1120 Clinical Research Jobs - Page 44

Develop and maintain interactions with Thought Leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions. MSLs will use various channels for interactions (1:1, group presentation; remote, etc). Develop and execute a medical interaction plan with Key accounts (Army, Railways, CGHS etc.) as per the needs of the stakeholders and the overall medical strategy. Effectively present information to HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives. Actively assess the medical landscape by meeting with Thought Leaders to understand their needs and expertise. Continuously update their own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers. Collect and provide meaningful medical insights back to the medical and commercial organizations to be actioned in support of the strategy development. Report safety information, including adverse events, in accordance with BMS Standard Operating Procedures. Contribute to the Country Medical Plan Develop territory Field Medical plan and TL Interaction plans based on therapeutic area objectives and TLs needs. Execute certain medical plan activities as assigned. Adopt institution/account planning approach and contribute to cross-functional institution/account plans. Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan. Provide Medical Support As necessary and appropriate, support the initial and ongoing medical/scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Market Access). Provide scientific support at promotional meetings by presenting unbiased scientific and clinical data, by evaluating speakers and by giving support to BMS-contracted speakers. Support Clinical Trial Activities Support Interventional and Non-Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to support patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with local medical management and as defined by the study scope document. Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with local medical management. Actively support CRO sponsored studies as agreed with local medical management and as defined by the study scope document. Support HCPs in the ISR submission process as agreed with local medical management. Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events. Contribute towards the Patient advocacy programs Support the implementation of the patient education programs in collaboration with the patient advocacy groups. Support the creation of patient education materials. Report safety information, including adverse events, in accordance with BMS Standard Operating Procedures Qualifications MBBS, MD, BDS, MDS 1-2 years of Field Medical experience in medical affairs is preferred. Candidates with experience in the Oncology and Haematology therapy area will be preferred. Languages Excellent English language skills - spoken and written. Experience And Knowledge Working in a scientific and/or clinical research environment Ability to work independently and act as a team player. Have an innovative mindset and approach. Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients. Good communication and presentation skills to present scientific and/or clinical data to research or healthcare professionals Developing peer-to-peer relationships with TLs, scientists and other healthcare professionals Ability to quickly and comprehensively learn about new subject areas and environments. Disease area knowledge and an understanding of scientific publications Knowledge of clinical trial design and process Knowledge of the national healthcare and access environment Knowledge of HEOR core concepts (Health economic and outcome research) is a plus.

Fresher Hiring 2023 - 2025 Passouts only - All India Qualification - B.Pharm, M.Pharm, B.SC, M.SC, Life Sciences Graduates & Post Graduates Medical - BDS, BHMS, BAMS, MBBS Role & responsibilities Perform data reconciliation between different data sources and study documents to ensure data integrity and consistency across datasets. Generate data queries to address discrepancies, inconsistencies, and missing data identified during data review, ensuring timely resolution and documentation of data queries Communicate data queries to investigative sites, data managers, and study personnel, following up on query responses and resolving discrepancies in collaboration with relevant stakeholders Identify deviations from protocol-specified procedures, eligibility criteria, and data collection guidelines, escalating issues to appropriate personnel for resolution Perform quality checks and data validation procedures to ensure accuracy, consistency, and reliability of clinical trial data, adhering to data management standards and industry best practices Assist in the development and implementation of data validation plans, data review guidelines, and quality control procedures to maintain high standards of data quality and integrity. Assist in a variety of specialties including but not limited to primary care, orthopedics, rheumatology, etc. Updates patient history, physical exam, and other pertinent health information in the document as required. Complies with Compliance standards of the Organization as laid by HIPAA. Performs other duties and tasks to improve provider productivity and workflow as assigned by supervisors. Assist documenting the patients, electronic health record (EHR). Fresher Hiring - Pharma / Life Sciences / Medical Qualification - B.Pharm, M.Pharm, B.SC, M.SC, Life Sciences Graduates & Post Graduates Medical - BDS, BHMS, BAMS, MBBS Location - All India - Delhi, Mumbai, Pune, Bangalore, Kochi, Chennai, Hyderabad, Ahmedabad, Bhopal, Indore, Kolkata, Chandigarh

