilities:

  • Study Design & Monitoring:

    • Independently or collaboratively plan, monitor, and document GLP-compliant toxicity and biocompatibility studies.

    • Contribute to qualification of extractables, leachables, residual solvents, and excipients.

    • Author toxicological risk assessments and regulatory documentation (e.g., PBRER, eCTD).

  • Toxicological Assessment:

    • Conduct hazard evaluations of chemicals and author Safety Data Sheets (SDS).

    • Utilize in silico tools to predict toxicological endpoints.

    • Interpret toxicology results, draw conclusions, and prepare reports for regulatory submissions.

  • Regulatory & Technical Collaboration:

    • Act as SME for preclinical/toxicology functions in technical team meetings.

    • Participate in impact assessments and change control processes.

    • Ensure adherence to OECD, GLP, ICH Q3, ISO 10993-17, and FDA toxicology standards.


Required Qualifications:

  • Education:

    • Master’s degree in Life Sciences, Pharmacy, Biotechnology, or Veterinary Sciences with 4–6 years of experience

    • OR Ph.D. with relevant thesis/Post-doc in in vitro/in vivo toxicology, sterile injectable R&D, or medical device testing

  • Technical Skills:

    • Proficiency in toxicological study design, GLP compliance, ISO 10993-17, ICH Q3

    • Familiarity with in silico tools and risk assessment methods

    • Strong documentation and data interpretation abilities

  • Soft Skills:

    • Clear, concise communication in English (written & verbal)

    • Ability to independently manage multiple priorities

    • Proven stakeholder collaboration in a matrixed global environment


Why Vantive?

  • Engage in meaningful work that supports global regulatory submissions and patient safety

  • Be part of a forward-thinking team that drives preclinical excellence in drug-device R&D

  • Thrive in a culture that values courage, focus, and never settling for mediocrity