124 Veeva Vault Jobs - Page 5

Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Hi, We are hiring for Leading ITES Company for Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 Role & Responsibilities: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Job Location-- Noida/Gurgaon/Hyderabad/Kolkata/Bangalore/Mumbai/Pune/Chennai Develop tailored Veeva CRM solutions that address specific business needs and align with organizational goals. • Work closely with business analysts, stakeholders, and other technical teams to gather requirements and translate them into technical specifications. • Oversee the implementation and configuration of Veeva CRM, ensuring a seamless deployment in line with industry best practices. • Provide expert guidance on data management, system integrations, and any necessary system upgrades. • Create and maintain comprehensive documentation of system architecture, processes, and configurations for future reference. • Support regulatory compliance initiatives, ensuring adherence to data governance policies. • Co-ordinate with business and technical teams for Veeva CRM and integration • Experience in working with the Life Science industry and understanding of Veeva CRM applications • POC from the project team for customer • Ability to address salesforce platform specific questions and work with the integration team to support the build integrations, Veeva (CRM) integrations, and API client integrations. • To be able to work on current problems while thinking of future solutions. • Ability to drive creative and efficient use of technology and thrive in a team environment. • Highly skilled technologist who can strategize the full lifecycle of product production from conception through to release. • You have strong communication skills and can translate technical concepts to non-technical terms and partners. • Strong knowledge of Veeva CRM and Veeva Vault Promomats. Qualifications we seek in you! Minimum Qualifications / Skills Extensive experience in CRM architecture, implementation, and integrations, with a focus on Veeva CRM. • Strong knowledge of Veeva CRM architecture and related integrations. • Solid understanding of data management, compliance, and governance standards in the pharmaceutical industry. • Excellent communication skills to interact effectively with business stakeholders, technical teams, and other organizational levels. Preferred Qualifications/ Skills BTech/MCA/BE/BSC/Any Graduation Veeva CRM Certified Veeva Vault Certified

Roles & Responsibilities: Collaborate with System Architects and Product Owners to manage business analysis activities for Veeva - Site Collaboration and Veeva Vault Study Training systems, ensuring alignment with engineering and product goals. Capture the voice of the customer to define business processes and product needs. Collaborate with Veeva - Site Collaboration and Veeva Vault Study Training business partners, Amgen Engineering teams and Veeva consultants to prioritize release scopes and refine the Product backlog . Support the implementation and integrations of Veeva - Site Collaboration and Veeva Vault Study Training systems with other Amgen systems. Ensure non-functional requirements are included and prioritized in the Product and Release Backlogs. Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team. Clearly express features in User Stories/requirements so all team members and collaborators understand how they fit into the product backlog . Ensure Acceptance Criteria and Definition of Done are well-defined. Stay focused on software development to ensure it meets requirements, providing proactive feedback to customers. Develop and implement effective product demonstrations for internal and external partners . Help develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements. Identify and manage risks associated with the systems, requirement validation, and user acceptance. Develop & maintain documentations of configurations, processes, changes, communication plans and training plans for end users. Ensure operational excellence, cybersecurity, and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement . 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 4 - 6 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR Bachelor's degree with 6 - 8 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR Diploma with 10 - 12 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies Preferred Qualifications: Experience with Agile software development methodologies (Scrum). Good communication skills and the ability to collaborate with senior leadership with confidence and clarity. Strong knowledge of clinical trial processes especially Site Collaboration and Study Training process. Familiarity with regulatory requirements for Clinical Trials (e.g. 21 CFR Part11, ICH ). Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA. Good-to-Have Skills: Familiarity with Veeva Clinical Platform, especially Veeva - Site Collaboration and Veeva Vault Study Training systems . Experience in managing product features for PI planning and developing product roadmaps and user journeys. Experience maintaining SaaS (software as a system) solutions and COTS (Commercial off the shelf) solutions. Technical thought leadership. Able to communicate technical or complex subject matters in business terms. Jira Align experience. Experience with AWS Services (like EC2, S3), Salesforce, Jira, and API gateway, etc. SAFe for Teams certification (preferred). Certifications in Veeva products (Preferred). Certified Business Analysis Professional (Preferred). Soft Skills: Able to work under minimal supervision . Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work. Excellent analytical and gap/fit assessment skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams . High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills.

