Home
Jobs
Companies
Resume
NOVARTIS logo

Principal Scientist 2 - Preclinical Safety

6 - 11 years

22 - 27 Lacs

Hyderabad

Posted:3 weeks ago| Platform: Naukri logo

Apply

Skills Required

toxicology Data analysis Scientific writing Risk assessment Life sciences GLP NDA Document management Pharmacokinetics biomedical

Work Mode

Work from Office

Job Type

Full Time

Job Description

The Preclinical Safety (PCS) department within the Novartis Biomedical Research - Translational Medicine Unit provides non-clinical safety strategy of products in -discovery, -development and -market, globally, with state-of-the-art regulatory compliance. As a Principal Scientist-2, you will join our PCS team in India to discuss strategies and deliver non-clinical safety deliverables for the products you are globally responsible for. This role also involves development and review of nonclinical scientific submission components (eCTD module 2.4 and 2.6) and other lifecycle management regulatory documents for multiple projects. Key Responsibilities : 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 (SD) 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

More Jobs at NOVARTIS

Innovative Access Head

Thrissur, Trivandrum, Kozhikode, Kochi

5 - 6 yrs
|

INR 17 - 21 Lacs

Territory Business Executive

Kota, Jodhpur, Bikaner, Jaipur

5 - 10 yrs
|

INR 8 - 8 Lacs

Manager

Hyderabad

8 - 13 yrs
|

INR 20 - 25 Lacs

Associate Global Program Regulatory Manager

Hyderabad

18 - 20 yrs
|

INR 50 - 75 Lacs

Manager, Deployment Services

Hyderabad

6 - 11 yrs
|

INR 9 - 14 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Toxicology Interview Now

My Connections NOVARTIS

Download Chrome Extension (See your connection in the NOVARTIS )

chrome image
Download Now
NOVARTIS
NOVARTIS
www.novartis.com

Pharmaceutical Manufacturing

Basel Baselstadt

10001 Employees

433 Jobs

    Key People

  • Vas Narasimhan

    CEO

  • Marie-France Tschudin

    President, Innovative Medicines

RecommendedJobs for You

Novartis India logo

Principal Scientist 2 - Preclinical Safety

Novartis India

Hyderabad, Telangana, India

NOVARTIS logo

Principal Scientist 2 - Preclinical Safety

NOVARTIS

Hyderabad

Mercer logo

Senior Manager - Research

Mercer

Mumbai

Mercer logo

Lead Specialist - Research

Mercer

Mumbai

Cronus Pharma logo

immediate Need- Analytical R&D- Executive - (Injectables)

Cronus Pharma

Hyderabad

Emerson logo

India R&D Site Lead:

Emerson

Bengaluru

Olon Active Pharmaceutical Ingredients India Priva Te logo

Executive or Sr. Executive or Assistant Manager R&D

Olon Active Pharmaceutical Ingredients India Priva Te

Mahad, Raigad

Reliance Industries logo

Research Scientist

Reliance Industries

Navi Mumbai

Reliance Industries logo

Research Scientist

Reliance Industries

Jāmnagar

Research Scientist

Reliance Industries

Navi Mumbai, Maharashtra