We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Chennai, Tamil Nadu, India
INR 1.5 - 3.0 Lacs P.A.
On-site
Full Time
Facilitate key discussions with various stakeholders as requested by system owner/platform lead and provide SME technical support on system testingof the Core EDC Product,and anydata integrations (in and out)of EDC. Perform impact analysis for any change that happens on the EDCsystem Work with business and perform risk assessment during change implementations/systemupgradesor updates tointegrations Follow andparticipatein validation lifecycle for upgrades, changes, & new integrations Co-develop validation packagesin accordance withstandard operating procedures (SOPs). Provide support of code review and solutioningfor downstream customer requirements, including data extraction methods (SQL, Webservices, APIs) Activelyparticipatein business meetings and bringnew ideasto thetable Responsibleto solveday-to-day incidents, service requests andworktowards incident-reduction and automation. Also, update Service Now (ticket management tool) for all events with respect to the incidents, service requests,changesand problems. Constantly thrive to learn and upskill according to the organization s goals and demands. CreateGxpValidation Test cases inJiraXrayfor system/upgradetesting Perform validationtest executions in Jira Xray,for bothsystem testingand regression testing. Assistin creating or create UAT test cases that cover the essential business scenarios/use casesfor the business. Facilitateprocess requirementsgathering:capturing user stories, requirement analysis, data analysis, programming, database management, and systems integration. Mandatory Skills Extensive experience of usingMedidataRAVE UI(Classic or Rave EDC)to perform the following actions: Study build, edit checks programming, deployment to production andmigration Understanding aboutdifferent rolesand permissions in Rave Understanding of core configuration and clinical views Understanding of what data extraction capabilities there are Hands on Experience of Inbound Rave Web Services (egIVRS or discrepancy inputs) Experience of setting up Rave safety gateway (RSG) and SAE notifications Experience of setting up SAS extracts Experience on setting up Target Source Data Verification (TSDV) Hands on experience of being involved in URL upgrade(s) (Medidata release updates) Knowledge on system validation process / Application Life Cycle Management Must havestrong communicationskills and interpersonalskills Responsible to work on technical tasks to keep the Rave URL(s) andit sintegrations in a maintained state Adhere to AZ core ITIL guidelines and perform tasks as incident, change, problem etc. Working experience in clinicalstandard anddatacollection, clinical data conversion or clinical data programming/testing. Understandingof CDASH, SDTM,ADaMCDISC controlled TerminologyandFDA/ICH guidelines for clinical studydata Effective in stakeholder management, translating technical concepts, and working within team environments. Skilled in project management basics and creating clear technical documentation. Preferred Skills Hands on Experience of custom function,SASprogramming Knowledge on Coder/ Coder+setup&Lab setup Hands on Experience of outbound Rave Web Services (ODM Adapter, Biostats Adapter) Hands on Experience of Rave backend data model,sqlscript writing, stored procedures Hands-on knowledge in agile management tools like Service NOW Hands-on experience in performing system testing including authoring and executing testcases Passion for learning, innovating, and delivering valuable software to people. Any other programming languages/technical skillse.g: Python, JAVA, etc. Knowledge of other Medidata products and/or Cloud EDCtesting(Rave/Inform/Veeva)experience. Educational Requirements Bachelor or master sdegree in computer science or life science related discipline with IT/CRO/Pharma experience with total of8+ years of experience
Chennai, Tamil Nadu, India
INR 3.0 - 7.5 Lacs P.A.
On-site
Full Time
Accountabilities: Develop and maintain ServiceNow reports and dashboards across various modules (ITSM, HRSD, CSM, SecOps, etc). Create and optimize List, Pie, Bar, Heatmaps, Trend Charts, and Pivot Reports for actionable insights. Use Performance/platform Analytics to build KPIs, scorecards, and trend reports. Implement user experience analytics and Self-Service Analytics. Ensure report accuracy, optimization, and compliance with business and security requirements. Automate and schedule reports to ensure timely data delivery for stakeholders. Extract and transform ServiceNow data using REST APIs and database queries. Collaborate with ServiceNow administrators, developers, and business teams to gather and refine reporting requirements. Develop custom scripts and indicators to enhance analytics capabilities. Provide end-user training and documentation for report generation and dashboard usage. Implement standard methodologies for database design, performance tuning, and querying in Snowflake. Develop ETL/ELT processes to ensure seamless data integration from various sources into Snowflake (not limited to Power BI). Create and maintain documentation for data pipelines, data modeling, and data integration processes. Monitor and optimize the performance of Snowflake instances and fix any issues that arise. Collaborate with data architects, data scientists, and business stakeholders to gather/document the requirements and define data strategies. Collaborate with the product owner to review and document access permissions for Snowflake, as we'll as the associated reports and dashboards. Essential Skills/Experience: 3+ years of hands-on experience in ServiceNow Reporting & Dashboards Proficiency in Platform/Performance Analytics and MetricBase Knowledge in SQL query to extract data from Snowflake. Experience with Filters, Data Sources, and Scheduled Reports Solid understanding of ServiceNow Tables, Query Builder, and Data Schema Experience with REST APIs for data extraction and integration Basic JavaScript & Glide APIs experience for custom reporting (preferred) Experience integrating ServiceNow reports with BI tools (Power BI, Tableau, etc) Solid understanding of data warehousing concepts and standard methodologies. Proficient in SQL for data manipulation and querying. Experience with ETL/ELT tools and processes. Familiarity with cloud platforms such as AWS, Azure, or Google Cloud is a plus
Chennai, Tamil Nadu, India
INR 10.0 - 15.0 Lacs P.A.