Roles & Responsibilities: Design, Build and maintain integrations between Veeva Vault - Clinical Operations and other applications in the Clinical Operations ecosystem. Analyze and understand the functional and technical requirements of applications, solutions and systems and translate them into software architecture and design specifications Develop and implement unit tests, integration tests, and other testing strategies to ensure the quality of the software Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as a customer concern point and facilitating communication when service commitments are not met Collaborate with geographically dispersed teams, including those in the US and other international locations. Oversee the software development lifecycle using Scaled Agile Framework (SAFe) Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Contribute and define business outcomes + requirements, technology solutions, and services. Participate in collaborator and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery. Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services. Facilitate standard process sharing, ensuring ongoing alignment with the Technology & Digital strategy. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate Degree OR Masters degree with 4 - 6 years of experience in Business, Engineering, IT or related field OR Bachelors degree with 6 - 8 years of experience in Business, Engineering, IT or related field OR Diploma with 10 - 12 years of experience in Business, Engineering, IT or related field Preferred Qualifications: Solid experience in implementing and managing application integrations using technologies such as MuleSoft. Experience on Veeva Vault Clinical Operations applications. Experience in people management and leading matrixed teams, and passion for mentorship, culture and fostering the development of talent. Experience with version control systems like Git. Good understanding of cloud platforms (e.g., AWS, GCP, Azure) and containerization technologies (e.g., Docker, Kubernetes) Good-to-Have Skills: Extensive experience in the software development lifecycle. Experience with software DevOps CI/CD tools, such Git, Jenkins, Linux, and Shell Script. Experience using and adoption of Scaled Agile Framework (SAFe). Strong analytic/critical-thinking and decision-making abilities. Broad working knowledge of key IS domains and layers. ITIL (preferred) Scaled Agile Framework (SAFe) for Teams Veeva Vault platform (preferred) Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Exceptional collaboration and communication skills. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams

What you will do Let's do this. Let's change the world. In this vital role you will responsible for leading the testing activities for software applications and solutions that meet business needs and ensuring the availability of critical systems and applications. This role is for a lead tester and validation expert with functional and system knowledge for Clinical Data Management, Interactive Response Technology (IRT) solutions. The role involves working closely with product managers, designers, and other engineers to test high-quality, scalable software solutions. Roles & Responsibilities: Participate in requirement discussions related to the RBM / RBQM system(s) within Clinical Data Management and Interactive Response Technology (CDMIRT) product team, in order to create test scripts. Build test scripts per implementation project plan by working with various members of the product team and business partners. Conduct informal and formal testing, consolidate all the findings and coordinate with developer(s) and business partners to resolve all the issues. Perform regression testing to verify the changes do not negatively impact existing system functionality. Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements. Identify and resolve technical challenges/bugs effectively. Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time. Support the creating and implementation of automated testing frameworks to improve efficiency and consistency. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate Degree OR Master's degree with 4 - 6 years of experience in Computer Science, IT or related field OR Bachelor's degree with 6 - 8 years of experience in Computer Science, IT or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT or related field. Preferred Qualifications: Must-Have Skills: Knowledge of clinical trial processes specifically software validation processes. Experience with testing methodologies and automation practices. Experience with testing tools such as HP Application Lifecycle Management (ALM) and Veeva vault validation management. Experience in conducting testing activities in GxP systems. Good Problem-solving skills - Identifying and fixing bugs, adapting to changes. Good communication skills - Explaining design decisions, collaborating with teams. Experienced in Agile methodology. Good-to-Have Skills: Experience in Risk-based Approach to Change Management of Validated GxP Systems. Solid understanding of SQL scripting. Experience in RBM/RBQM systems. Experience with cloud-based technologies. Professional Certifications (please mention if the certification is preferred or mandatory for the role): SAFE for Teams certification (Preferred) Soft Skills: Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills

The Regulatory Data & Systems Senior Associate will be responsible for interpreting and executing business requirements, based on a combination of industry best practice and Amgen regulatory processes. This role involves optimizing complex data systems supporting the health authority submission process, while ensuring compliance with regulatory regulations and guidance. The ideal candidate will have a strong background in system analysis and data science/AI in a regulated industry. Roles & Responsibilities: Data Administration/AI: Optimize and maintain the organization's complex data models, ensuring they are integrated, efficient, and compliant with regulatory requirements. Regulatory Business Analysis: Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices. Project Coordination: Assist in planning, tracking, and executing departmental projects and initiatives. Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates. Required Knowledge and Skills: Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors. 5+ years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & agile systems development methodologies. Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner. Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction. Familiarity with GxP requirements and systems validation. Life Sciences, Biotech or pharmaceutical industry experience. Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault Familiarity with global regulatory processes and standards. Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment. Basic Education and Experience: Bachelors degree and 2 years of directly related experience Associates degree and 6 years of directly related experience High school diploma GED and 8 years of directly related experience Preferred Education and Experience: Practical experience with regulatory data standards, such as IDMP 5+ years experience in data management, machine learning, or related fields.

