248 Argus Jobs - Page 3

Title Due to our continued growth, we are in need of qualified and focused individuals, like yourself. This is a vital role with our Clinical Safety team whose success relies upon your finely tuned skills and background. If you are ready to make a difference, you must be able to accomplish these tasks: Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Implementation of routine system configuration including product, study and license in Argus and Argus J; Assist with creating reports using Oracle Business Intelligence reporting tool; Resolve safety database-related issues; Prepare/Execute User Acceptance Testing (UAT) of safety system changes; Assist in Argus Database Training for new users, as applicable; Generate outputs from the global safety system in support of periodic safety reports (e.g. DSUR, PSUR and PBRER) ; Assist in the development of system support related process, SOPs, Work Instructions and manuals and Support Inspection and Audits. Qualifications Bachelor’s Degree in scientific discipline or Business Informatics or similar area with 1-2 years of directly related experience; Preferred Qualifications: Work experience in CRO/biotech/pharmaceutical industry. Experience in Study configurations in Safety Systems. Experience with Safety Database preferably Argus and Argus J. Experience in SQL. Experience in reporting and analytic platforms such as OBIEE. Strong client service orientation. Strong consultative problem-solving skills. Ability to combine technical problem-solving skills with discernment to resolve best business solution. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Description News Editor Mumbai About Argus: Argus is the leading independent provider of market intelligence to the global energy and commodity markets. We offer essential price assessments, news, analytics, consulting services, data science tools and industry conferences to illuminate complex and opaque commodity markets. Headquartered in London with 1,500 staff, Argus is an independent media organisation with 30 offices in the world’s principal commodity trading hubs. Companies, trading firms and governments in 160 countries around the world trust Argus data to make decisions, analyse situations, manage risk, facilitate trading and for long-term planning. Argus prices are used as trusted benchmarks around the world for pricing transportation, commodities and energy. Founded in 1970, Argus remains a privately held UK-registered company owned by employee shareholders and global growth equity firm General Atlantic. What we’re looking for: The news editor will be responsible for editing Argus news stories, market commentaries and other written publications as part of the Asian editing team. The news editor will focus on publishing accurate and timely information for Argus’ online platforms and business intelligence reports, as well as maintaining and improving the quality of the company’s editorial output. What will you be doing: To edit copy for Argus online news service, market publications and business intelligence reports To ensure the highest standards of spelling, punctuation, grammar, accuracy and consistency in all published material To recognise errors in copy and to improve the quality when required. To maintain strong working relationships with reporters and other editorial staff To write news and analysis stories where necessary Skills and Experience: At least 1-2 years of news or copy-editing experience at a recognised publication High degree of understanding regarding grammar, spelling and punctuation Ability to write in clear and concise English. Understanding of what constitutes good news story. Experience of working to strict deadlines Ability to work with minimum supervision within a team structure. Experience with editing business news, particularly commodities, would be a strong advantage. Attributes Self-motivated, confident and results driven individual Highly organised to manage own workload and efficiently meet targets Courteous, friendly, and positive What’s in it for you: Competitive Compensation: Enjoy a rewarding salary package coupled with an enticing company bonus scheme, acknowledging your contributions and incentivizing your continued excellence. Flexibility Redefined: Embrace a hybrid working model that seamlessly blends the best of both worlds—three days in the vibrant office environment and two days of productive work from home, fostering work-life balance and maximizing productivity. Wellness Assurance: Prioritize your health and well-being with comprehensive group healthcare coverage, ensuring peace of mind for you and your loved ones. Time to Recharge: Rejuvenate and recharge with generous annual leave entitlement of 18 days, including additional 8 days of casual leave to unwind and pursue personal interests. Continuous Growth: Embark on a journey of continuous learning and development with extensive internal and external training opportunities, empowering you to stay at the forefront of industry trends and sharpen your skills. Hours: This is a full-time position operating under a hybrid model, with three days in the office and two days working remotely. Office hours are Monday through Friday from 09:00 to 18:00, with a one-hour lunch break. For more details about the company and to apply please make sure you send your CV and cover letter via our website: www.argusmedia.com/en/careers/open-positions By submitting your job application, you automatically acknowledge and consent to the collection, use and/or disclosure of your personal data to the Company. Argus is an equal opportunity employer. We welcome and encourage diversity in the workplace regardless of race, gender, sexual orientation, gender identity, disability or veteran status. Show more Show less

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Analyst Qualifications: BCom Years of Experience: 3 to 5 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model. The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business. Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Show more Show less

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Analyst Qualifications: BCom Years of Experience: 3 to 5 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model. The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business. Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Physiotheraphy Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Junior Drug Safety AssociateJunior Drug Safety Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Physiotheraphy