On-site
Full Time
What you ll do We are seeking a strategic and technically adept Lead AI Implementation Architect to spearhead the integration of AI tools into our SAP S/4HANA landscape. This pivotal role will drive the design, development, and deployment of intelligent solutions that enhance business processes, leveraging SAP Business Technology Platform (BTP) and AI/ML capabilities. You will lead the implementation of AI tools to accelerate the SAP software development lifecycle. The tools implemented will be applicable to all SAP technologies in use at AZ. The role involves both proof of concept work and embedding AI technology in validated systems. AI Solution Design & Integration: Architect and implement AI-driven solutions within the SAP S/4HANA environment, utilizing SAP BTP, SAP AI Core, and SAP AI Foundation to enhance business processes Technical Expertise & Innovation: Stay abreast of emerging AI technologies and methodologies, evaluating their applicability to SAP environments and driving innovation in AI tool integration, (e.g. SAP Joule, GitHub CoPilot) Stakeholder Collaboration: Work closely with development colleagues in ECS SAP and DevOps as well as the wider Axial programme. Promote AI tools and increase awareness and usage outside the development community. Governance & Compliance: Establish and enforce best practices for AI development, ensuring solutions adhere to data governance, security, and ethical standards Performance Monitoring & Optimization: Implement monitoring frameworks to assess the performance of AI solutions, driving continuous improvement and scalability. Essential for the role Educational Background: Bachelor s or master s degree in computer science, Engineering, Data Science, or a related field Professional Experience : Minimum of 10 years in SAP development and implementation, with at least 3 years focused on S/4 HANA, AI/ML integration within SAP ecosystems. Technical Proficiency: Hands-on experience with SAP BTP, SAP AI Core, SAP AI Foundation, and AI/ML frameworks such as TensorFlow, PyTorch, and scikit-learn Programming Skills: Proficiency in programming languages including Python, JavaScript (UI5/React), and ABAP. Communication Skills: Exceptional verbal and written communication skills, with the ability to convey complex technical concepts to non-technical stakeholders. Desirable for the role Certifications: SAP S/4HANA certification or equivalent. Industry Experience: Experience in sectors such as manufacturing, logistics, or pharmaceuticals, where SAP S/4HANA is extensively utilized. Leadership: Proven track record of mentoring and leading technical teams, fostering a collaborative and innovative environment.
Delhi, Delhi, India
INR 10.0 - 14.0 Lacs P.A.
On-site
Full Time
Key Result Areas/outputs Activities . Ensure that all licensing for assigned products is complete in accordance with relevant norms Monitor status of product licenses Manage changes in product licenses and coordinate with other changes, planned and in progress Maintain complete documentation records Communicate changes to licenses status promptly Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch Maintain detailed knowledge of critical aspects of products: commercial strategies, the content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy Ensure that local regulatory strategies are consistent with global product strategies and local priorities Develop regulatory plan in conjunction with key stakeholders and ensure allocation of adequate resources and deliver plans on time Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch Provide Leadership and direction within project teams Strive to ensure high levels of performance and achievements. Take decisions and accountability for actions. Build commitment within the team. Enhance positive attitudes and mindset. Demonstrate confidence and conviction. Challenge the status quo for continuous improvement. Help build an open and trusting atmosphere Assist in Issues. Interact with relevant regulatory authorities on a regular basis to facilitate the process of obtaining necessary approvals/permissions Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products Communicate the impact of changes to key stakeholders. Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes Develop excellent relationships and partnerships with Regulatory Authorities Competitive Intelligence and Analysis Monitor the global pipelines of competing pharmaceutical companies Analyse gathered the information for its impact on AstraZeneca s proposed pipelines Provide a scenario with options and a risk-benefit analysis for AstraZeneca going forward
Mumbai, Maharashtra, India
INR 10.0 - 14.0 Lacs P.A.
