12 Pharmacodynamics Jobs

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait . We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets). ‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization. Job Description Job summary We are looking for a professional who is well versed in ELISA, ligand binding assays to support method development, validation and sample analysis of Pharmacokinetics, Immunogenicity, and Pharmacodynamics assays for pipeline assets Should be well versed in Enzyme linked Immuno Sorbent Assay (ELISA), Meso Scale Discovery (MSD), cell based immunoassays, FACS, LIMS, ELN and other relevant platforms. Should ensure contemporaneous data recording, documentation and reporting of results as per internal Standard Operating Procedure (SOP) and comply with quality requirements. Should have excellent written and oral skills and be able to present and share the experimental data in intra/inter departmental meetings. Should ensure calibration and preventive maintenance of critical equipment in the laboratory. Qualifications Educational qualification: Masters in Lifesciences or related Minimum work experience : 2 years of experience

Job Title: Associate Professor / Professor - Pharmacology / Pharmaceutics Location: K.R. Mangalam University, Haryana Department : School of Medical and Allied Sciences (Pharmacy) Employment Type: Full-time Job Summary: K.R. Mangalam University is looking for a highly qualified Professor in Pharmacology /Pharmaceutics to lead academic and research activities in the School of Medical and Allied Sciences. The candidate will be responsible for teaching, research, curriculum development, and industry collaboration while mentoring students and faculty members. Key Responsibilities: Teaching & Academics: Deliver lectures, tutorials, and practical sessions in Pharmacology /Pharmaceutics and related subjects at undergraduate and postgraduate levels. Develop and update course curricula in line with PCI, UGC, and NEP 2020 guidelines. Guide students in research projects, dissertations, and internships. Evaluate students through exams, assignments, and practical assessments. Research & Publications: Conduct advanced research in pharmacokinetics, pharmacodynamics, drug interactions, and clinical pharmacology / Pharmaceutics. Publish high-quality research papers in indexed journals (SCI, Scopus, PubMed, etc.). Secure research grants from national and international funding agencies. Mentor Ph.D. scholars and postgraduate students in research. Industry Collaboration & Innovation: Establish collaborations with pharmaceutical companies, clinical research organizations, and hospitals. Encourage patent filings, consultancy projects, and technology transfer. Organize seminars, workshops, and guest lectures on emerging trends in pharmacology /Pharmaceutics. Academic Leadership & Mentorship: Lead curriculum development and accreditation processes such as NAAC, NBA, and NIRF. Supervise faculty development programs and promote innovative teaching methodologies. Mentor students in career development, industry placements, and higher education opportunities. Participate in departmental and university-level academic committees. Eligibility Criteria: Educational Qualification: Ph.D. in Pharmacology / Pharmaceutics (Mandatory). Bachelor’s and Master’s degrees in Pharmacy (B.Pharm & M.Pharm) from PCI-approved institutions. Experience: 8+ years of teaching and research experience in Pharmacology / Pharmaceutics. Significant contributions to research, publications, and industry collaborations. Skills & Competencies: Expertise in pharmacological research, clinical trials, and drug development. Strong publication record in indexed journals and active participation in conferences. Leadership skills in academic administration, faculty mentoring, and curriculum development. Familiarity with modern teaching methods, e-learning platforms, and laboratory technologies. Interested Candidates can visit our website and they can send the resume on this mail id: K. R. Mangalam University Website - https://www.krmangalam.edu.in/careers/ Email ID - krmujobs@krmangalam.edu.in