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 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55

Roles and Responsibilities Design, develop, and execute test plans for Salesforce Automation Testing/MS Dynamics CRM applications to ensure high-quality delivery. Collaborate with cross-functional teams to identify defects and implement fixes in a timely manner. Develop automated tests using Selenium Automation framework/MSCRM /Selenium Automation to improve testing efficiency. Participate in Agile development methodologies such as Scrum to deliver projects on time. Desired Candidate Profile 3-9years of experience in Salesforce Automation Testing/MS Dynamics CRM Proficiency in developing automated tests using Selenium Automation framework. Experience working on Veeva CRM/Vault implementation projects. Skill:Any One Required 1.Salesforce Automation Testing or 2.MSDynamics/MS CRM OR 3.Selenium Automation Testing -Java Coding

Develop and execute manual test scripts, create validation artifacts (IQ/OQ/PQ, UAT), perform dry runs and defect retests, trace requirements, collaborate with cross-functional teams, and support agile-based QA across Veeva Vault applications. Required Candidate profile Manual QA professional with 2+ years in Veeva Vault testing, experience in validation documentation, agile SDLC, pharma domain exposure. Preferably familiar with SFDC/Veeva CRM and basic automation

Team Leadership & Oversight Support and mentor a team of Clinical Data Specialists, promoting consistency, quality, and productivity. Collaborate on training plans, performance goals, and team development. Provide day-to-day guidance and technical support related to data issues. Help manage team capacity, workload distribution, and scheduling across studies. Foster effective collaboration with cross-functional teams. Data Management & Quality Assurance Accurate data maintenance, quality control, and discrepancy resolution in CTMS and EDC systems (e.g., RAVE, Veeva Vault, Clinical One, Inform). Review source documents for adherence to ALCOA-C principles and regulatory guidelines (GCP, HIPAA, FDA). Identify and resolve data inconsistencies and protocol deviations. Collaborate with clinical operations to ensure accuracy and completeness of source documentation. Support audit readiness through rigorous documentation practices and participation in quality reviews. Assist in creating source documents from protocols, CRFs, and lab manuals. Drive timely completion of data cleaning and database lock activities. Track and report key metrics for data quality and operational efficiency. Process Development & Compliance Develop SOPs, training guides, and implement process improvements. Identify inefficiencies and propose solutions to enhance workflow and team productivity. Participate in audits and collaborate on regulatory responses. Promote adherence to industry and internal standards. Cross-Functional Collaboration Serve as the point of contact for clinical data inquiries across assigned studies. Coordinate timelines and deliverables with project managers, monitors, and external stakeholders. Support all phases of the clinical study lifecycle from initiation to close-out. Qualifications and Experience Bachelor's degree in life sciences, health sciences, nursing, or a related field. Minimum 12 years of relevant experience, with at least 7 years in a Clinical Research Coordinator or Clinical Data Management role. Prior Managerial experience is a plus; must exhibit ability and willingness to take on supervisory responsibilities. Strong knowledge of CTMS (e.g., CRIO) and EDC systems such as RAVE, Veeva Vault, Clinical One, and Inform. Solid understanding of GCP, HIPAA, ALCOA-C, and clinical trial protocol standards. Must demonstrate ability to read, interpret, and operationalize clinical protocols. Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). Ability to work independently while building processes and guiding others. Willingness to align with US operating hours.