Job Overview Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision. Essential Functions Acts as a Regulatory Team Leader on more complex projects, which may include technical writing; Prepares and/or reviews regulatory documentation in area of expertise, as appropriate; Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments; Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable; Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate; May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development; May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person; May act as reviewer for regulatory standard operating procedures, as assigned and appropriate; May prepare and deliver regulatory training to IQVIA small groups or individuals; Performs other tasks or assignments, as delegated by Regulatory management; Qualifications Bachelors Degree Degree in Lifescience or related discipline Req Or Masters Degree Degree in Lifescience or related discipline Req At least 3-4 years relevant experience Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate; Possesses a specific regulatory or technical expertise; Good, solid interpersonal communication (oral and written) and organisation skills; Ability to establish and maintain effective working relationships with coworkers, managers and clients; Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable; Demonstrates self-motivation and enthusiasm; Ability to work on several projects, with direction from senior staff as appropriate; Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements; Ability to make decisions on discrete tasks under senior supervision; Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education; Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area; Problems faced are general and may require understanding of broader set of issues, but typically are not complex; Ability to adapt quickly to a rapidly changing environment; Applicable certifications and licenses as required by country, state, and/or other regulatory bodies . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Job Overview Under general direction, manage all laboratory aspects of assigned clinical trial projects for a Customer or a specific program for a Customer. May have responsibility for a specific Customer, drug program, indication or drug compound. Acts as the main point of contact for the Customer after study award and throughout the entire study lifecycle (startup, maintenance, closeout). Ensures work is conducted in line with standard operating procedures, policies and good practices. Essential Functions Study Setup and Planning: Facilitate seamless study set-up including Protocol and Budget review, leading meetings, develop and implement project plans, milestone, risk, issue and action logs. Partner with Study Setup team to ensure quality database set-up, oversee preparation of protocol specific documentation. Will prepare and present protocol-specific materials at Kick Off and Investigator meetings May participate in the proposal and business development process including bid defence meetings. Support development of Customer standards Study Activity Monitoring and Closeout: Will monitor the Project Management Plan, timelines and deliverables, manage study documentation throughout the Project lifecycle including filing into eTMF, oversee study monitoring and reporting, conduct meetings to meet needs of the Study and Customer requirements Will manage study scope changes and budget monitor quality of the study and any service-related issues, implementing changes as required. Lessons learnt will be reviewed and shared Proactive Lines of Communication: Build and own the Customer relationship, facilitate communication, collaborate with all operational areas within the company Will serve as an escalation point for study level issues and will coordinate and triage study-specific issues Coordinates customer survey follow up and ongoing health checks to support Customer relationship building Meetings, Initiatives and Training Activities: Will represent the company at Investigator meetings and other internal / external face to face meetings. Will participate in audits and inspections as required Will provide study training to sites, CRAs and customers Will establish regular lines of communication with sites to manage on-going project expectations and issues. Will participate in improvement projects as needed Will assist in training of less experienced staff. Qualifications Bachelors Degree Life Sciences and/or related field Pref Or Other Equivalent combination of education, training and experience may be accepted in lieu of degree. 2+ years of clinical or research industry experience, including 1 year project management / project set up experience Pref Or Equivalent combination of education, training and experience Strong interpersonal and customer management skills. Working understanding of medical and clinical research terminology. Working knowledge of Project Management processes, the company laboratory processes, and/or equivalent working knowledge of central laboratory operations (kits/supplies, logistics, laboratory operations, specimen storage, data reporting and transfers, site alerts, etc.) preferred. Demonstrated computer proficiency with Microsoft Office and the company systems, or equivalent experience with similar Centralized Laboratory systems preferred. Experience in successfully leading Phase I-IV clinical trials preferred. Demonstrated ability to work in a fast-paced environment while possessing strong organizational skills and a demonstrated ability to meet deadlines. Strong written and verbal communication skills including good command of English language. In certain geographies where communication in local language is desired (e.g. Japan, China), excellent command of local language with reasonable proficiency in English preferred. Ability to establish and maintain effective working relationships with coworkers, managers and customers. . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Job Overview Independently manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, Customer Site Manager, and/or a leadership role in a specific CDM task (e.g. Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents. Essential Functions Client Management: Serve as primary point of contact for customer on data management deliverables manage multiple large studies or program of studies (possibly global) Provide leadership and senior support to DTLs on multiple large global studies/programme of global studies Provide leadership and senior support to DTLs on multiple large global studies/programme of global studies. Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise Lead direct negotiations with customer, e.g., timelines, financial, process, resources. Maintain strong customer relationships Ensure open communications with customer and IQVIA management to independently manage and meet contractual obligations Service Management: Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables provide training and development on data management expertise to junior team members Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects Serve as the escalation point for unresolved data issues independently work with client data managers, vendors, internal team members for resolution Ensure appropriate resources are assigned to meet project deliverables Create and/or review and sign-off on all data management plan (DMP) documents Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW Implement proactive quality management plans across multiple projects/programmes/customer account. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions Continuously look for opportunities to improve service develop and work with team to implement plan to re-organise and drive change (possibly across a customer account) Ensure timely follow-up and resolution of compliance issues Serve as Subject Matter Expert (SME) Provide leadership and expertise in a specific CDM task or technology Serve as customer site lead for one or more customers Train and mentor junior DTL staff in DM expertise may coordinate the work of more junior DTL staff Independently maintain internal tracking databases and systems Financial Management/Business Development Support: Independently manage SOW/budget Review financial reports on a monthly basis and participate in project reviews as requested Identify out of scope tasks and track change orders to completion Participate in pricing discussions across customer account Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing Independently support RFP process (review RFP documents, pricing, attend bid defense) Other: Independently bring process improvements and solutions to the CDM team/CDM department Lead a focus team or global or local best practice team Communicate lessons learned and/or present in CDM workshop(s) Manage the development and implementation of new technology or tool Present at professional conferences and/or publish articles in professional journals Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions Perform other duties as directed by the functional manager Qualifications Bachelors Degree Health, clinical, biological or mathematical sciences, or related field Req 5 years of direct Data Management experience with 3 or more years as a CDM project lead Pref Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients). Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology). Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently. Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Knowledge of Good Clinical Practices and relevant regulatory guidelines. Excellent communication, interpersonal, customer service, and teamwork skills. Excellent organizational and problem-solving skills. Excellent project management skills. Ability to work independently. Comprehensive understanding of clinical drug development process. Ability to establish and maintain effective working relationships with coworkers, managers and customers. Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients). Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology). Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently. Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Knowledge of Good Clinical Practices and relevant regulatory guidelines. Excellent communication, interpersonal, customer service, and teamwork skills. Excellent organizational and problem-solving skills. Excellent project management skills. Ability to work independently. Comprehensive understanding of clinical drug development process. Ability to establish and maintain effective working relationships with coworkers, managers and customers. . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Senior Accounts Receivable Associate - India, Chennai - Hybrid, Office-Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Accounts Receivable Associate to join our diverse and dynamic team. As a Senior Accounts Receivable Associate at ICON, you will play a crucial role in managing and optimizing the accounts receivable processes to ensure the timely and accurate collection of payments. You will contribute to maintaining financial health by overseeing invoicing, collections, and customer account management. What You Will Be Doing: Managing the accounts receivable process, including invoicing, payment collection, and account reconciliation. Collaborating with cross-functional teams to resolve any billing issues or discrepancies and ensure accurate financial transactions. Overseeing the review and analysis of accounts receivable aging reports to identify and address outstanding balances. Providing support and guidance on accounts receivable policies and procedures to ensure compliance and efficiency. Building and maintaining positive relationships with clients and internal stakeholders to facilitate smooth financial operations. Your Profile: Bachelor s degree in Accounting, Finance, or a related field. Proven experience in accounts receivable or a similar financial role, with a strong understanding of invoicing and collections processes. Excellent organizational skills and attention to detail, with the ability to manage multiple tasks and meet deadlines. Strong communication skills, with the ability to effectively interact with clients and internal teams. Proficiency in accounting software and Microsoft Office, particularly Excel, with the ability to analyze financial data and generate reports. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

