410 Drug Safety Jobs - Page 14

Conduct research and clinical trials in oncology, focusing on innovative cancer treatment methodologies. Work on drug development, biomarker discovery, and personalized medicine approaches. Collaborate with global research institutions and publish findings in peer-reviewed journals. Must have experience in molecular biology, genomics, and immunotherapy. Strong analytical and problem-solving skills are essential for data-driven decision-making in oncology research.

Conduct research and clinical trials in oncology, focusing on innovative cancer treatment methodologies. Work on drug development, biomarker discovery, and personalized medicine approaches. Collaborate with global research institutions and publish findings in peer-reviewed journals. Must have experience in molecular biology, genomics, and immunotherapy. Strong analytical and problem-solving skills are essential for data-driven decision-making in oncology research.

Job Purpose and Key Responsibilities: Provide support for Central Safety Department (CSD) literature screening activities for both ICSR and signal detection purposes in accordance with their procedures and regulatory requirements Support SERM product specialists by identifying articles of interest for relevant safety information from screened publications for all of GSK s product portfolio Perform PV literature surveillance activities according to appropriate regulations and agreed processes Ensure timely production of key deliverables including but not limited to: Screening and review of literature search results (articles/abstracts/citations) for purposes of ICSR identification Triaging literature search results for potential articles of interest with relevant safety information concerning both GSK marketed and GSK products in development, for signal detection/periodic reporting purposes using defined algorithms and criteria Accountability: Breadth/Scope of Accountability - Number of Direct Reports Number of Indirect Reports 0 0 Complexity (this is best illustrated for this role by the behaviors needed to perform effectively): Decision Making: Developing confidence in making decisions Makes decisions based on facts, common sense with the support of mentors or manager Understands and can articulate decision making process Teamwork: Works effectively with others to achieve business goals and objectives Bridges personal, business and cultural differences to work effectively in team settings Communication: Has effective communications with internal audiences, tailoring information appropriately Responds with confidence to more complex questions using sound judgment Translates complex science into simple messages that resonate Competencies: Minimum level of job-related experience required: 0 to 2 years of relevant industry experience Pharmaceutical industry experience (e g drug safety (desired), regulatory, clinical development, medical affairs) Working knowledge of key pharmacovigilance regulations and methodologies Good English language skills - written and verbal particularly in scientific/medical terminology Ability to evaluate data and draw conclusions with appropriate guidance from senior team members or manager Good attention to detail Good interpersonal, presentation and communication skills Service-oriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environment Computer proficiency, IT skills, the expertise and ability to work with web-based applications Good level of flexibility and ability to prioritize work Education: Minimum level of education: Bachelor s Degree - Life sciences (Biology, chemistry, pharmacy, medicine or other relevant scientific discipline) Preferred level of education: Pharmacy, Medical or pharmacology degrees

Alcon Laboratories (India) Pvt. Ltd is looking for Associate I Safety Data Analyst to join our dynamic team and embark on a rewarding career journey. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Preparation of operating budgets, financial statements, and reports. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processe

Jubilant Organosys is looking for Executive - Pharmacovigilance to join our dynamic team and embark on a rewarding career journey. Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processes.

Preparation & review of US ANDAs/ 505(b)(2)/EU/ Canada dossiers for Parenteral products as per regulatory requirements. Preparation & review of deficiency responses, regulatory strategy note, controlled correspondences, Briefing books, labeling, artworks and ScA meeting packages. Coordinate with internal stake holders (R&D, AR&D, SCM, FTO, CTO etc) and external counterparts (CMO & CRO) to review regulatory documents and proposals and provide strategic inputs. Identify all open issues at product development, ANDA filing and deficiency responses in consultation with team lead/RA vertical head. Provide support to commercial launch team w.r.t review progress and evaluate changes proposed for commercial batches (batch records, specifications, analytical method Stability protocols, PVPs etc).In coordination with eCTD / labeling team, ensure that the eCTD publication and Dossiers are filed according to regulatory guidelines. Qualification M. Pharm, M.Sc PhD Additional Information Good communication skill (Written and Oral), Self-starter with a go-getter attitude and team player, Quick learner and able to prioritize information, Good interpersonal skills, High level of proficiency in networking internally and externally.