Role: EDC Programmer (Veeva Vault) Loc: Mumbai, Pune, Bangalore, Indore, Ahmedabad | Exp: Int’l BPO | No TCS rehires Skills: Veeva Vault EDC, CQL, CDB, JSON, C#, SAS/R/Python, Medidata Rave, Oracle Inform, CTMS, Data Warehouses Required Candidate profile Responsibilities: Design & program eCRFs in Veeva, configure SDV/SDR, edit checks Develop/test study rules, manage UAT, eTMF docs Post-go-live changes, impact analysis, QC

Role & responsibilities Role : Third Party Data Acquisition Study Analyst * Collaborate closely with the Third Party Data Acquisition Study Analyst to facilitate the setup and acquisition of external clinical data at the study level during study startup, conduct, and closeout phases. * Ensure data accuracy, completeness, and consistency through effective cleaning, validation, and transformation processes. * Monitor data feeds regularly to uphold data quality and accuracy. * Support the setup of infrastructure enabling external data integration into client's clinical data pipelines. * Provide guidance and coordination to vendors on data acquisition systems, including GlobalScape, Veeva FTP, Veeva training, and IP whitelisting. * Review incoming data from multiple sources to confirm compliance with Data Transfer Agreements (DTA) regarding format, file extensions, and field requirements. Validate all third-party data generated during clinical trials for integration into Clients clinical data ecosystem. * Assist the Third Party Data Acquisition Study Analyst in conducting periodic Trial Master File (TMF) reviews per the study TMF plan. * Adhere to procedural documents and participate in their review and updates to ensure alignment with industry standards, regulatory requirements, and best practices. * Coordinate with and review deliverables from external partners (e.g., labs, eCOA providers, technology vendors) performing services for Client. * Appropriately escalate issues to the Third Party Data Acquisition Study Lead. * Routinely monitor proprietary applications for scanned mail and distribute documents to relevant teams.Perform regular quality checks to ensure optimal system performance and data integrity. Preferred candidate profile

Veeva Platform Engineer - Payments Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Purpose and Scope: As a Platform Engineer of a team of individuals in a specific area of digital expertise, you will be a crucial player in driving our digital initiatives forward in our agile organization. Our agile operating model consists of two components Digital Capability and Digital Execution. Digital Execution are about aligning multiple missions around business goals and facilitating collaboration on a larger scale. Digital Capability, on the other hand, focus on the growth and development of individuals within a specific expertise area. This dual structure enables us to scale agile practices efficiently while maintaining a focus on both product development and individual skill enhancement. An Enterprise Business Platforms Engineer focuses on the development, deployment, and integration of software platforms that support our business processes and operations. This role involves a blend of technical expertise, business acumen, and a deep understanding of Veeva Clinical Platform. The goal is to ensure these platforms are optimized to support business goals, enhance efficiency, and drive growth. You will be at the forefront of implementing innovative solutions and will have the opportunity to work on cutting-edge technologies in your field. Essential Job Responsibilities: Platform Development and Configuration: Design, develop, and configure business platforms to meet the specific needs of our organization. This could involve programming, configuring settings, and integrating various software solutions. System Integration: Ensure seamless integration between different business platforms and systems (e.g., integrating CRM and ERP systems) to enhance data flow and business processes. Performance Monitoring and Optimization: Regularly monitor the performance of business platforms, identify bottlenecks, and implement optimizations to improve efficiency and user experience. User Support and Training: Provide technical support to platform users, resolve issues, and conduct training sessions to ensure users can effectively utilize the platforms. Initiative Execution: Actively participate in and contribute to various initiatives, applying your specialized skills to achieve the objectives and expected Value. Contribute to the ongoing realization of Value from these enterprise platforms through continuous integration and deployment. Collaboration: Work collaboratively with team members within the subdivision and across other digital and business units. Continuous Learning: Engage in continuous learning and professional development to stay abreast of the latest trends and technologies in a specific area of expertise. Innovation: Contribute innovative ideas and approaches to enhance project outcomes and digital capabilities. Reporting: Regularly report on the progress of the various Value Teams and outcomes to your Capability Lead and team members. Problem-Solving: Employ analytical and problem-solving skills to overcome project challenges and deliver effective solutions. Quality Assurance: Ensure the highest quality and consistency in the work delivered. Requirements Qualifications: Required Bachelors degree in relevant field, e.g., Computer Science, Data Science Minimum of 3-5 years of demonstrated relevant experience Demonstrated experience in developing and configuring in the Clinical Operations space using Veeva Vault Payments Business Process Understanding: Knowledge of Clinical operations business processes and how Vault Clinical supports these processes Strong analytical and problem-solving skills Ability to work effectively in a team environment Excellent communication skills, both written and verbal Agile and adaptable to changing environments and project scopes Present technical solutions based on the business requirement of the Clinical Veeva system. Able to support technical upgrade on quarterly basis by conducting technical impact assessment, addressing any technical issues, support the environment management, support testing, and document changes per the SLC process Manage user account, create roles, and support quarterly user access review request. Support system deliverables and provide technical feedback during internal and external Veeva Clinical system audit Work closely with the internal privacy and security team to assess Personal Information requests and act according per the privacy laws Maintain and report any issues and communicate effectively to all stakeholders during project/enhancement phase, service disruptions, and during the technical upgrade Preferred Veeva Admin Certification 1-3 years demonstrated experience with Veeva Vault Clinical Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery Technical Proficiency: Strong coding skills in relevant tools and technologies, e.g., Java, C++, Python, R, SQL is highly beneficial