CDC II _ Office based (Hybrid) ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Data Coordinator II to join our diverse and dynamic team. As a Clinical Data Coordinator II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing Assist Data Management Study Lead in maintenance of eCRF, Data Validation Specifications, and Study Specific Procedures. Manage clinical and third-party data reconciliation based on edit specifications and data review plans. Tracks and communicates status of study and task metrics to clinical data scientist, project team, and functional management. Address data related questions and recommend potential solutions. Identify root cause to systematically resolve data issues. Your profile Bachelors degree in a relevant field, such as Life Sciences or Healthcare. Intermediate knowledge of clinical data management within the pharmaceutical or biotechnology industry. Familiarity with data management software and systems (e.g., Medidata, Oracle RDC, or similar). Strong attention to detail and the ability to work effectively in a fast-paced environment. Excellent communication skills and the ability to collaborate with cross-functional teams. Knowledge of regulatory guidelines and standards (e.g., ICH-GCP) is a plus. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

Biostatistician I / II - India - Office Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Biostatistician I to join our diverse and dynamic team. As a Biostatistician II at ICON, you will play a pivotal role coordinating and supervising the work of biostatisticians and programmers, ensuring timely and high-quality deliverables for assigned studies. What you will be doing: Contribute to the design of case report forms with a focus on statistical aspects. Review study database structures, edit checks, and data management coding conventions to ensure data integrity. Prepare comprehensive statistical analysis plans, defining derived data and crafting statistical tables, figures, and data listings for clinical summary reports. Conduct statistical analyses to extract meaningful insights from research data. Interpret data and effectively communicate findings through result reporting. Collaborate on writing the statistical methods sections of integrated study reports. Your Profile: A Masters degree or higher in statistics or related field Demonstrated experience of 2+ years in statistics, biostatistics, or a related field within the pharmaceutical industry is required. Strong kNwledge of study designs and statistical analysis conventions in one or more therapeutic areas. Exceptional verbal and written communication skills and proficient computer skills. Strong familiarity with clinical trials methodology, regulatory requirements, statistics, and proficiency in statistical software packages, including SAS. Ability to translate clients needs into statistical practices and educate clients in the utilization of statistical methods, coupled with solid interpersonal and project management skills. #LI-KT1 What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

In this Role you will be Responsible for The coder reads the documentation to understand the patient's diagnoses assigned. Transforming of healthcare diagnosis, procedures, medical services, and equipment into universal medical alphanumeric codes Creating uniform vocabulary for describing the causes of injury, illness & death is the role of medical coders. Medical coding allows for Uniform documentation between medical facilities. The main task of a medical coders is to review clinical statements and assign standard Codes Requirements of the role include 1 Year of experience in any Healthcare BPO - University degree or equivalent that required 3+ years of formal studies in Life science/BPT/Pharm/Nursing Good knowledge in human Anatomy/Physiology Experience using a computer with Windows PC applications that required you to use a keyboard, navigate screens, and learn new software tools. Ability to work scheduled shifts from Monday-Friday 7:30 AM to 5:30 PM IST and the shift timings can be changed as per client requirements. Flexibility to accommodate overtime and work on weekend basis business requirements. Need to return to office when NTT Data provides communication related to that.During training you will be asked to work from office * Career Arch Job code Overview and General duties and tasks For Internal Reference Only