On-site
Full Time
Key Result Areas/outputs Activities . Ensure that all licensing for assigned products is complete in accordance with relevant norms Monitor status of product licenses Manage changes in product licenses and coordinate with other changes, planned and in progress Maintain complete documentation records Communicate changes to licenses status promptly Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch Maintain detailed knowledge of critical aspects of products: commercial strategies, the content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy Ensure that local regulatory strategies are consistent with global product strategies and local priorities Develop regulatory plan in conjunction with key stakeholders and ensure allocation of adequate resources and deliver plans on time Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch Provide Leadership and direction within project teams Strive to ensure high levels of performance and achievements. Take decisions and accountability for actions. Build commitment within the team. Enhance positive attitudes and mindset. Demonstrate confidence and conviction. Challenge the status quo for continuous improvement. Help build an open and trusting atmosphere Assist in Issues. Interact with relevant regulatory authorities on a regular basis to facilitate the process of obtaining necessary approvals/permissions Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products Communicate the impact of changes to key stakeholders. Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes Develop excellent relationships and partnerships with Regulatory Authorities Competitive Intelligence and Analysis Monitor the global pipelines of competing pharmaceutical companies Analyse gathered the information for its impact on AstraZeneca s proposed pipelines Provide a scenario with options and a risk-benefit analysis for AstraZeneca going forward
Chennai, Tamil Nadu, India
INR 3.0 - 7.0 Lacs P.A.
On-site
Full Time
Essential Skills/Experience Strong analytical and problem-solving skills People management experience Strong knowledge on databases and database concepts, SQL, analytical tools Familiarity with MS Office Tools - Word, Excel, PowerPoint Document processes and adhere to standard operating procedures and processes Basic project management skills and be detail oriented Capable of managing multiple projects/requests simultaneously Work in teams, Collaborate and ensure Compliance Basic to limited exposure to issue/ticket management and/or tracking tools (ex: JIRA, ServiceNow) Desirable Skills/Experience Exposure to MDM tools and systems - Reltio, Veeva Good experience in Process transitions, Building teams & Process Maturity model Familiarity with tools like PowerBI, Snowflake, Python Industry Data knowledge - OneKey, Veeva Open Data, Definitive Health Care data, Payer Data etc.
Nellore, Andhra Pradesh, India
INR 3.0 - 8.0 Lacs P.A.
On-site
Full Time
Key Duties and Accountabilities Develop account strategy and plans Identify opportunities and strategies to improve positioning of AZs R&I products at a local level. Work with Sales Manager to develop a local strategy and business plan to meet targets and further improve positioning of AZs R&I products at a local level. Create deep stakeholder relationships Engage R&I HCPs in dialogue about approved indications, product efficacy / safety profiles and treatment protocols to support on-label prescribing for appropriate patients. Establish and maintain ongoing, long term collaborative relationships with stakeholders. Share stakeholder insight and information within AZ to strengthen relevant activities, e.g., product development, marketing, sales efforts. Build capability and knowledge in healthcare eco-system Build knowledge and understanding about AZs overall R&I value proposition, and products labeled indications and efficacy data among all relevant stakeholders in the MDT and DMU. Utilize different communication approaches, techniques, and channels to help build knowledge in the MDT and DMU, including. Conduct science-based discussions with the HCP as per the approved indications of AZs products. Arrange multidisciplinary workshops for physicians and other healthcare professionals. Arrange and coordinate effective speaker programmes with physician advocates and KOLs. Actively support R&I nurses on relevant trainings, e.g., chemotherapy, testing solutions. Deliver on plans and achieve sales goals on budget Drive sales performance and ensure sales forecasts meet or exceed expectations while managing assigned budgets. Successfully promote the benefits of AZs R&I brands, using fair balance messages and the appropriate mix of promotional tools. Ensure AZs products are optimally utilized in line with national/local guidelines and the product license. Be compliant Successfully complete all training requirements, including product examinations. Comply with all external regulations and internal policies. Ensure compliance with the AZ Code of Ethics, Global External Interactions Policy and Standards, and Privacy Policy and Standards, especially when interacting with Patient Groups. Essential for the role University Science graduate, ideally MBA from reputable institute. Proficient in oral and written communication (English). Must have 3+ years of sales experience with Pharma sector in R&I domain. Should have been a high performer in sales, Cross functional engagement, strong business acumen. Organizational skills, good analytical skills / mind set, ability to manage complexity with a high degree of maturity.
Mumbai, Maharashtra, India
INR 3.0 - 7.5 Lacs P.A.