Job Description: Director Technology Location: Hyderabad, India At AT&T, we are redefining the future of communication by connecting people to greater possibility – with expertise, simplicity, and inspiration . At the heart of our purpose lies a diverse workforce of around 140,000 people and a culture that aspires to serve customers first, act boldly, move faster, and win as one. The AT&T Technology Services (ATS) organization is helping AT&T modernize its legacy IT infrastructure and migrate as much of it as possible to the cloud while retiring outdated systems. In addition, ATS includes network, business, and consumer technology platforms as well as experts developing new products and services built on AT&T’s leading-edge 5G and fiber connectivity. Our CIO group, part of AT&T’s Technology Services (ATS) organization, is responsible for advancing information technology performance and delivering technical solutions with a focus on return on investment and increasing efficiency while improving quality and enhancing the experience of end users. Job Overview We are seeking a dynamic and results-driven Software Development Director to lead our development and support programs, responsible for driving innovation, delivering value-added solutions, and ensuring operational excellence across the organization. The ideal candidate will have a strong background in cross-platform software engineering, experience of growing teams and delivering projects with expertise in DevOps, Azure Cloud Platform, Java Full Stack development, TM Forum API frameworks, and exceptional leadership skills to inspire and guide high-performing teams. Key Responsibilities: Strategic Leadership: Define and execute the strategic roadmap for development and support programs, aligning with the overall objectives of the CIO group. Foster a culture of innovation, continuous improvement, and collaboration across cross-functional teams. Program Management: Oversee the design, development, and delivery of scalable, secure, and high-quality software solutions. Lead the adoption of DevOps principles, ensuring streamlined CI/CD pipelines and operational efficiency. Manage multiple development and support initiatives with a focus on timelines, budgets, and deliverables. Drive improvements through DORA metrics. Cloud Expertise: Drive the successful implementation and optimization of solutions on the Azure Cloud Platform, ensuring scalability, availability, and cost efficiency. Technical Leadership: Provide technical design and architectural leadership to multiple teams and projects to help ensure applications are integrated and adhere to stated architectural and design principles and industry standards. Leverage deep knowledge of TM Forum APIs to drive interoperability and seamless integration with industry standards. People Management: Lead, mentor, and inspire a diverse team of engineers, developers, and support staff, fostering a culture of ownership and accountability. Develop career growth opportunities and ensure the team has the skills and tools necessary for success. Build a collaborative and inclusive work environment to attract and retain top talent. Stakeholder Engagement: Collaborate with internal and external stakeholders to identify business needs, provide innovative solutions, and ensure alignment of IT initiatives with organizational goals. Communicate effectively with executive leadership, providing regular updates on project progress, risks, and opportunities. Qualifications: Bachelor’s degree in computer science, Information Technology, or a related field (Master’s degree preferred). 15+ years of experience in software development, with at least 5 years in a leadership role managing development and support programs. Proven experience in driving innovation and delivering value-added solutions in a fast-paced environment. Expertise in DevOps principles and tools (e.g., Jenkins, Docker, Kubernetes). In-depth knowledge of Azure Cloud Platform architecture and services (e.g., Azure DevOps, Azure Kubernetes Service, Azure Functions). Strong technical background in Java Full Stack development (e.g., Spring Boot, Angular/React, microservices architecture). Demonstrated ability to lead large, distributed teams with a proven track record of people leadership and team building. Exceptional problem-solving skills, with the ability to balance technical and business priorities effectively. Experience in budget management, vendor negotiations, and resource allocation. Preferred Skills: Knowledge on TM Forum APIs, GenAI and their application in telecom/enterprise environments. Knowledge of emerging technologies and trends in the IT and telecom sectors. Experience in fostering partnerships with business leaders and external vendors. Exposure to SaaS solutions like ServiceNow, Workday, Oracle Financials Weekly Hours: 40 Time Type: Regular Location: IND:AP:Hyderabad / Argus Bldg 4f & 5f, Sattva, Knowledge City- Adm: Argus Building, Sattva, Knowledge City It is the policy of AT&T to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, AT&T will provide reasonable accommodations for qualified individuals with disabilities. AT&T is a fair chance employer and does not initiate a background check until an offer is made. Job ID R-70288 Date posted 06/06/2025 Benefits Your needs? Met. Your wants? Considered. Take a look at our comprehensive benefits. Paid Time Off Tuition Assistance Insurance Options Discounts Training & Development

Job Description: Weekly Hours: 40 Time Type: Regular Location: IND:AP:Hyderabad / Argus Bldg 4f & 5f, Sattva, Knowledge City- Adm: Argus Building, Sattva, Knowledge City It is the policy of AT&T to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, AT&T will provide reasonable accommodations for qualified individuals with disabilities. AT&T is a fair chance employer and does not initiate a background check until an offer is made.