Data Search & Analysis on the drug discovery and development Creating technology reports Kindly provide minimum two references with resume Required Candidate profile Keen interest in drug discovery, API Good Knowledge of organic chemistry Good Communication Skills

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Drug Safety ScientistDrug Safety Scientist Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Title Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Cardiologist - Medical Director to join our Core Labs in Mumbai office. This position will work in a team to accomplish tasks and projects that are instrumental to the company’s success. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Participate in oversight of assignments, training, and management of central reader s of cardiac imaging and EKG Collaborat e with Core Lab management on technical aspects of cardi ac study assessments Participat e in sponsor site visits and audits related to cardiac assessments as requested Participati e in training and subsequently demonstrating competency in the operation of independent central review of EKG and cardiac imaging for clinical trials Review protocols, Image Review Charters and associated clinical and technical study documents as required Complete source documents accurately and promptly, according to the specific protocol requirements and Medpace’s SOPs Blinded independent central review of EKG and cardiac imaging according to study endpoints as specified in clinical trial protocol, charter and according to GCP and standard Medpace SOPs Participate in IntraReader and InterReader variability assessments Participate in the development, review and evaluation of SOPs and study specific procedures. Other duties as assigned Qualifications Must have an M.D. and current medical licensure Board Certification preferred. Experience with EKG and most cardiac imaging modalities and expertise interpreting EKG, Holter-EKG and one or more cardiac imaging modality and therapeutic application Experience with various EKG and cardiac image analysis and viewing software (including PACS) Experience working with computer software including Word, Excel, Access and Project preferred Board Eligibility in Cardiology or equivalent training demonstrating competency People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets

We are seeking a dedicated and detail-oriented Executive in Pharmacovigilance to join our team in India. The ideal candidate will have experience in monitoring drug safety and ensuring compliance with regulatory requirements. Responsibilities Monitor and evaluate adverse drug reactions and safety data from various sources. Prepare and submit periodic safety reports to regulatory authorities. Collaborate with cross-functional teams to ensure compliance with pharmacovigilance regulations. Conduct signal detection and risk management activities. Maintain up-to-date knowledge of pharmacovigilance guidelines and best practices. Skills and Qualifications Bachelor's degree in Pharmacy, Life Sciences, or related field; Master's degree preferred. 3-8 years of experience in pharmacovigilance or drug safety. Strong knowledge of ICH/GCP guidelines and regulatory requirements. Proficiency in data analysis and interpretation of safety data. Excellent communication and interpersonal skills. Attention to detail and strong organizational skills.

Title Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Medical Writer to join our Core Labs in Mumbai office. This position will work in a team to accomplish tasks and projects that are instrumental to the company’s success. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities •Generate, revise, and maintain clinical documents; •Coordinate quality control of documents and maintain audit trail of reviews and changes; •Provide input on data analysis planning and its impact on clinical document outcome ; and •Performs other duties and responsibilities as assigned. Qualifications Master’s degree in a health or science-related field; Possess strong communication skills (oral and written); Intermediate knowledge of medical terminology and clinical patient management; People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets

Conduct research and clinical trials in oncology, focusing on innovative cancer treatment methodologies. Work on drug development, biomarker discovery, and personalized medicine approaches. Collaborate with global research institutions and publish findings in peer-reviewed journals. Must have experience in molecular biology, genomics, and immunotherapy. Strong analytical and problem-solving skills are essential for data-driven decision-making in oncology research.

Conduct research and clinical trials in oncology, focusing on innovative cancer treatment methodologies. Work on drug development, biomarker discovery, and personalized medicine approaches. Collaborate with global research institutions and publish findings in peer-reviewed journals. Must have experience in molecular biology, genomics, and immunotherapy. Strong analytical and problem-solving skills are essential for data-driven decision-making in oncology research.

Avron Hospitals Pvt. Ltd. is looking for Clinical Pharmacist to join our dynamic team and embark on a rewarding career journey. Compounding and dispensing medications, as prescribed by physicians. Monitoring customers drug therapies, advising interventions, and informing customers of any potential side effects. Instructing customers on how and when to take prescribed medications. Conducting health and wellness screenings. Providing immunizations, and other medical services, such as taking blood pressure, temperature measurements, and checking blood sugar levels. Keeping accurate customer records. Ensuring a safe and clean working environment. Completing operational requirements of the pharmacy, including verifying order entries, maintaining records of controlled substances, charges, and removing expired and/or damaged drugs from the pharmacys inventory. Adhering to applicable legal rules, regulations, and procedures governing pharmaceutical practice. Performing other administrative tasks when needed.