Job Description: Toxicologist / Preclinical Scientist We are seeking a skilled Toxicologist / Preclinical Scientist to join our team. The ideal candidate will be accountable for conducting toxicological risk assessments and overseeing preclinical experimental research. 1. Key Responsibilities: Toxicological Risk Assessments • Derive Health-based Exposure Limits & support occupational hazard assessment (PDE/OEL) for pharmaceutical molecules in adherence to regulatory standards. • Conduct Toxicological Risk Assessments (TRA) for pharmaceuticals, excipients, intermediates, chemicals, cleaning agents, residual solvents, elemental impurities, and degradation products. • Perform Genotoxicity Hazard Assessments for impurities using published or experimental in-vitro/in-vivo data and in-silico (Q)SAR tools according to ICH M7 guidelines. • Evaluate extractable and leachable impurities using literature review and in-silico tools. • Determine Harmful Doses for children to guide selection of blister packaging. 2. Key Responsibilities: Experimental Toxicology & Preclinical Research • Develop preclinical strategies supporting differentiated product development. • Plan, outsource, oversee, and interpret in vitro and in vivo preclinical toxicology and pharmacokinetics/pharmacodynamics (PK/PD) studies for complex/differentiated products and impurity qualifications. • Plan, outsource, oversee, and interpret in vivo/ in vitro biocompatibility studies for medical devices. • Plan, outsource, oversee, and interpret in vitro immunogenicity studies for peptides and biosimilar products. • Summarize toxicological data and prepare Investigational Brochures (IBs), Investigational New Drug (IND) applications, and electronic Common Technical Document (e-CTD) for regulatory authority submissions. Qualifications and Skills • Advanced degree in Toxicology, Pharmacology, Zoology, Veterinary Medicine or related field. • Minimum 3-5 years of experience in toxicological risk assessment & experimental toxicology within the pharmaceutical, CRO or biotechnology industry. • Strong understanding of regulatory guidelines (e.g., ICH, USFDA, EMA, CFDA, DCGI) and experience with regulatory submissions. • Proven ability to manage multiple projects simultaneously and work effectively in a dynamic team environment. • Excellent communication skills with the ability to collaborate cross-functionally and interact with external partners such as CROs. • Detail-oriented with proactive planning abilities, coupled with strong analytical skills, effective timeline management, adept problem-solving capabilities, and excellent collaboration and teamwork skills. • Skilled in using computer software including Microsoft Office suite (Word, Excel, PowerPoint), SharePoint, QSAR tools, data mining software, citation tools, and other relevant applications. Operational details: • Location: Vikhroli, Mumbai. • Mode: Full time, work from office • Shifts: General shift (8 hours) • Travelling: Rare/Occasional for outdoor duties/ monitoring

As an ideal candidate for this position, you should hold a Master's degree in Pharmacy with a specialization in Pharmacology or Pharmaceutical Analysis coupled with 5-8 years of experience. Alternatively, a Ph.D. with 2-5 years of relevant experience in PK/PD Modelling and PBPK models would also be considered. Your responsibilities in this role would include developing and applying pharmacometric models to aid in drug development and regulatory submissions. You must possess a deep understanding of non-linear mixed effects modelling and be proficient in using software tools such as PBPK models, Phoenix, R, PoPK, QSP modelling, or similar platforms. Your expertise in pharmacokinetics/pharmacodynamics (PK/PD) modelling and First-in-human dose predictions will be crucial for the success of this role. Collaboration is key in this position, as you will work closely with clinical pharmacology, biostatistics, and other interdisciplinary teams to shape clinical trial designs and analyze data. Your tasks will also involve creating and executing model-based strategies to enhance dosing regimens and achieve optimal therapeutic outcomes. Ensuring the accuracy and quality of pharmacometric analyses and reports will be a significant part of your role. You will be expected to engage with regulatory agencies, preparing submission documents related to pharmacometric analyses. Staying updated on the latest advancements in pharmacometrics and integrating new methodologies and technologies as needed will be essential. Additionally, presenting your findings and strategies to project team meetings and cross-functional teams is crucial, highlighting your ability to collaborate effectively in a team environment.,