On-site
Full Time
Roles & Responsibilities: Accountable for Zero Breach in Tender submission by adhering to public channel SOP. Detailed reading of the Tender Terms and conditions. Prepare &submitthe pre-bid representation in coordination with the Tender Manager & Sales Force. Coordinate with CFTs (Sales / Finance / Ops / Regulatory / Operations / SOTC and Quality) for related documentations and approvals. Closely workwith the tender manager in representing for waiver or counter offers during participation. Compilation of the documentation for Tender and conduct internal QC with Tender Manager & Sales 48 hrs prior to the Tender submission timelines. Fulfil the deficiencies raised by TM or Sales. Submission of tenders in time with accuracy (with 0 deficiency) to ensure the technical qualification. Follow up on the Technical and price bid opening. Handover to Tender Support in case of awarded RC/LoA Recording all-tender related documents for future reference SKILLS AND CAPABILITIES NEEDED Subject Knowledge : Should have strong knowledge of regulatory & statutory documentation requirement for submission of theTender Process Knowledge: Strong understanding of the Govt. Portals & Gem Portal. Knowledge of the process for tender/corrigendum download & submission of tenders isrequired. Communication Skills: Should be flawless in written & spoken English. Comprehension & Interpretation : Should be able tocomprehendthe terms & conditions of the tender and interpret the same correctly to the stakeholders. Collaboration & Coordination : should havevery goodcollaborative skills to coordinate with multiple stakeholders for requirements in the Tender. Proactiveness & Time Management : Should be able to manage time well tosubmitthe tenders well before the timelines. Essential Educational Qualification: B.Pharm/Bachelors Degreein any discipline with 3 years of experience in the Govt. tender participation for Pharma company Experience inGeMtender submissions. Desirable for the role : AdvancedMicrosoft office skills Reading & understanding of Hindiis an advantage.
Bengaluru / Bangalore, Karnataka, India
INR 7.0 - 9.5 Lacs P.A.
On-site
Full Time
Support development of technical programming specifications for SDTM, ADS or ADaM standards. Independently develop and/or validate programs that generate SDTM, and analysis datasets based on Alexion or ADaM specifications. Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP. Independently develop and validate programs that generate tables, listings, figures/graphs using Alexion specifications. Manage external vendors and contract programmers. Provide project progress updates of programming activities. Review, maintain, and approve protocol specific documents as necessary. Provide guidance and mentoring to peer, junior-level Programmers and contract staff. Support project leadership ensuring that department standards are implemented in all studies. Contribute ideas and thoughts towards the optimization of standard operating procedures. Lead team meetings when appropriate. Any other activities as required. Essential Skills/Experience: Minimum of 6 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members High competence in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Knowledge and implementation of: SDTM and ADaM principals Relational Databases. Good Clinical Practice principals. Good Programming Practice principals. 21CFR Part 11 Standards principals. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format.
Bengaluru / Bangalore, Karnataka, India
INR 4.0 - 10.0 Lacs P.A.
On-site
Full Time
Essential Skills/Experience: PhD or Masters or equivalent experience in a relevant scientific field with 4+ years of industrial experience. A strong background in pharmacology (e.g., pharmacology, biology, biochemistry, toxicology, physiology) with a proven track record in driving innovative science, preferably in the pharmaceutical or biotechnology industry. Technical experience in in vitro pharmacological or biochemical assay development and screening (e.g., kinase profiling technologies, radioligand binding, enzyme activity, and functional cell-based systems) applied to various biological target classes. Excellent problem-solving and organisational skills, delivery focus, and outstanding communication skills. A true collaborator with highly effective networking skills and experience collaborating across scientific disciplines, cultures, and expertise. Desirable Skills/Experience: Experience with off-target profiling data and strategies in the pharmaceutical industry. Practical understanding of kinase profiling technologies. Experience working with CRO s, commissioning requests and driving delivery processes. Experience with being entrepreneurial taking the initiative in projects. Demonstrated leadership in scientific projects or teams. Experience in regulatory interactions or safety assessments. Knowledge of emerging trends in drug safety and pharmacovigilance.
Bengaluru / Bangalore, Karnataka, India
INR 7.0 - 10.5 Lacs P.A.
On-site
Full Time
Leads Implementation of statistical programming aspects of the protocol or clinical development program Responsible for the high quality of all project deliverables, holding partners and providers accountable for the quality of their deliverable and/or technical subject matter expert for aspect(s) of the TA, Project, or function Leads or contributes to cross-functional administrative or process improvement initiative(s) Drives the development of best practices to improve quality, efficiency, and/or effectiveness within the function Drives standards development and implementation Manages and escalates risk in complicated or novel situations within their study and/or projects Provides Programming expertise to the team Provides tactical input and/or drives ideas and improvements Contributes to the function by supporting recruiting and/or providing training and mentorship Finds opportunities to improve methodology and provides practical solutions for problems Manages activities of our external partners (i.e., Contract Research Organisations) Influences collaborators by providing subject matter expertise on programming-related items Ensures compliance with standards and automation usage Employs all project management practices in managing drug or technical projects Provides input to capacity management for all projects in scope Maintains expertise in the latest industry and regulatory requirements to stay current Essential Skills/Experience Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science or equivalent Proven programming expertise Thorough knowledge of the clinical development process Thorough knowledge of industry standards and ability to implement them Ability to apply programming expertise to problem-solving and troubleshooting for teams Current knowledge of technical and regulatory requirements relevant for the role Ability to proactively manage concurrent activities within a project Proficient ability to influence relevant stakeholders on programming-related items Ability to manage risk in complicated or novel situations Project Mindset
Chennai, Tamil Nadu, India
INR 1.0 - 2.5 Lacs P.A.