Ensure accurate dispensing, manage pharmacy inventory, maintain compliance (NABH/Drug Control), use HIS software, coordinate audits & procurement, support staff training. Strong drug knowledge & communication.Night shifts.Reg. State Pharmacy Council

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene s high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work Job Description: Act as SME for safety business and track industry trends relevant to safety Work in collaboration with the Sales and the Solutioning teams to improve win ratio and opportunity conversions Responsible for improving capability presentations and Identifying service areas and solutions and work with the operational leadership to build capabilities Participates in the analysis and definition of efficient, cost effective and creative solutions deliver competitive value propositions to the industry Build partnership with senior leadership across the industry in Safety and PV Represent the company in trade conferences, speaker sessions etc. Identify and build potentially synergistic partnerships to expand client and service footprints Be part of safety consulting engagements as well as provide oversight and expertise on operations as needed Must Have - MBBS/ MD with a minimum of 8-10 years of experience in drug safety or a related field; Master/Diploma in Management degree is added advantage - Experience in the pharmaceutical industry, preferably in drug safety, pharmacovigilance, or clinical development - Knowledge of pharmacology, toxicology, and clinical trial methodology - Understanding of FDA and international regulatory requirements related to drug safety and pharmacovigilance - Strong analytical and problem-solving skills - Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams - Demonstrated ability to prioritize tasks and manage multiple projects simultaneously - Proficiency in data analysis tools (e.g., Excel, SAS) and safety databases (e.g., Argus, ARISg) - Good communication skils and relationship building skills - Act as SME for safety business and track industry trends relevant to safety - Work in collaboration with the Sales and the Solutioning teams to improve win ratio and opportunity conversions - Responsible for improving capability presentations and Identifying service areas and solutions and work with the operational leadership to build capabilities - Participates in the analysis and definition of efficient, cost effective and creative solutions deliver competitive value propositions to the industry - Build partnership with senior leadership across the industry in Safety and PV - Represent the company in trade conferences, speaker sessions etc. - Identify and build potentially synergistic partnerships to expand client and service footprints - Be part of safety consulting engagements as well as provide oversight and expertise on operations as needed Good to have EQUAL OPPORTUNITY

Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines Processing literature, spontaneous clinical trial and solicited cases Responsible for coding events, indications and patient history based on MEDDRA Required Candidate profile EDUCATION: M.Pharm/Pharm D/Life sciences / Microbiology / Biotech /Biochem /Nursing / BDS EXPERIENCE: Strong Knowledge in pharmacovigilance With Certification or its equivalent.

Role & responsibilities: Ensures that qualified by education, training, and experience to assume responsibility for the proper conduct of the clinical studies. Maintaining current, up-to-date curriculum vitae . Assuming responsibility for the conduct of the clinical investigation. Signing the protocol Documenting the financial aspects of the trial. Disclosing conflicts of interest as described in the regulations. Ensuring adequate number of qualified staff and adequate facilities for conductance of the study properly and safely. Ensures that all persons assisting with the study are adequately informed about the protocol, the investigational product(s), and their study-related duties and functions. Ensuring that medical care is provided to a subject for any adverse event(s) that is reported. Informing a subject when medical care is needed to treat an inter-current illness. Provide information regarding adverse events and serious adverse events to the IRB/IEC. Possessing a thorough understanding of the requirements of each protocol . Ensuring recruitment goals are reasonable and attainable. Assessing overall protocol feasibility. Following the trials randomization procedures. Ensuring that the informed consent form contains the entire Essential and additional elements required. Conduct of the clinical studies specified by the applicable regulatory requirement(s), the IRB/IEC requirements and/or the regulatory authorities. Conduct the study as per the principles of ethics and is compliance with Good Clinical Practices (GCP). Attending education workshops. Reviewing professional publications. Participating in professional societies Maintaining a list of qualified persons and their corresponding trial-related delegated duties. Preferred candidate profile can send to email: hr@qpsbioserve.com or raghavendra.kundhula@qpsbioserve.com Perks and benefits: Nil