In these roles, you will be responsible for The coder reads the documentation to understand the patient's diagnoses assigned Transforming of healthcare diagnosis, procedures, medical services, and equipment into universal medical alphanumeric codes Creating uniform vocabulary for describing the causes of injury, illness & death is the role of medical coders Medical coding allows for Uniform documentation between medical facilities The main task of a medical coders is to review clinical statements and assign standard Codes Coding and abstracting information from provider patient medical records and hospital ancillary records per facility and/or state requirements. Following strict coding guidelines within established productivity standards. Attending meetings and in-service training to enhance coding knowledge, compliance skills, and maintenance of credentials. Maintaining patient confidentiality. Required Skills for this role include 4 + years of experience working with CPT and ICD-10 coding principles, governmental regulations, protocols and third party requirements regarding medical billing. Coding certification is Mandatory, should have exposure in Radiology Should have experience in auditing and should play an mentor role for freshers 1+ year(s) of experience using a computer with Windows PC applications that required you to use a keyboard, navigate screens, and learn new software tools. Ability to work scheduled shifts from Monday-Friday 7:30 AM to 5:30 PM IST and the shift timings can be changed as per client requirements. Flexibility to accommodate overtime and work on weekend’s basis business requirement. Ability to communicate (oral/written) effectively in English to exchange information with our client

In this Role you will be Responsible For The coder reads the documentation to understand the patient's diagnoses assigned Transforming of healthcare diagnosis, procedures, medical services, and equipment into universal medical alphanumeric codes Creating uniform vocabulary for describing the causes of injury, illness & death is the role of medical coders Medical coding allows for Uniform documentation between medical facilities The main task of a medical coders is to review clinical statements and assign standard Codes Requirements of the role include 0 -1 Year of experience in any Healthcare BPO University degree or equivalent that required 3+ years of formal studies in Life science/BPT/Pharm/Nursing Good knowledge in human Anatomy/Physiology 1+ year(s) of experience using a computer with Windows PC applications that required you to use a keyboard, navigate screens, and learn new software tools Ability to work scheduled shifts from Monday-Friday 7:30 AM to 5:30 PM IST and the shift timings can be changed as per client requirements. Flexibility to accommodate overtime and work on weekend’s basis business requirement. Ability to communicate (oral/written) effectively in English to exchange information with our client

In this Role you will be Responsible for Should have experience in Radiology coding The coder reads the documentation to understand the patient's diagnoses assigned. Transforming of healthcare diagnosis, procedures, medical services, and equipment into universal medical alphanumeric codes Creating uniform vocabulary for describing the causes of injury, illness & death is the role of medical coders. Medical coding allows for Uniform documentation between medical facilities. The main task of a medical coders is to review clinical statements and assign standard Codes Requirements of the role include 1 Year of experience in any Healthcare BPO - University degree or equivalent that required 3+ years of formal studies in Life science/BPT/Pharm/Nursing Good knowledge in human Anatomy/Physiology 1+ year(s) of experience using a computer with Windows PC applications that required you to use a keyboard, navigate screens, and learn new software tools. Ability to work scheduled shifts from Monday-Friday 7:30 AM to 5:30 PM IST and the shift timings can be changed as per client requirements. Flexibility to accommodate overtime and work on weekend basis business requirements. It is Mandatory to return to office based on client or business requirement.