On-site
Full Time
KeyResponsibilities: Facilitate key discussions with various stakeholders as requested by system owner/platform lead and provide SME technical support on system testingof the Core EDC Product,and anydata integrations (in and out)of EDC. Perform impact analysis for any change that happens on the EDCsystem Work with business and perform risk assessment during change implementations/systemupgradesor updates tointegrations Follow andparticipatein validation lifecycle for upgrades, changes, & new integrations Co-develop validation packagesin accordance withstandard operating procedures (SOPs). Provide support of code review and solutioningfor downstream customer requirements, including data extraction methods (SQL, Webservices, APIs) Activelyparticipatein business meetings and bringnew ideasto thetable Responsibleto solveday-to-day incidents, service requests andworktowards incident-reduction and automation. Also, update Service Now (ticket management tool) for all events with respect to the incidents, service requests,changesand problems. Constantly thrive to learn and upskill according to the organization s goals and demands. CreateGxpValidation Test cases inJiraXrayfor system/upgradetesting Perform validationtest executions in Jira Xray,for bothsystem testingand regression testing. Assistin creating or create UAT test cases that cover the essential business scenarios/use casesfor the business. Facilitateprocess requirementsgathering:capturing user stories, requirement analysis, data analysis, programming, database management, and systems integration. Mandatory Skills Extensive experience of usingMedidataRAVE UI(Classic or Rave EDC)to perform the following actions: Study build, edit checks programming, deployment to production andmigration Understanding aboutdifferent rolesand permissions in Rave Understanding of core configuration and clinical views Understanding of what data extraction capabilities there are Hands on Experience of Inbound Rave Web Services (egIVRS or discrepancy inputs) Experience of setting up Rave safety gateway (RSG) and SAE notifications Experience of setting up SAS extracts Experience on setting up Target Source Data Verification (TSDV) Hands on experience of being involved in URL upgrade(s) (Medidata release updates) Knowledge on system validation process / Application Life Cycle Management Must havestrong communicationskills and interpersonalskills Responsible to work on technical tasks to keep the Rave URL(s) andit sintegrations in a maintained state Adhere to AZ core ITIL guidelines and perform tasks as incident, change, problem etc. Working experience in clinicalstandard anddatacollection, clinical data conversion or clinical data programming/testing. Understandingof CDASH, SDTM,ADaMCDISC controlled TerminologyandFDA/ICH guidelines for clinical studydata Effective in stakeholder management, translating technical concepts, and working within team environments. Skilled in project management basics and creating clear technical documentation. Preferred Skills Hands on Experience of custom function,SASprogramming Knowledge on Coder/ Coder+setup&Lab setup Hands on Experience of outbound Rave Web Services (ODM Adapter, Biostats Adapter) Hands on Experience of Rave backend data model,sqlscript writing, stored procedures Hands-on knowledge in agile management tools like Service NOW Hands-on experience in performing system testing including authoring and executing testcases Passion for learning, innovating, and delivering valuable software to people. Any other programming languages/technical skillse.g: Python, JAVA, etc. Knowledge of other Medidata products and/or Cloud EDCtesting(Rave/Inform/Veeva)experience. Educational Requirements Bachelor or master sdegree in computer science or life science related discipline with IT/CRO/Pharma experience with total of8+ years of experience
Bengaluru / Bangalore, Karnataka, India
INR 1.0 - 3.5 Lacs P.A.
On-site
Full Time
Essential Skills/Experience: Degree Qualified - Pharmacy/ Medical/ Science Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry Thorough knowledge of the current pharmacovigilance and regulatory developments Experience in working cross-functionally Ability to set and manage priorities, resource goals and project initiatives Ability to influence strategically to obtain desired outcomes while maintaining effective, positive organisational relationships Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience: Degree Qualified - Pharmacy/ Medical/ Science Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry Thorough knowledge of the current pharmacovigilance and regulatory developments Experience in working cross-functionally Ability to set and manage priorities, resource goals and project initiatives Ability to influence strategically to obtain desired outcomes while maintaining effective, positive organisational relationships
Bengaluru / Bangalore, Karnataka, India
INR 1.0 - 2.5 Lacs P.A.