We are looking for a highly skilled and experienced Branch Receivable Manager to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 3 to 8 years of experience in the BFSI industry, with expertise in managing receivables and driving business growth. Roles and Responsibility Manage and oversee the daily operations of the branch's receivable functions. Develop and implement strategies to improve collection efficiency and reduce delinquencies. Collaborate with cross-functional teams to identify and mitigate potential risks. Analyze and report on key performance indicators (KPIs) related to receivables and collections. Ensure compliance with regulatory requirements and internal policies. Lead and motivate a team of professionals to achieve business objectives. Job Requirements Strong knowledge of BFSI regulations and practices. Proven experience in managing receivables and driving business growth. Excellent leadership and communication skills. Ability to analyze complex data sets and make informed decisions. Strong problem-solving and negotiation skills. Experience working in a fast-paced environment and meeting deadlines.

RoleClinical & Therapy Development Manager Type Full Time Job description - Successfully complete our internal training plan to include hemodynamics, ECG, angiography, echo CT imaging modalities and complete the case support and proctor delegate authorizations. - Provide active commercial case support, demonstrating excellence in procedural success rates patient outcomes. - Scrub in sterile and provide TAVI valve loading in procedures training instruction to trial and commercial customers - Provide our customers CT valve sizing analysis utilizing the Pie Medical 3Mensio CT program - Lead customer didactic education sessions for account activation before first implants - Lead pre case planning debriefing of heart team pre post procedure and provide ongoing education as requested for proper in - service levels - Provide documentation as required for quality assurance initiatives - Co-develop commercial business plan for assigned region - Co-support internal/external quarterly business reviews - Data entry into Salesforce, Mentor software for customer case support management - Learn commercial data analytics, resources tools for effective customer experience - Support customer engagement strategy with Marketing team (TM)) - Demonstrate competency with marketing messaging, clinical evidence and medical education portfolio offering - Demonstrate knowledge in the TAVI market, industry competitive insights - Participate in team meetings, conventions, and national sales meetings as requested - Drive innovative marketing and referral activities in collaboration with the markeitng team - Collaborate with the Sales and marketing team to conduct targeted market development in India Sub-continent. - Lead organization and delivery of key symposia by supporting discussions with customers to define agenda topics, select appropriate speakers / chairs, create required materials for events. - Develop Key Opinion Leaders within this segment to create market for the new therapies which will be launched and create advocates for your product who will speak on various forums - Identify high potential international / national referral community meetings to target for market development and collaborates with sales management team to put forward case for investment (program contributions / symposiums / workshops) This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

We are looking for a highly motivated and experienced Branch Operations Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2 to 7 years of experience in the BFSI industry. Roles and Responsibility Manage daily branch operations, ensuring efficient workflow and customer satisfaction. Supervise and coordinate with branch staff to achieve operational goals. Develop and implement strategies to improve branch performance and productivity. Maintain high standards of customer service, resolving complaints and queries promptly. Ensure compliance with regulatory requirements and internal policies. Analyze operational data to identify areas for improvement and optimize processes. Job Requirements Minimum 2 years of experience in branch operations or a related field. Strong knowledge of BFSI operations, regulations, and procedures. Excellent communication, leadership, and problem-solving skills. Ability to work in a fast-paced environment, prioritizing tasks effectively. Proficient in Microsoft Office and other operational software. Strong analytical and decision-making skills with attention to detail.