Summary Join our dynamic and innovative global Computer-Aided Drug Discovery (CADD) group, now expanding to India! Be a part of our Hyderabad team, where we unite diverse talents to revolutionize the validation and development of new targets in Biomedical Research. As a driving force behind drug discovery, we are excited to find an exceptional computational scientist like you to join our global ranks. Imagine the opportunity to unlock hidden knowledge and disruptive insights from the vast and invaluable data collected by one of the world's most renowned pharmaceutical companies. We need your expertise, experience, and unwavering passion to help us extract this wealth of information. Collaborating with a multidisciplinary group of scientists, you will be at the forefront of crafting inventive solutions to the most pressing drug discovery challenges, forging new paths toward groundbreaking medicines. Are you ready to seize this extraordinary chance to make a significant impact in the field of drug discovery? We invite you to embark on this thrilling journey with us, as we push the boundaries of what's possible in scientific exploration. Join our team and be part of a revolution that will shape the future of medicine. Together, we will transform the landscape of drug discovery, accelerate breakthroughs, and change lives. Apply now and let your expertise shine in our dynamic and forward-thinking environment. About The Role Your Responsibilities Include : Drive the design of medicinal chemistry efforts by applying in-depth knowledge of structure-activity relationships (SAR), a profound understanding of target biology, and predictive methods for assessing on- and off-target activity, physical properties, pharmacokinetics/pharmacodynamics (PK/PD), and synthetic feasibility. Thrive at the intersection of experimental and groundbreaking digital technologies, with a particular emphasis on expertise in machine learning and artificial intelligence (AI) as applied to small molecule drug discovery. Stay abreast of scientific literature and engage with internal and external scientists to incorporate biological insights into lead characterization and screening initiatives. Collaborate with interdisciplinary project teams to facilitate effective decision-making throughout the target identification to candidate nomination process. This involves applying and developing predictive models based on high-content and time-resolved screening data, including imaging techniques. Drive hypothesis generation to enhance clinical success rates for programs involving small molecules, peptides, RNAs, protein degradation, molecular glues, transient covalent inhibitors, and kinetic stabilization of drug-target complexes. Take a leading role in cross-disciplinary mechanistic studies using physics-based modeling and simulation, biophysical characterization, and cellular validation. These studies will inform the strategic targeting strategies of discovery projects, aiming for optimal mechanisms of action (MoAs). Minimum Requirements Advanced degree in medicinal chemistry, computational chemistry, computational biology, computational chemical biology, or a related field. Candidates with a laboratory-based background in chemistry and biology, supplemented with strong computational experience, are also encouraged to apply. 5+ years of experience working with project teams in a drug discovery environment. Proven track record of innovation through analogue design, leading to significant impact on discovery projects. Familiarity with drug design tools and high-performance computing environments and strong publication history in peer-reviewed journals. Skills And Abilities Proactively anticipates project needs with a clinical focus. Demonstrates rigor and diligence in idea substantiation, analogue design, and experimentation. Strong team orientation with multitasking and adaptability in support and leadership roles. Effective listener with excellent written and oral communication skills. Proficient in data visualization to effectively communicate insights. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

We are seeking a dedicated and knowledgeable Senior Resident in Pharmacology to join our healthcare team. The ideal candidate will play a crucial role in advancing pharmacological research and improving patient care through effective drug management and clinical trials. This position is suitable for candidates with 0-1 years of experience in the field. Responsibilities Assist in the development and implementation of pharmacological research protocols. Conduct clinical trials and monitor patient responses to pharmacological treatments. Collaborate with a multidisciplinary team to analyze data and present findings. Participate in patient consultations to provide pharmaceutical care and education. Maintain accurate records of patient interactions, trial results, and research activities. Stay updated with the latest advancements in pharmacology and related fields. Skills and Qualifications MBBS or MD degree with specialization in Pharmacology. Strong understanding of pharmacological principles and drug interactions. Experience with clinical trial protocols and data collection methodologies. Excellent communication skills to convey complex information to patients and team members. Ability to work collaboratively in a multidisciplinary team environment. Proficient in using statistical software for data analysis. Detail-oriented with strong organizational and documentation skills.