Job Title: Veeva Vault Clinical Engineer Experience: 5+ Years Location: Bengaluru, India (Hybrid 2 days/week in office) Note: Immediate to 30-day joiners preferred. About the Role: We are looking for an experienced Veeva Vault Clinical Engineer with a strong background in CTMS, eTMF, and CDMS (EDC) . The ideal candidate will have hands-on experience in Veeva Vault configuration, integration, and support activities. Youll work closely with cross-functional teams to support and enhance clinical trial systems, contributing to the smooth execution of clinical operations. Key Responsibilities: Configure and support Veeva Vault Clinical applications including CTMS , eTMF , and CDMS (EDC) . Perform system integrations, connections, and enhancements within the Veeva Vault ecosystem. Required Skills: Minimum 5 years of experience working with Veeva Vault Clinical Suite , particularly CTMS , eTMF , and CDMS . Strong hands-on experience in EDC build , configuration , integrations , and technical support . Familiarity with clinical trial processes and how they align with clinical systems is a strong advantage. Proven ability to demonstrate both technical and functional expertise in Veeva Vault systems. Excellent problem-solving, communication, and collaboration skills. Location: Bangalore, India – Hybrid model (2 days/week from office) Note: Immediate to 30-day joiners preferred.

The ideal candidate will have experience in graphic design with a focus on regulated environments and a strong understanding of pharma-specific packaging components such as labels, cartons, leaflets, and blister packs.

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)

Key Responsibilities: Participates in the estimation of activities, owns technical implementation of the SaaS application, and responsible for the design, configuration and integration for new and modified features for CTMS/eTMF and other Veeva Vaults. This role will have a keen focus to detail through ensuring Veeva applications is deployed using the framework of the Veeva Vault configuration standards and best practices. Works closely with business to understand the business requirements. Thinks critically to help them design the solution they actually need; not just the solution they think they need. Participates in the requirements workshops, design, prototype, configure and document Veeva solutions. Implements Veeva suite of application to meet the business, functional, security and integration requirements either via configuration or custom development using Veeva Vault SDK. Participates in the testing and validation activities by helping in the creation and review of test scenarios, data staging, test executions and validation documents. Works with the Veeva support teams to provide technical solutions to production issues/integration issues. Experience: Experience working with or for Life Sciences companies; including, Pharmaceutical, Biotechnology, Healthcare, or Medical Device organizations with knowledge of drug development processes and regulatory submissions Solid experience in configuration in Veeva Vault and a strong learning attitude towards other vaults in Veeva. Exposure in Veeva Vault Data Model - Understanding of Products, eTMF, Clinical Studies, Sites. System implementation experience as developer for Veeva application. Desirable experience working with Veeva Vault SDK to deliver custom solutions by extending the application capabilities. Fair understanding of Veeva Vault data model, data loader and migration tools and technologies Understand and implement Veeva integrations (Vault to Vault / Vault to other systems or middleware like MuleSoft) Understanding of health care regulations, international regulations, and privacy controls Basic Qualifications : Bachelors Degree (or equivalent work experience) 3+ years of experience in Veeva application configuration/development Strong teamwork, self-management, problem-solving abilities Excellent oral and written communication skills Trained and Certified in Veeva Vault

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)