Job Title: Senior Scientist - In Vitro Secondary Pharmacology Career Level: D Introduction to role: Are you ready to make a significant impact in the world of drug discovery and developmentJoin AstraZenecas Clinical Pharmacology Safety Sciences (CPSS) department, where innovation meets collaboration. Our Safety Innovation team is at the forefront of advancing a diverse pipeline across therapeutic areas, delivering safety science from early discovery through clinical development. We are seeking a talented in vitro pharmacologist to join our Secondary Pharmacology team, contributing to the clinical advancement of new medicines. Accountabilities: In this pivotal role, youll leverage your expertise in pharmacology, toxicology, and biology to collaborate with drug safety specialists and project safety pharmacologists. Your insights will shape drug design during the early phases of discovery, ensuring the selection of safer molecules and developing strategies to mitigate safety risks. Youll generate in vitro pharmacological profiling data at contract research organizations (CROs), identify off-target risks, and interpret pharmacological interactions. Your work will translate in vitro activity into pre-clinical and clinical adverse events, providing crucial guidance for project decisions. Essential Skills/Experience: PhD or Masters or equivalent experience in a relevant scientific field with 4+ years of industrial experience. A strong background in pharmacology (e.g., pharmacology, biology, biochemistry, toxicology, physiology) with a proven track record in driving innovative science, preferably in the pharmaceutical or biotechnology industry. Technical experience in in vitro pharmacological or biochemical assay development and screening (e.g., kinase profiling technologies, radioligand binding, enzyme activity, and functional cell-based systems) applied to various biological target classes. Excellent problem-solving and organisational skills, delivery focus, and outstanding communication skills. A true collaborator with highly effective networking skills and experience collaborating across scientific disciplines, cultures, and expertise. Desirable Skills/Experience: Experience with off-target profiling data and strategies in the pharmaceutical industry. Practical understanding of kinase profiling technologies. Experience working with CRO s, commissioning requests and driving delivery processes. Experience with being entrepreneurial taking the initiative in projects. Demonstrated leadership in scientific projects or teams. Experience in regulatory interactions or safety assessments. Knowledge of emerging trends in drug safety and pharmacovigilance. At AstraZeneca, we are driven by curiosity and courage, exploring what science can achieve. Our commitment to making a difference is unwavering as we fuse data and technology with scientific innovation to tackle some of the worlds most complex diseases. We celebrate successes and learn from failures, creating an inclusive environment where diverse knowledge is leveraged for swift impact on disease. With opportunities for lifelong learning and career growth, AstraZeneca is where you can push boundaries and deliver life-changing medicines. Ready to make a differenceApply now and be part of a team that transforms patient lives through groundbreaking science! Date Posted 23-May-2025 Closing Date 03-Jun-2025

We are looking for a Life Science Senior Content Specialist to join our team in Hyderabad/Noida . This is an amazing opportunity to work on OFF-X, a translational drug safety intelligence portal . The team consists of 20 people located in Spain and India and is reporting to the India-based Team Manager. We have a great skill set in the analysis of drug safety and toxicity data and we would love to speak with you if you have skills in that area About You - experience, education, skills, and accomplishments Degree in Life Sciences (Pharmacy, Pharmacology, Toxicology, Biology, Biomedical Sciences, etc.) Min 5 years of experience in drug safety, toxicology, pharmacovigilance Excellent English written and oral communication skills Attention to detail, results orientated, enthusiastic, determined to achieve and shows commitment It would be great if you also had . . . Ability to analyze large volumes of structured or unstructured data. Ability to delve deep into content and results. Interpersonal skills and the ability to work independently and collaboratively with a team Self-starter with the ability to multitask and prioritize across projects to meet deadlines Good skills of problem-solving and good judgment in decision-making and setting priorities. What will you be doing in this role Selection of appropriate scientific articles and conference content for the project. Analysis and interpretation of published data (clinical trials, journal articles, reviews, meta-analysis, congress communications, drug approval reports, etc.) Collection and curation of information on risks and safety of drug products (recording, archiving, updating and evaluating the information) Writing case studies, reports and reviews Maintain informed discussions with experts and customers About the Team Our editorial team is a group of 20 people creating and delivering content for OFF-X, a translational drug safety intelligence portal that allows user to easily identify new safety liabilities. We are a global team based on India and Spain with more than 50 years of experience in the sector. We create and classify content for more than 300 references every week, including Journals, Congress publications and Regulatory documents. In this team you will have the opportunity to be up-to-date with all the new advances in the drug development industry and you will be constantly learning new things. Location - Hyderabad / Noida