Summary As a Data Science expert, you will join our Modeling & Simulation Data Science team in the Translational Medicine Unit and help us to unleash the power of data science for drug discovery. You will bring your curious, innovative, and collaborative mindset to effectively harness the absorption, distribution, metabolism, excretion (ADME) and pharmacokinetics (PK) / pharmacodynamics (PD) data generated within our department and master the use of our in-house applications and state-of-the-art machine learning (ML) methods and statistical techniques to accelerate drug design. Our group is growing, and we hope you will join our dynamic, enthusiastic and forward-thinking team! About The Role Key responsibilities Your Responsibilities Will Include, But Are Not Limited To Act as the M&S Data Science representative on drug discovery and lead optimization programs by collaboratively contributing to project team discussions, using dry- and wet-lab data to provide scientific and strategic input to guide decisions such as compound progression and in vivo study prioritization Master and advocate the use of in silico models and in-house tools, applications and data to accelerate and streamline decision making Apply data mining to understand relationships between structure and molecular properties for programs involving small molecules, peptides, RNAs Identify opportunities to create custom, project- or modality-specific in silico models and data strategy, and contribute to their development and implementation Proactively seek opportunities to increase the impact and awareness of M&S Data Science through clear and concise communications with internal and external audiences or various expertise Monitor and stay up to date on developments within the field of AI/ML applied to ADME and PK/PD, and data science methods applied to drug discovery Role Requirements Essential requirements: Advanced degree in life sciences with multidisciplinary background (cheminformatics, bioinformatics, biomedical engineering, AI/ML in drug discovery or life sciences, data science, computational biology, computational chemistry or related field) PhD with 2+ years or MSc with 6+ years of relevant work experience with deep knowledge on drug discovery and development processes Experience in the application of (reproducible) data science methods, tools and practices to drug discovery Strong understanding of statistics, machine learning and deep learning Demonstrated knowledge of data visualization and exploratory analysis Solid skills in programming languages, i.e. Python and R, including software development practices such as version control, testing, documentation, etc. Knowledge of machine learning/deep learning libraries such as scikit-learn, keras or pytorch Excellent communication skills and ability to translate analytical concepts for diverse audience and stakeholders (English is our primary language) Desirable Expertise with discovery-stage PK modeling for small molecule compounds (e.g., relating ADME properties to in vivo PK; scaling of preclinical PK to human) is a plus Experience with generative algorithms and explainable AI Languages English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Role & responsibilities : Work as Pharmacokinetic and Scientific Affairs Personnel. 1. Provide feasibility inputs like study design, sample size estimation, sampling time points, wash out period, etc. 2. Review, evaluation and interpretation of PK/PD data from BA/BE studies-clinical trials and suggesting appropriate inputs in protocol and clinical study report 3. Review statistical report as per requirement. 4 Prepare and review statistical/pharmacokinetic analysis plan as per requirement 5. Archive and retrieval of data 6. Maintain and update feasibility database as per requirements 7. Maintain and assist regulatory query handling and tracking. 8. Provide impact assessment of PK related protocol deviations/Con-med assessment Preferred candidate profile: M. Pharma with min.1-2 years of relevant experience as PK Scientist in Clinical research (BA/BE studies). Job Location: Ahmedabad

We Are Hiring - International Sales Specialist – Life Sciences Online Education Experience: Minimum 6 to 8 Years Industry: Education / E-Learning / EdTech Joining: Immediate Joiners Preferred Company: YesM Pharma Job Description: We are a US-based online education provider offering specialized courses in Life Sciences, including Pharmacology, Pharmacokinetics & Pharmacodynamics, Signal Detection, Clinevo database training, and Clinical Trial Management. We are looking for a results-driven International Sales Specialist to promote our courses to foreign medical doctors and healthcare professionals. The ideal candidate should have a solid background in international education or healthcare sales, with an understanding of life sciences or medical training. Key Responsibilities: Drive international sales for online Life Sciences training programs Generate leads, pitch services, and convert prospects across the USA, UK, and Middle East markets Conduct virtual presentations and follow-ups with individual Build and maintain long-term relationships with foreign medical professionals and clients Maintain CRM and sales reporting tools with updated pipeline and progress Coordinate with academic and marketing teams for campaign execution Desired Candidate Profile: 6–8 years of international sales experience (preferably in education, training, or healthcare industry) Strong exposure to USA, UK, and Middle East markets Excellent English communication skills (spoken and written) – must be able to engage fluently with foreign clients Background in Life Sciences, Pharmacy, or Medical domain is a strong advantage Familiar with CRM tools and remote sales practices Must be comfortable working USA shift hours Only candidates with relevant international B2B/B2C sales experience will be considered. Mail CV - pankaj@marketingpanthers.com Show more Show less

