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Principal Scientist - Preclinical Safety

Principal Scientist - Preclinical Safety

ConfidentialHyderabad / Secunderabad, Telangana
25 days ago
Job description
  • Strategy and delivery of PCS deliverables for products under development and in-market.
  • Independently provide PCS inputs in PSURs, DSURs, annual reports, registrations, renewals and label updates for the delegated products.Addresses regulatory queries on delegated products.
  • Conducts literature searches and analyzes relevant non-clinical safety data and decide benefit-risk of new nonclinical information in collaboration with patient safety experts.
  • Contribute to the objectives and deliverables of (Global Project Team) in cross-functional collaboration with other GPT representatives.
  • Evaluates the toxicological profiles of impurities, degradants and assess the specification limits based on ICH guidelines.
  • Provides to nonclinical scientific writing support fo regulatory submission documents such as, IB, IND / CTA, NDA / BLA / MAA and Health Authority briefing books.
  • Organizes nonclinical scientific activities and timelines in collaboration with authors for planned submission to meet strategic objectives of nonclinical submission deliverables.
  • Develop expertise in internal Document management system to facilitate timely completion of projects and meet compliance requirement.
  • Act as a nonclinical scientific liaison to Submissions & Documentation (S&D) vendor supporting nonclinical submission document management.
  • Ensure that all the activities and deliverables are compliant with Novartis animal welfare policies, in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines / regulations.
  • Be a team player and support local implementation of Preclinical safety strategies and independently contribute to multidisciplinary project / program goals within the Preclinical safety team. Communication skill is critical to this role in forming strong working relationships with team members and across functional disciplines.
  • Essential Requirements :

    • PhD in life sciences with 6+ years experiences in drug discovery, drug development and / or life cycle management studies with an exceptional understanding of nonclinical submission writing
    • In-depth knowledge of toxicology and preclinical safety assessment, understanding of drug metabolism and pharmacokinetics / pharmacodynamics, experience working in project teams, and knowledge of drug development and regulatory environment
    • Understanding of GLP principles in nonclinical studies and submission writing.
    • Proficient with full range of techniques used in job and core areas. Working knowledge of tools and processes used in drug design and development.
    • Extensive library research skills and knowledge of problems-solving techniques; publication and presentation experience preferred.
    • Excellent communicators, strong team players and have a high level of logistical / planning ability.Strong written and verbal capabilities in English preferred.
    • Registration and certification with one of the International Toxicology registers.
    • Desirable Requirement :

    • Animal Models ,Communication Skills, Data Analysis.
    • Ethics ,Laboratory, Problem Solving.
    • Regulatory Compliance.
    • Research.
    • Risk Assessment.
    • Toxicology.
    • Skills Required

      toxicology , Risk Assessment, Regulatory Compliance, drug development

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    Principal Scientist • Hyderabad / Secunderabad, Telangana

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