The Associate Medical Expert in TCO (Translational Clinical Oncology), is the medical leader for assigned global, roll-over and long-term follow-up studies, and studies in the close-out phase. They may also provide medical support for assigned aspects of a global, active, TCO study, under the leadership of a Clinical Program Leader (CPL) and / or Medical Expert TCO (Translational Clinical Oncology) is a department under Biomedical Research division, and is responsible for designing and executing out early phase (first in human) clinical studies in patients with cancer. It acts as a bridge between drug discovery and late phase clinical development and strives to deliver transformative new medicines for oncology conditions. About the Role Major accountabilities: Provides medical support to Clinical Program Leader (CPL) and / or Medical Expert. Medical support may include, but is not limited to, contributing to clinical sections of protocols and/or amendments, Informed Consents, publications, regulatory documents such as Investigator Brochures, responses to Health Authority questions and conducting ongoing review of clinical trial data, with oversight of TCO deliverables. May act as the medical monitor to support overall program safety reporting (eg, Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety Team. Contributes to clinical/scientific elements of TCO - related submission documents, including preparation and review of project documentation for Health Authority submission, including briefing books, IBs, Annual Safety Reports, responses to Health Authority questions etc Contributes to the ongoing clinical trial data medical/scientific review across assigned TCO studies and coordinates data analysis and interpretation Supports conduct of dose escalation meetings, investigator teleconferences and site initiation visits etc Accountable for assigned close-out, roll-over and long-term follow-up studies, ensuring Clinical Study Report review, consistency and quality of clinical study reports (CSR) in collaboration with CSR medical writing team, and publication of studies across assigned TCO projects - either directly as lead author or by providing leadership to the medical writing team Maintains expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies. Advocate continuous improvement of quality Key performance indicators: Evidence of high-quality medical input to assigned studies to ensure execution according to timelines and ensuring adherence to international and local regulations. Evidence of quality medical and scientific review of clinical trial data Demonstrates excellent scientific writing skills to enable the development of high-quality documents including but not limited to clinical trial protocols, trial reporting (eg CSR), and regulatory documents (eg IB, DSUR). Contribution towards objectives set for the department. Feedback from external and internal stakeholders. Clearly demonstrates Novartis Values and Behaviors. Minimum Requirements: MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (eg, internal medicine / pharmacology etc) with medical council certification required. Experience in hematology / oncology preferred. Work Experience: At least 2 years of pharmaceutical/biotech industry experience or at least 4 years of clinical practice experience in the hospital setting Knowledge of Good Clinical Practice (GCP). Strong operational project experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities. Demonstrated operational excellence and scientific contribution to clinical or preclinical projects. Clear written and verbal expression of ideas, an active/proactive communicator. we'll-developed interpersonal skills, with a proven record of accomplishment of successfully interacting with, influencing and building strong positive relationships. Used to working independently and in a team, being flexible and adapting in a changing environment. Skills: Clinical Monitoring. Clinical Research. Clinical Trial Protocol. Clinical Trials. Decision Making Skills. Drug Development. Health Sciences. Lifesciences. Regulatory Compliance. Languages : English.

As a Principal Scientist I within Preclinical Safety (PCS) Pathology Team, you will be responsible for advancing translational safety omics data analysis to support innovative drug discovery development efforts. The candidate will participate in the study design, analysis, interpretation, and presentation of the data by interacting closely with a team of pathologists, bench scientists, and subject matter experts across the sites (eg USA, Switzerland) of Novartis. The role requires significant omics-based data science expertise and a passion to elevate the role of multimodal data analysis in translational drug safety. About the Role Your responsibilities include, but are not limited to: Use machine learning and statistical methods for analysis of spatial transcriptomics (eg Visium/Nanostring platforms) and spatial proteomics data (both internal and public data) from raw reads Compare and contrast spatial omics data sets with bulk RNASeq and single cell data Multimodal analysis of omics data with other modalities such as histopathology images, clinical biomarkers, etc Support projects with data science expertise in diverse scientific fields such as gene and cell therapy, target discovery, genetics, drug safety, compound screening, etc Innovate by transforming the way to solve a problem using Data Science Artificial Intelligence Communicating regularly with stakeholders and assisting with answering their questions with the data and analytics Proactively evaluate the need of technology and novel scientific software, visualization tools and new approaches to computation to increase efficiency and quality of the Novartis data sciences approaches Independently identifies research articles and reproduce/apply methodology to Novartis business problems M.S. or PhD in Data Science, Computational Biology, Bioinformatics, or a related discipline Proficient in programming languages and data science workflows (eg Python, R, Git, UNIX command line, high-performance computing (HPC) clusters etc) A minimum of 5 years of experience in analyzing large biological datasets (genomics, proteomics, and transcriptomics data analysis and data-integration) in a drug discovery/development or relevant academic setting Proven ability to implement exploratory data analysis and statistical inference in the context of scientific research A collaborative, team-focused mindset coupled with outstanding communication skills, and the ability to work in an agile environment Experience with using machine learning algorithms to extract insights from complex datasets Familiarity with the concepts of molecular biology, cell biology, genomics, biostatistics and toxicology