Global HEOR Value Writing Leader What you will do Let’s do this. Let’s change the world. In this vital role you will serve as the operational head for a team of Global HEOR Value Writers (L5) supporting Amgen’s global market access and reimbursement. This role is accountable for ensuring the timely and high-quality development of payer- and HTA-relevant deliverables including Global Value Dossiers (GVDs), AMCP dossiers, early HTA briefing books, reports and scientific publications across multiple therapeutic areas. The Global HEOR Value Writing Leader aligns closely with the Global Head HTA Strategy & Project Management and the Global HEOR Product Leads on plans and timelines for the relevant deliverables. Lead, handle, and mentor a team of Global HEOR Value Writers, fostering a high-performance culture. Lead all aspects of development, review, and quality control of value writing deliverables including GVDs, AMCP dossiers, early HTA briefing materials, reports and scientific publications across multiple pipeline and inline products. Align with Head HTA Strategy & Project Management to ensure deliverables follow product strategy and deliverable timelines. Align with the relevant Amgen processes. Serve as an expert on payer- and HTA-relevant writing materials. Collaborate with Head HTA Strategy & Project management to implement process improvements to speed up delivery of payer- and HTA-relevant materials. Contribute to hiring, training, and performance evaluations within the team. Ensure compliance with all regulatory and quality policies and standards. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The HEOR Value Writing Leader we seek should possess these qualifications. Basic Qualifications & Experience: Doctorate degree in health economics, public health, pharmacy, life sciences, biostatistics or a related field and 2 years of experience in HEOR, Medical or Regulatory writing in the pharmaceutical, biotech, or consulting setting OR, Master’s degree in health economics, public health, pharmacy, life sciences, biostatistics or a related field and 8 to 10 years of experience in HEOR, Medical or Regulatory writing in the pharmaceutical, biotech, or consulting setting OR, Bachelor’s degree in health economics, public health, pharmacy, life sciences, biostatistics or a related field and 10 to 14 years of experience in HEOR, Medical or Regulatory writing in the pharmaceutical, biotech, or consulting setting OR, Diploma in health economics, public health, pharmacy, life sciences, biostatistics or a related field and 14 to 18 years of experience in HEOR, Medical or Regulatory writing in the pharmaceutical, biotech, or consulting setting Proven experience in leading the development of GVDs, AMCP dossiers, and other HTA-related documents. 3+ years of experience in team management capacity. Skills & Competencies: Strong leadership and team management abilities. Excellent English oral and written communication, with ability to tailor content to different key partners. Advanced understanding of clinical, economic, and real-world data and their application in market access. Expertise in global HTA processes, payer evidence requirements, and value demonstration standard methodologies. Knowledge of Good Publication Practice and publication submission process Proficiency in Microsoft Office and reference management tools (e.g., EndNote). Innovative use of artificial intelligence to boost efficiency. Organizational Behaviors: Proactive, collaborative, and solutions-focused leadership style. Strong project management and decision-making capabilities in a dynamic, distributed team environment. Comfortable working in a distributed team across time zones and cultures. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Roles and Responsibilities: Provides Qualifications and Agreements by: Maintaining current, up-to-date curriculum vitae. Maintaining current licensure to practice. Demonstrating the proper education, training and experience to conduct the clinical investigation. Assuming responsibility for the conduct of the clinical investigation. Ensures Protocol Compliance by: Possessing a thorough understanding of the requirements of each protocol. Determining that inclusion / exclusion criteria are applicable to the study population. Ensuring recruitment goals are reasonable and attainable. Reviewing the inclusion / exclusion criteria, schedule of visits, end point criteria and investigational article use with the research team. Manages the Medical Care of Subjects by: Assessing subject compliance with the test product and follow-up visit. Assessing subjects response to therapy. Evaluation of adverse experiences. 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(es). Protects the Rights and Welfare of Subjects by: Ensuring that the informed consent form contains all the elements required. Obtaining a signed and dated informed consent from the subject or subjects legal representative prior to initiation of any study-related procedures. Informing the subject or legal representative about all aspects of the clinical trial. Ensures Documentation of Study-Related Procedures, Processes and Events by: Conduction of physician examination as per the protocol and applicable procedures for volunteers. Documenting deviations from the approved protocol. Documenting that informed consent has been obtained from the subject or legal representative. Documenting adverse event(s). Complying with written procedures to document changes to data and / or case report forms. Maintaining trial documents as required by the regulations and sponsor for the appropriate timeframe and under secure conditions. Maintains Professional and Technical Knowledge by: Attending education workshops. Reviewing professional publications. Participating in professional societies. Other responsibilities as assigned by the DGM-Clinical Operations / Principal investigator from time to time. Desired Candidate Profile can send to email: hr@qpsbioserve.com Note: Opening for 2 Male physician

Roles and Responsibilities Responsible for screening volunteers for clinical study and to decide the eligibility of a subject based on detailed history, physical examination, radiological and electrocardiograph and laboratory parameters. Monitoring, Reporting and Management of Adverse Events/ Serious Adverse Events occurring during clinical study Determination of Volunteer eligibility for Clinical Study as per Inclusion/exclusion criteria of protocol. Maintenance of Emergency Drugs List and ICU set-up. Maintain records of screening procedures as per GCP and other applicable regulatory requirements. Co-ordinate with respective CI/PI/Head in all study related activities. Perform any other activities as and when assigned by the management Desired Candidate Profile Qualification: MBBS with Medical Council registration Job Location: Mangalore - Karnataka (Office based)

Hi, We are hiring for the leading ITES Company for EDC (Veeva & Inform Programmer) Role. JOB DESCRIPTION: Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models • Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 181 b) For Position in Pune Search : Job Code # 182 C) For Position in Bangalore Search : Job Code # 183

We are Hiring For Leading ITES Company for the position of PV Aggregate Reporting Role Job Descriptions To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics and APIs, comprising Solid Dosage Formulations and Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research and Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it's a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R and D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL's full-fledged Regulatory Affairs and IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization.

Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. • Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Reviewer Mumbai (Job Code # 47) b) For Position in Pune Search : Medical Reviewer Pune (Job Code # 48) c) For Position in Bangalore Search : Medical Reviewer Bangalore (Job Code # 51)

Principal IS Architect – Clinical Computation Platform What you will do Amgen’s Clinical Computation Platform Product Team manages a core set of clinical computation solutions that support global clinical development. This team is responsible for building and maintaining systems for clinical data storage, data auditing and security management, analysis and reporting capabilities. These capabilities are pivotal in Amgen’s goal to serve patients. The Principal IS Architect will define the architecture vision, create roadmaps and support the design and implementation of advanced computational platforms to support clinical development, ensuring that IT strategies align with business goals. The Principal IS Architect will work closely with partners across departments, including CfDA, GDO, CfOR, CfTI, CPMS and IT teams, to design and implement scalable, reliable, and hard-working solutions. Develop and maintain the enterprise architecture vision and strategy, ensuring alignment with business objectives Create and maintain architectural roadmaps that guide the evolution of IT systems and capabilities Establish and enforce architectural standards, policies, and governance frameworks Evaluate emerging technologies and assess their potential impact on the enterprise/domain/solution architecture Identify and mitigate architectural risks, ensuring that IT systems are scalable, secure, and resilient Maintain comprehensive documentation of the architecture, including principles, standards, and models Drive continuous improvement in the architecture by finding opportunities for innovation and efficiency Work with partners to gather and analyze requirements, ensuring that solutions meet both business and technical needs Evaluate and recommend technologies and tools that best fit the solution requirements Ensure seamless integration between systems and platforms, both within the organization and with external partners Design systems that can scale to meet growing business needs and performance demands Develop and maintain logical, physical, and conceptual data models to support business needs Establish and enforce data standards, governance policies, and best practices Design and manage metadata structures to enhance information retrieval and usability What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 8 to 10 years of experience in Computer Science, IT or related field OR Bachelor’s degree with 10 to 14 years of experience Computer Science, IT or related field OR Diploma with 14 to 18 years of experience Computer Science, IT or related field Proficiency in designing scalable, secure, and cost-effective solutions. Expertise in cloud platforms (AWS, Azure, GCP), data lakes, and data warehouses. Experience in evaluating and selecting technology vendors. Ability to create and demonstrate proof of concept solutions to validate technical feasibility. Strong knowledge of Clinical Research and Development Domain Experience working in agile methodology, including Product Teams and Product Development models Preferred Qualifications: Strong solution design and problem-solving skills Experience in developing differentiated and deliverable solutions Ability to analyze client requirements and translate them into solutions Experience with machine learning and artificial intelligence applications in clinical research. Strong programming skills in languages such as Python, R, or Java. Experience of DevOps, Continuous Integration, and Continuous Delivery methodology Soft Skills: Excellent critical-thinking and problem-solving skills Good communication and collaboration skills Demonstrated awareness of how to function in a team setting Demonstrated awareness of presentation skills Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: The Database and Edit Check UAT Tester role is responsible for performing database UAT testing, maintaining database testing documentation, developing edit check test specifications, and conducting UAT for edit checks. This role requires close attention to detail and collaboration with other groups to ensure the accuracy and efficiency of our data management databases and edit checks. Roles & Responsibilities: Perform database testing to ensure the integrity and accuracy of data. Maintain comprehensive database testing documentation. Develop detailed edit check test specifications. Conduct UAT for edit checks to ensure they meet the required standards. Communicate and call out day-to-day issues and risks regarding the area of work. Assist with preparation for inspections and provide responses to questions and findings from regulatory