Veeva Vault Exp: 5 to 8 Years Location: Bangalore Should have experience in Veeva QMS Veeva QDocs and RIMS Good experience in workflows and comprehensive audit trails for quality management of change controls CAPA deviations as well as supplier quality management and internal audit Understand complete workflow of authoring documents approval workflows and integrated repository to SAP SuccessFactors validated Support requirements Manage all Service Requests and Incidents troubleshooting the application and product related errors and issues Debugging and troubleshooting Interface related errors and issues Boomi and Java Providing application and business process related SME assistance on design or functionality Administration development and services that relate to design build testing or maintenance activities Provide enhancements for business as required Assess the impact for periodic upgrades and support on implementing all upgraded features All vault modules get upgraded with new releases 3 times a year New functionality assessment for Emergent based on release or based on user requirement User Administration supporting roles and access management requests

Job Title / Primary Skill : Associate TMF Lead Years of Experience : 6-10 Years Job Location : Bangalore/Thane Must Have Skills : eTMF, Stakeholder Management, Lead experience Good to Have Skills : Veeva Vault Job Description Serve as the liaison between Records Management and user departments regarding Trial Master files • Apply Records Management expertise to provide project related assistance across complex and multiple project(s), sites, and project teams • Ensure project deadlines, commitments, and goals are met by monitoring projects daily outputs • Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, meets quality and timeline metrics • Serve as primary contact for internal/external clients • Coordinate the retrieval of records requested by users and prepare closed studies for transfer to final destination within the agreed timelines • May assist management with the implementation of plans, cost proposals, and resource projections for records management projects • Train team members on records management tasks, policies, and procedures • Collect data and assist in the preparation of statistical reports for management of record center operations, as appropriate or as requested • May lead teams functionally, where assigned, including awareness of scope of work, budget, and resources • May maintain accurate trackers and systems to control records and box inventory • May coordinate transfer, recall, and disposition of records to commercial records storage centers • May oversee disposal of obsolete records and ensure efficient maintenance of records storage space, supplies, and equipment • Maintain records center security to protect record integrity by ensuring compliance to SOPs Professional Attributes Excellent organizational, communication, leadership and computer skills. •Ability to exercise excellent attention to detail. •Ability to act independently and with initiative required to resolving problems. •Ability to establish and maintain effective working relationships with coworkers, managers and clients. •Excellent organizational, communication, leadership, and computer skills. •Ability to exercise excellent attention to detail. •Ability to act independently and with initiative required to resolving problems. •Ability to establish and maintain effective working relationships with coworkers, managers and clients. Qualifications • Bachelor's degree in health care or other scientific discipline or equivalent combination of education, training and experience.

Veeva RIM L1 & L2 Support Tasks General User Management Provision User access requests & update requests including inactivation and profile updates Login/SSO issues Missing notifications Troubleshooting record level access control Periodic User Dormancy Bulk data creation/update/deletion User Education Related Queries Integration Data discrepancy(Inbound/outbound sync issues, Integration job failures) Monitor scheduled jobs Object records state change request Constraints/Control Vocabulary updates Content Plan template Creation/Updates/Deletion Submission Import activities Upload submission documents using loader Content plan generation issues Troubleshooting Permission issues related to document/object records Object records state change request Configuration Picklist/value mapping updates Lifecycle/workflow updates Field visibility/layout updates DataType/Field Dependency Lifecycle Entry Criteria/Action Reporting Basic report generation Advanced report troubleshooting Audit trail extraction Flash Report config Dashboard related activities Veeva General Releases 3xs Support R1, R2, R3 releases (Testing + Documentation) Other Collaborative Authoring issues + periodic SharePoint storage checks and expansion E-signature issues Provide Troubleshoot instruction to end users on the issues they face on their daily activities Periodic SSL certificate renewals EMA gateway issues Email notifications issues MedDRA updates CV updates Migration related support Troubleshoot user not able to find document/Missing Document Incorrect field values found on the document Document not rendering Preparing and validating the loader sheets

