Principal Scientist – Preclinical Safety

6+ years

Not Disclosed

Hyderabad

10 July 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

Summary

The Preclinical Safety (PCS) department within Novartis Biomedical Research - Translational Medicine Unit oversees the non-clinical safety strategy for products throughout their lifecycle, from discovery through development to market. As a Principal Scientist-2, you will be an integral part of our PCS team in India, responsible for discussing strategies and delivering non-clinical safety outcomes for global projects. This role involves developing and reviewing nonclinical scientific submission components (eCTD modules 2.4 and 2.6) and other lifecycle management regulatory documents for multiple projects.

About the Role

Key Responsibilities:

Strategic Oversight: Develop and deliver PCS strategies for products under development and in-market.
Regulatory Submissions: Independently provide PCS inputs for PSURs, DSURs, annual reports, registrations, renewals, and label updates. Address regulatory queries related to delegated products.
Data Analysis: Conduct literature searches, analyze non-clinical safety data, and assess the benefit-risk of new information in collaboration with patient safety experts.
Cross-Functional Collaboration: Contribute to the Global Project Team (GPT) objectives and deliverables by collaborating with other GPT representatives.
Toxicology Evaluation: Assess the toxicological profiles of impurities and degradants, setting specification limits based on ICH guidelines.
Scientific Writing: Support the preparation of regulatory submission documents including IB, IND/CTA, NDA/BLA/MAA, and Health Authority briefing books.
Project Management: Organize nonclinical scientific activities and timelines to meet strategic objectives, leveraging internal document management systems to ensure compliance and timely project completion.
Vendor Liaison: Act as a scientific liaison to Submissions & Documentation (S&D) vendors, managing nonclinical submission document activities.
Compliance: Ensure all activities adhere to Novartis animal welfare policies, standard operating procedures, and international regulatory guidelines.
Team Collaboration: Support local implementation of PCS strategies and contribute to multidisciplinary project/program goals within the Preclinical Safety team. Strong communication skills are essential for building effective working relationships across disciplines.

Essential Requirements

Education: PhD in life sciences.
Experience: Minimum of 6 years in drug discovery, development, or lifecycle management studies, with a strong background in nonclinical submission writing.
Knowledge: In-depth understanding of toxicology, preclinical safety assessment, drug metabolism, pharmacokinetics, and pharmacodynamics. Familiarity with GLP principles and regulatory environments.
Skills: Proficiency in various techniques and tools used in drug design and development. Extensive library research skills and problem-solving techniques. Experience in publication and presentation preferred.
Communication: Excellent verbal and written communication skills in English. Ability to work effectively within a high-performing, global organization.
Certification: Registration and certification with one of the International Toxicology registers.

Desirable Requirements

Specialized Skills: Experience with animal models, data analysis, regulatory compliance, risk assessment, and toxicology.
Ethics & Problem Solving: Strong understanding of ethical considerations, problem-solving skills, and laboratory research.

Commitment to Diversity & Inclusion

Novartis is dedicated to creating an inclusive work environment and diverse teams that reflect the patients and communities we serve.

Why Novartis: Our mission is to reimagine medicine to enhance and extend lives. Join us and be a part of a team that drives innovation and achieves breakthroughs in patient care. Learn more about our vision and people at Novartis Strategy.

Benefits: Discover our benefits and rewards at the Novartis Life Handbook.

Join the Novartis Network: If this role isn’t a perfect fit but you're interested in staying connected, join our talent community for future opportunities at Novartis Talent Network.

Location

Division: Biomedical Research
Business Unit: Pharma Research
Location: Hyderabad, India
Company/Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area: Research & Development
Job Type: Full-time
Employment Type: Regular
Shift Work: No

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Principal Scientist – Preclinical Safety

Job Description

Summary

About the Role

Essential Requirements

Desirable Requirements

Commitment to Diversity & Inclusion

Location

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