Position You will play a critical role in ensuring the safe and effective use of medications for all patients at AHI. The role involves reviewing medication appropriateness, monitoring drug interactions, detecting and analyzing adverse drug reactions, and conducting prescription audits. You will work closely with physicians and other healthcare professionals to adjust doses, monitor restricted antibiotic use, and ensure compliance with hospital policies and standards such as JCI and NABH. Key Responsibilities Conduct daily morning rounds for all in-patient department (IPD) patients and review prescriptions in wards and ICUs before dispensing Lead the prescription audit team, ensuring thorough reviews and compliance with hospital policies Collaborate with doctors to adjust doses for patients with abnormal pharmacokinetics and pharmacodynamics, particularly in cases of renal and hepatic impairment Monitor restricted antibiotic use and coordinate with the infection control officer for the antibiotic stewardship program Prevent, anticipate, and investigate potential drug interactions and adverse drug reactions, presenting monthly reports on these issues to the quality department Monitor and implement the hospital’s narcotic policy, ensuring compliance Regularly check and verify the contents of crash carts and disaster kits Oversee blood sugar monitoring for all IPD patients and ensure timely incident reporting for any major incidents Provide daily reports on medication errors, adverse drug reactions, incomplete prescriptions, dispensing errors, and patient counseling sessions Ensure proper drug information is provided to both doctors and patients, with detailed counseling during patient discharge Conduct training sessions for ward and ICU pharmacists and nurses, keeping them up to date with clinical practices Coordinate and organize meetings for the Therapeutic Committee, maintain minutes, and follow up on action items Regularly update the hospital’s drug formulary, ensuring compliance with storage regulationsand monitor medication expiry dates Maintain room and refrigerator temperatures according to FDA regulations Monitor medication appropriateness, conducting audits, and ensuring safe and effective drug use according to JCI and NABH standards Qualifications Either Masters or Doctor of Pharmacy (Pharma D) is required Minimum 2 years experience About Asian Heart Institute Asian Heart Institute is India's #1 cardiac hospital dedicated to incorporating the latest technological advances and ethical practices to provide quality heart care at reasonable costs. As a JCI, NABH, and ISO-accredited hospital with a staggering success rate of 99.83% in bypass surgeries and an overall 99.4% in cardiac surgeries, we are considered among the best globally. Our foundation rests firmly on four core pillars: Ethics, Experience, Excellence, and Expertise. At the heart of our approach is a steadfast commitment to integrity and ethical practices, ensuring that every patient is treated with the highest level of respect and care. We take pride in our team of renowned experts, each contributing years of specialized experience and skill, which is pivotal in driving our pursuit of excellence. Our focus on expertise is not just about having the best professionals on board, but also about fostering continuous learning and staying ahead in our field. Powered by JazzHR UMXeBeKYEz Show more Show less

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description As part of the Clinical Development team at Azurity, the Clinical Development Manager, is primarily responsible for supporting departmental activities including but not limited to clinical trials (phase 1 to phase 4), conducting targeted scientific analyses for projects across therapeutic areas for nonclinical and clinical programs at Azurity. In this role, the candidate will report to the Associate Director, Clinical Development. Principle Responsibilities This should specifically outline, in bullet form, the responsibilities of the job: Ability to understand integrated data (formulation, pharmacokinetics/genomics, pharmacodynamics, pharmacovigilance, etc.) from clinical trials, treatment guidelines, and other resources to provide scientific evaluations and develop risk assessments. Provides operational and scientific oversight of nonclinical and clinical studies from study design to study closeout ensuring GCP/ICH/regulatory compliance of study documents, processes and procedures. Author study documents, including protocols, consents, management plans, amendments, etc. Review of CRO/3rd party documents (e.g., SOPs, CRFs, EDC, TFLs, etc.) to ensure alignment with Azurity’s quality expectations and SOPs, if needed. Drafting responses to competent authorities or ethical committees. Vendor and site monitoring. Identify logistical/scientific/ethical/regulatory hurdles/risks and propose solutions. Provide clinical updates on assigned programs. Identify key scientific sources/findings to support clinical development contributions to regulatory communications (e.g., meeting requests, briefing books, IND/NDA submissions, annual reports, etc.) Identify KOLs, external experts/consultants across diverse therapeutic areas to contribute to clinical development objectives. Draft abstracts, posters, oral presentations, and manuscripts. Contribute to process improvement initiatives within clinical development or in collaboration with other functions. Facilitate contractual requirements (CDAs, MSAs, etc.) for clinical development projects in collaboration with applicable Azurity functions. Collaborate with PM function to ensure visibility of project deliverables. Qualifications And Education Requirements This section should include relevant qualifications and education requirements. Degree in scientific/life-sciences field, Master’s degree preferred. 3+ years of experience in clinical development or related role within the pharmaceutical, biotechnology or CRO industry. Working knowledge of clinical research, GCP, GLP, ICH, and FDA regulations. Understanding of pharmaceutical drug lifecycle preferred. Strong communication skills (both written and verbal) with an ability to express complex information clearly and concisely. Exceptional analytical and problem-solving skills. Experience in analysis of research data and publications. Demonstrates passion for research and willingness to learn. Brings innovation and creativity to challenging projects. By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance. Show more Show less

Summary 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. About The Role 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 (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. Commitment to Diversity & Inclusion: : We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less