On-site
Full Time
KeyResponsibilities: Facilitate key discussions with various stakeholders as requested by system owner/platform lead and provide SME technical support on system testingof the Core EDC Product,and anydata integrations (in and out)of EDC. Perform impact analysis for any change that happens on the EDCsystem Work with business and perform risk assessment during change implementations/systemupgradesor updates tointegrations Follow andparticipatein validation lifecycle for upgrades, changes, & new integrations Co-develop validation packagesin accordance withstandard operating procedures (SOPs). Provide support of code review and solutioningfor downstream customer requirements, including data extraction methods (SQL, Webservices, APIs) Activelyparticipatein business meetings and bringnew ideasto thetable Responsibleto solveday-to-day incidents, service requests andworktowards incident-reduction and automation. Also, update Service Now (ticket management tool) for all events with respect to the incidents, service requests,changesand problems. Constantly thrive to learn and upskill according to the organization s goals and demands. CreateGxpValidation Test cases inJiraXrayfor system/upgradetesting Perform validationtest executions in Jira Xray,for bothsystem testingand regression testing. Assistin creating or create UAT test cases that cover the essential business scenarios/use casesfor the business. Facilitateprocess requirementsgathering:capturing user stories, requirement analysis, data analysis, programming, database management, and systems integration. Mandatory Skills Extensive experience of usingMedidataRAVE UI(Classic or Rave EDC)to perform the following actions: Study build, edit checks programming, deployment to production andmigration Understanding aboutdifferent rolesand permissions in Rave Understanding of core configuration and clinical views Understanding of what data extraction capabilities there are Hands on Experience of Inbound Rave Web Services (egIVRS or discrepancy inputs) Experience of setting up Rave safety gateway (RSG) and SAE notifications Experience of setting up SAS extracts Experience on setting up Target Source Data Verification (TSDV) Hands on experience of being involved in URL upgrade(s) (Medidata release updates) Knowledge on system validation process / Application Life Cycle Management Must havestrong communicationskills and interpersonalskills Responsible to work on technical tasks to keep the Rave URL(s) andit sintegrations in a maintained state Adhere to AZ core ITIL guidelines and perform tasks as incident, change, problem etc. Working experience in clinicalstandard anddatacollection, clinical data conversion or clinical data programming/testing. Understandingof CDASH, SDTM,ADaMCDISC controlled TerminologyandFDA/ICH guidelines for clinical studydata Effective in stakeholder management, translating technical concepts, and working within team environments. Skilled in project management basics and creating clear technical documentation. Preferred Skills Hands on Experience of custom function,SASprogramming Knowledge on Coder/ Coder+setup&Lab setup Hands on Experience of outbound Rave Web Services (ODM Adapter, Biostats Adapter) Hands on Experience of Rave backend data model,sqlscript writing, stored procedures Hands-on knowledge in agile management tools like Service NOW Hands-on experience in performing system testing including authoring and executing testcases Passion for learning, innovating, and delivering valuable software to people. Any other programming languages/technical skillse.g: Python, JAVA, etc. Knowledge of other Medidata products and/or Cloud EDCtesting(Rave/Inform/Veeva)experience. Educational Requirements Bachelor or master sdegree in computer science or life science related discipline with IT/CRO/Pharma experience with total of8+ years of experience
Chennai, Tamil Nadu, India
INR 3.5 - 7.0 Lacs P.A.
On-site
Full Time
Accountabilities Strategic Leadership: Evaluate current platforms and lead the design of future-ready solutions, embedding AI-driven efficiencies and proactive interventions. Innovation & Integration: Introduce and integrate AI technologies to enhance ways of working, driving cost-effectiveness and operational excellence. Platform Maturity & Management: Ensure platforms are scalable and compliant, with robust automation and optimized technology stacks. Lead Deliveries: Oversee and manage the delivery of projects, ensuring timely execution and alignment with strategic goals. Thought Leadership: Champion data mesh and product-oriented work methodologies to continuously evolve our data landscapes. Quality and Compliance: Implement quality assurance processes, emphasizing data accuracy and security. Collaborative Leadership: Foster an environment that supports cross-functional collaboration and continuous improvement. Essential Skills/Experience Extensive experience with Snowflake, AI platforms, and cloud infrastructure. Proven track record in thought leadership, platform strategy, and cross-disciplinary innovation. Expertise in AI/GenAI integration with a focus on practical business applications. Strong experience in DataOps, DevOps, and cloud environments such as AWS. Excellent stakeholder management and the ability to lead diverse teams toward innovative solutions. Background in the pharmaceutical sector is a plus.
Chennai, Tamil Nadu, India
INR 7.0 - 15.0 Lacs P.A.