authorities and other audits. Participate in data management and cross-functional working groups, including global network representation. Promote and advocate for data management standard methodologies internally and externally. Basic Qualifications & Experience: Master’s degree and 3 to 4 years of life science, computer science, business administration or related discipline or equivalent experience OR Bachelor’s degree and 5 to 6 years of [life science, computer science, business administration or related discipline or equivalent experience OR Diploma and 9 to 10 years of [Job Code’s Discipline and/or Sub-Discipline] experience General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or clinical research organization (CRO) company) Preferred Qualifications Must-Have Skills: Proficiency in database testing and edit check UAT Familiarity with testing and validation plans Proficient in testing documentation standard methodologies Knowledge of Good Clinical Practice Understanding of clinical data management processes Good-to-Have Skills: Familiarity with electronic data capture (EDC) systems and data management plans (DMP). Familiarity in inspection readiness Familiarity of database audit trails Familiarity of Trial Master Files Soft Skills: Excellent communication and collaboration skills. Detail-oriented with strong analytical and problem-solving abilities. Ability to work independently and as part of a team. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let’s do this. Let’s change the world. In this vital role you will responsible for managing and maintaining laboratory reference ranges in the Electronic Data Capture (EDC) system. This role involves providing subject matter expert advice on laboratory data, reviewing local and central laboratory reference range documents, creating lab IDs, and entering the ranges and units for each analyst into the EDC system. This individual also identifies and helps resolve discrepancies in local laboratory reference ranges. Roles & Responsibilities: Approve new lab parameters, new units, and textbook ranges. Provide subject matter expert advice on laboratory data. Review local and central laboratory reference range documents. Create lab IDs and enter the ranges and units for each analyst into the EDC system. Identify and help resolve discrepancies in local laboratory reference ranges. Communicate and call out day-to-day issues and risks regarding the area of work. Participate in DM and cross-functional working groups. Promote and advocate for data management best practices internally and externally. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications. Basic Qualifications: Master’s degree and 1 to 3 years of life science, computer science, business administration or related discipline or equivalent experience OR Bachelor’s degree and 3 to 5 years of life science, computer science, business administration or related discipline or equivalent experience OR Diploma and 7 to 9 years of [life science, computer science, business administration or related discipline or equivalent experience. 2-4 years of related experience in clinical data management or laboratory coordination. Must-Have Skills: Strong understanding of laboratory data and clinical reference ranges. Knowledge of Good Clinical Practice Understanding of clinical data management processes Understanding of International laboratory unit standards such as the International System of Units (SI) Understanding of concept of conversion factors and comparable results Good-to-Have Skills: Familiarity with electronic data capture (EDC) systems and data management plans (DMP). Understanding of Electronic Health Record (EMR) Systems Understanding of Laboratory Certification Understanding of Laboratory Equipment Calibration Soft Skills: Excellent communication and collaboration skills. Detail-oriented with strong analytical and problem-solving abilities. Ability to work independently and as part of a team. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

We are currently hiring for DSA I role with a minimum of 3 to 5 years Of experience in Pharmacovigilance Perform triage & intake of ICSR received daily in ARGUS databases. Ensure data entry of ICSR in ARGUS Knowledge In Aggregate Reporting is Must Required Candidate profile Require 3 to 5 years of pharmacovigilance case processing experience. Responsible for coding events using MEDDRA Any Life Sciences(B pharm/M Pharm/ Pharm D, Life Sciences, Nursing, BDS, BPT)

We are currently hiring for DSA I role with a minimum of 1 year experience in Pharmacovigilance Perform triage & intake of ICSR received daily in ARGUS databases. Ensure data entry of ICSR in ARGUS Required Candidate profile A minimum of 1 year pharmacovigilance case processing experience. Responsible for coding events using MEDDRA Any Life Sciences(B pharm/M Pharm/ Pharm D, Life Sciences, Nursing, BDS, BPT) are Eligible