Position: Data Quality System Testing Consultant Experience: 10+ Years Mode: Remote Time: US EST Hours Objective / Purpose: Create and execute detailed test plans and UAT scripts in Excel and /or ALM testing system based on business requirements and technical specifications to verify study/library functionality in Veeva CDMS and/or Rave EDC system and adherence to standards. Drive study database user acceptance testing activities and ensure the quality of the study build in the EDC system. Ensure accurate delivery of study build with quality deliverables per specification. Participate in the development, maintenance and training rendered on activities around study build and best practices used by business. Lead UAT activities for studies and libraries in EDC system, including inbound integrations with an Agile Approach according to applicable SOPs (standard operating procedures) and processes. Develop UAT documentation such as Test Plans, UAT Scripts, UAT Summary Report and etc. Create and execute standardized test scripts for EDC components, inbound integrations, and data listings. Record and document test results and compare to expected results. Detect software and specifications failures, so that defects may be discovered and corrected. Communicate actively with management and clinical teams about testing progress and challenges. Collaborate with cross-functional teams and vendors to ensure integration accuracy. Demonstrate strong understanding of electronic data capture and clinical data management systems, clinical databases, data flow, and related infrastructure, with experience in/around EDC systems such as Veeva CDMS and Rave, Veeva CDB, elluminate Data Central, EHR, eCOA, IRT, RTSM, TSDV, DMR and adjacent systems. Accountabilities: Test Plan and Script Execution: Create and execute detailed test plans and User Acceptance Testing (UAT) scripts, ensuring alignment with business requirements and technical specifications. Validate study/library functionality within EDC systems and confirm adherence to established standards. Testing Strategy Development: Develop and enhance testing strategies for EDC system study/library builds and integrations UAT Documentation Development: Develop comprehensive UAT documentation, including Test Plans, UAT Scripts, and UAT Summary Reports. Standardized Test Script Creation: Develop and execute standardized test scripts for EDC components, inbound integrations, and data listings. Testing Results Analysis: Record and document test results, comparing them to expected outcomes. Identify software and specification failures for timely defect resolution. Communication and Reporting: Actively communicate with management and clinical teams about testing progress, challenges, and outcomes. Support for Special Projects: Assist in special projects and automated testing initiatives, including the identification of tools for manual UAT script automation. Cross-functional Collaboration: Work closely with cross-functional teams and vendors to ensure accuracy and efficiency in system integrations. Expertise in Clinical Data Systems: Demonstrate in-depth knowledge of electronic data capture, clinical data management systems, and related infrastructure. Utilize experience with various EDC systems (e.g., Veeva CDMS, Rave) and related clinical research technologies (e.g., eCOA, IRT, RTSM). Core Elements Related to this Role: Thorough knowledge and understanding of test case development processes, focused on clinical data with a strong knowledge of clinical study design in EDC and an understanding of clinical data management operations. Proven track record in development and management of test documentation including Test Plans, Test Scripts and Test Summary reports and in-depth knowledge of study design through submission. Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge) Comprehensive understanding of the pharmaceutical industry and clinical development. Functional level expertise of testing and validation of clinical systems. Comprehensive understanding of medical concepts, clinical data flow and systems used in the clinical space. Hands-on experience and knowledge of the various components of EDC system and clinical study lifescycle. Good knowledge of clinical systems and tools (e.g. Veeva CDMS, Rave EDC, Veeva CDB, Elluminate) Desirable technical expertise (e.g., Windows NT and UNIX operating systems) and familiarity with common test case management software, familiarity with ALM, UFT, Tosca and Qtest. Expertise in the requirements and technology required to support electronic data capture and electronic submissions. Interaction (The span and nature of ones engagement with others when performing ones job, internal and external relationships) Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills. Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace. Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise. Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner. Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions. Proven track record in identifying and implementing organization-wide initiatives, standards, and processes. Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking) Forward thinking with the ability to recommend, influence and implement organizational change and continuous improvement. Comfortable challenging the status quo and bringing forward innovative solutions. Ability to take risks implementing innovative solutions, accelerating time to market. Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business. Role models respect and inclusion, creating a culture that fosters innovation. Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo. Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations) Ability to work in a global ecosystem (internal and external) with a medium to high degree of complexity. Ability to see and understand broader, enterprise level perspective as well as from collection through submission perspective. Education & Competencies (Technical and Behavioral): BS/BA or MS in a Life Science, Computer Science, IT, Engineering, or related field or analytical area with ~10 years of experience in a CRO/pharmaceutical environment with a proven and consistent record of proactive management and innovation. Experience with EDC and clinical data management systems. Familiarity with clinical research technologies (e.g., eCOA, IRT, RTSM). Experience in software testing and quality assurance. Proficiency in Agile methodologies and adherence to SOPs. Understanding of clinical data management processes and regulations. Strong problem-solving skills and attention to detail. Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus. Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables. Interested Candidate can apply: dsingh15@fcsltd.com