On-site
Full Time
Accountabilities As a Full Stack Data Engineer, you will: Develop, maintain, and optimize scalable data pipelines for data integration, transformation, and analysis, ensuring high performance and reliability. Demonstrate proficiency in ETL/ELT processes, including writing, testing, and maintaining high-quality code for data ingestion and transformation. Improve the efficiency and performance of data pipeline and workflows, applying advanced data engineering techniques and standard methodologies. Develop and maintain data models that represent data structure and relationships, ensuring alignment with business requirements and enhancing data usability. Develop APIs and microservices for seamless data integration across platforms and collaborate with software engineers to integrate front-end and back-end components with the data platform. Optimize and tune databases and queries for maximum performance and reliability and maintain existing data pipelines to improve performance and quality. Mentor other developers on standard methodologies, conduct peer programming, code reviews, and help evolve systems architecture to consistently improve development efficiency. Ensure compliance with data security and privacy regulations and implement data validation and cleansing techniques to maintain consistency. Stay updated with emerging technologies, standard methodologies in data engineering and software development, and contribute to all phases of the software development lifecycle (SDLC) processes. Work closely with data scientists, analysts, partners, and product managers to understand requirements, deliver high-quality data solutions, and support alignment of data sources and specifications. Perform unit testing, system integration testing, regression testing, and assist with user acceptance testing to ensure data solutions meet quality standards. Work with the QA Team to develop testing protocols and identify and correct challenges. Maintain clear documentation for Knowledge Base Articles (KBAs), data models, pipeline documentation, and deployment release notes. Diagnose and resolve complex issues related to data pipelines, backend services, and frontend applications, ensuring smooth operation and user satisfaction. Use and manage cloud-based services (e.g., AWS) for data storage and processing, and implement and manage CI/CD pipelines, version control, and deployment processes. Liaise with internal teams and third-party vendors to address application issues and project needs effectively. Create and maintain data visualizations and dashboards to provide actionable insights. Essential Skills/Experience Minimum 7+ years of experience in developing and delivering software engineering and data engineering solutions. Extensive experience with ELT/ETL tools such as SnapLogic, FiveTran, or similar. Deep expertise in Snowflake, DBT (Data Build Tool), and similar data warehousing technologies. Proficient in designing and optimizing data models and transformations for large-scale data systems. Strong knowledge of data pipeline principles, including dimensional modelling, schema design, and data integration patterns. Familiarity with Data Mesh and Data Product concepts, including experience in delivering and managing data products. Strong data orchestration skills to effectively manage and streamline data workflows and processes. Proficiency in data visualization technologies, with experience in advanced use of tools such as Power BI or similar. Solid understanding of DevOps practices, including CI/CD pipelines, version control systems like GitHub. Ability to implement and maintain automated deployment and integration processes. Experience with containerization technologies like Docker and orchestration tools like Kubernetes. Automated testing frameworks (Unit Test, system integration testing, regression testing & data testing). Strong proficiency in programming languages such as Python, Java, or Similar. Experience with both relational (e.g., MySQL, PostgreSQL) and NoSQL databases. Deep technical expertise in building software and analytical solutions with modern JavaScript stack (Node.js, ReactJS, AngularJS). Strong knowledge of cloud-based data, compute, and storage services, including AWS (S3, EC2, RDS, EBS, Lambda), orchestration services (e.g., Airflow, MWAA), containerization services (e.g., ECS, EKS). Excellent communication and interpersonal skills, with a proven ability of managing partner expectations, gathering requirements, translating them into technical solutions. Experience working in Agile development environments, with a strong understanding of Agile principles and practices. Ability to adapt to changing requirements and contribute to iterative development cycles. Advanced SQL skills for data analysis. Expertise on problem-solving skills with a focus on finding innovative solutions to complex data challenges. Strong analytical and reasoning skills, with the ability to visualize processes and outcomes. Strategic thinker with a focus on finding innovative solutions to complex data challenges. Desirable Skills/Experience Bachelors or Masters degree in health sciences, Life Sciences, Data Management, Information Technology or a related field or equivalent experience. Significant experience working in the pharmaceuticals industry with a deep understanding of industry-specific data requirements. Demonstrated ability to manage and collaborate with a diverse range of partners ensuring high levels of satisfaction and successful project delivery. Proven capability to work independently and thrive in a dynamic fast-paced environment managing multiple tasks adapting to evolving conditions. Experience working in large multinational organizations especially within pharmaceutical or similar environments demonstrating familiarity with global data systems processes. Certification in AWS Cloud or other relevant data engineering or software engineering certifications showcasing advanced knowledge technical proficiency. Awareness of use case specific GenAI tools available in the market and their application in day-to-day work scenarios. Working knowledge of basic prompting techniques and commitment to continuous improvement of these skills. Ability to stay up to date with developments in AI and GenAI, applying new insights to work-related situations.
Chennai, Tamil Nadu, India
INR 10.0 - 14.5 Lacs P.A.
On-site
Full Time
Bridge business needs with technical solutions by leading IT application design and implementation. Collaborate with partners to define and deliver requirements, translating them into detailed specifications. Own the technical vision of products and compile detailed technical designs, refining user Epics/stories. Optimize performance, mitigate risks, and ensure alignment to timelines and resource allocations. Advise on industry trends and standard methodologies to enhance performance and business outcomes. Provide technical direction and guidance to IT teams and business units. Contribute to Data & Software Engineering standards and best practices. Research new technologies to boost system performance and scalability. Lead and mentor technical teams (Data Engineering, Cloud Engineering, Software Engineering) and work with AI/GenAI leads to foster collaboration and innovation. Ensure platform stability, scalability, and simplicity while adhering to regulatory requirements and data security standards. Foster continuous improvement and innovation. Oversee technical leadership throughout the software development lifecycle and provide hands-on support in development, technical delivery, review, and testing while collaborating with global teams. Apply central Enterprise Data Platforms and guide DevOps, DataOps, and MLOps teams to ensure standard methodologies. Ensure data solutions stay in sync with FAIR principles and support end-to-end data science and machine learning. Essential Skills/Experience Minimum 10+ years in developing and delivering software engineering and data engineering solutions. Strong problem-solving skills with a focus on high-quality solutions. Deep technical expertise in data engineering, cloud patterns (e.g., microservices, serverless), and software engineering principles. Proficiency in containerization (Docker, Kubernetes), databases (SQL, NoSQL), CI/CD pipelines, and automated deployment tools. Leadership experience in mentoring and team management. Fluency in Python and Java; knowledge of security and data protection. Familiarity with DevOps tools, DataOps principles, and Data Mesh concepts. Hands-on experience with AWS Compute Services, Apache Airflow, Snowflake, Power BI, and NodeJS. Strong understanding of AI Engineering and implementation of AI/ML models using Amazon SageMaker. Experience in Agile methodologies and product development/management. Desirable Skills/Experience Bachelors or masters degree in health sciences, Life Sciences, Data Management, IT, or a related field. Experience in the pharmaceutical industry or a similar multinational environment. AWS Cloud or relevant data/software engineering certifications. Awareness of use case specific GenAI tools available in the market and their application in day-to-day work scenarios. Working knowledge of basic prompting techniques and commitment to continuous improvement of these skills. Ability to stay up to date with developments in AI and GenAI, applying new insights to work-related situations.
Chennai, Tamil Nadu, India
INR 4.5 - 9.0 Lacs P.A.
On-site
Full Time
Accountabilities 4+ years of proven ability in Snaplogic Own development work assigned for each release/project in Mulesoft. Understand business requirements and ensure implementation is reviewed by tech leads. Ensure effective downstream integration and data quality fit for business purposes. Complete tech assessments for each CR, log in JIRA, and follow AGILE methodology. Troubleshoot integrations. Create documents related to implementation and ensure transition to service. Coordinate with Test and Release engineering team for defect management and successful deployment of improvements to production tenants. Essential Skills/Experience Development experience of working in Sales & Marketing Portfolio preferably in Life Sciences Industry. Technical hands-on experience in: ETL Technology: Snaplogic or any ETL Tool iPass: Databricks Database: Oracle/Postgres, SQL, PL/SQL Hands-on experience in LLM, Python, Java, ML is an added advantage. Hands-on experience in APIs, Postman, Rest Services. Integrating with Salesforce is an added advantage. Good understanding of Data Process Flow Configurations & Designs. Experience with Web Services Integration and APIs. Experience in the CICD process. Experience in Agile methodology. Superb communication, interpersonal, and organizational skills. Ability to solve complex problems. Work as a member of a team. Ability to meet tight deadlines. Ability to decipher highly technical data. Ability to multi-task in a constantly evolving work environment.
Bengaluru / Bangalore, Karnataka, India
INR 7.0 - 12.0 Lacs P.A.
On-site
Full Time
What youll do: Ensure all work is performed in accordance with established procedures, regulatory requirements, and GxPs. Serve as the point of contact for managing all labeling/artwork requests for allocated products requiring market/regulatory approval in the US, markets receiving a standard export pack, and EU centralized procedures. Coordinate and/or lead the development and lifetime maintenance of packaging component labeling for commercial products, including new pack introductions, product launches, updates to existing packs, and mock-ups for regulatory submissions. Collaborate with marketing company colleagues regarding global artworks as appropriate. Engage with operations/manufacturing sites regarding implementation of global artworks as needed. Ensure proper version control and document integrity of packaging component labeling, printed labeling artworks, and other assigned labeling documents. Process and prepare all final printed labeling for the US and required EU specimens for submission. Essential Skills/Experience: Relevant university degree in science or related discipline Minimum 7 years of regulatory experience within the biopharmaceutical industry, preferably working with labeling Keen attention to detail and accuracy Thorough knowledge of labeling regulations and guidance Strong project management skills Leadership skills, including experience leading multi-disciplinary project teams Desirable Skills/Experience: Experience in packaging labeling development and/or maintenance Experience working with stakeholders from locations outside of India, especially Europe and/or USA
Bengaluru / Bangalore, Karnataka, India
INR 1.0 - 3.5 Lacs P.A.
On-site
Full Time
Essential Skills/Experience: Degree Qualified - Pharmacy/ Medical/ Science Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry Thorough knowledge of the current pharmacovigilance and regulatory developments Experience in working cross-functionally Ability to set and manage priorities, resource goals and project initiatives Ability to influence strategically to obtain desired outcomes while maintaining effective, positive organisational relationships Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience: Degree Qualified - Pharmacy/ Medical/ Science Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry Thorough knowledge of the current pharmacovigilance and regulatory developments Experience in working cross-functionally Ability to set and manage priorities, resource goals and project initiatives Ability to influence strategically to obtain desired outcomes while maintaining effective, positive organisational relationships
Pharmaceutical Manufacturing
10001 Employees
96 Jobs
Key People
My Connections Astrazeneca
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.