Description Associate Data Engineer – Pricing Fixed Term Contract – 18 months About Argus: Argus is the leading independent provider of market intelligence to the global energy and commodity markets. We offer essential price assessments, news, analytics, consulting services, data science tools and industry conferences to illuminate complex and opaque commodity markets. Headquartered in London with 1,500 staff, Argus is an independent media organisation with 30 offices in the world’s principal commodity trading hubs. Companies, trading firms and governments in 160 countries around the world trust Argus data to make decisions, analyse situations, manage risk, facilitate trading and for long-term planning. Argus prices are used as trusted benchmarks around the world for pricing transportation, commodities and energy. Founded in 1970, Argus remains a privately held UK-registered company owned by employee shareholders and global growth equity firm General Atlantic. What we’re looking for: Due to the continued growth of the business and the importance of the data we use on a daily basis, we are currently looking for a for a junior data engineer to join our global Data team in Mumbai. You will work closely with internal clients of the data team to support and maintain R (incl. R Shiny), Excel and database-based processes for gathering data, calculating prices and producing the reports and data feeds. The work also involves writing robust automated processes in R. The team supports Argus’ key business processes every day, as such you will be required to work on a shift-based rota with other members of the team supporting the business until 8pm. Typically support hours run from 11pm to 8pm with each member of the team participating 2/3 times a week. What will you be doing? Support and development of data processing systems Client support with queries relating to integration of Argus data and metadata into client systems data validation provision of data Data and systems support to Argus’ staff Project development Maintenance and development of existing systems metadata modification data cleansing data checking Skills and Experience: Significant recent experience of developing tools using R (incl., R Shiny applications) in a commercial (work) environment. Good knowledge and experience of SQL, preferably in Oracle or MySQL, including stored procedures, functions, and triggers. Experience with version control systems (e.g., Git) and Unit Testing in R is required. Ability to work both as part of a team and autonomously Excellent communication skills Desired Skills and Experience: BS degree in Computer Science, Mathematics, Business, Engineering or related field. Experience in visualisation techniques is desirable. Any experience working with energy markets and commodities data is highly desirable Experience developing production-grade scalable applications in R. Personal Attributes: Ability to interact with non-technical people in plain language Innovative thinker with good problem-solving abilities and attention to detail Numerically proficient Self-motivated with ability to work independently, prioritising tasks to meet deadlines Customer service focused Benefits: Competitive salary Flexible Working Policy Group healthcare scheme 18 days annual leave 8 days casual leave Extensive internal and external training Please send in your application via our official careers website at https://www.argusmedia.com/en/careers/open-positions. Jobs posted on other websites and that do not link to our careers website may not be legitimate and may be fraudulent. If you are contacted by someone whom you suspect may not be appropriately representing Argus, please send the details to us via an email with “Recruitment Fraud” in the subject title. Show more Show less

Job Description: Director Technology Location: Hyderabad, India At AT&T, we are redefining the future of communication by connecting people to greater possibility – with expertise, simplicity, and inspiration . At the heart of our purpose lies a diverse workforce of around 140,000 people and a culture that aspires to serve customers first, act boldly, move faster, and win as one. The AT&T Technology Services (ATS) organization is helping AT&T modernize its legacy IT infrastructure and migrate as much of it as possible to the cloud while retiring outdated systems. In addition, ATS includes network, business, and consumer technology platforms as well as experts developing new products and services built on AT&T’s leading-edge 5G and fiber connectivity. Our CIO group, part of AT&T’s Technology Services (ATS) organization, is responsible for advancing information technology performance and delivering technical solutions with a focus on return on investment and increasing efficiency while improving quality and enhancing the experience of end users. Job Overview We are seeking a dynamic and results-driven Software Development Director to lead our development and support programs, responsible for driving innovation, delivering value-added solutions, and ensuring operational excellence across the organization. The ideal candidate will have a strong background in cross-platform software engineering, experience of growing teams and delivering projects with expertise in DevOps, Azure Cloud Platform, Java Full Stack development, TM Forum API frameworks, and exceptional leadership skills to inspire and guide high-performing teams. Key Responsibilities: Strategic Leadership: Define and execute the strategic roadmap for development and support programs, aligning with the overall objectives of the CIO group. Foster a culture of innovation, continuous improvement, and collaboration across cross-functional teams. Program Management: Oversee the design, development, and delivery of scalable, secure, and high-quality software solutions. Lead the adoption of DevOps principles, ensuring streamlined CI/CD pipelines and operational efficiency. Manage multiple development and support initiatives with a focus on timelines, budgets, and deliverables. Drive improvements through DORA metrics. Cloud Expertise: Drive the successful implementation and optimization of solutions on the Azure Cloud Platform, ensuring scalability, availability, and cost efficiency. Technical Leadership: Provide technical design and architectural leadership to multiple teams and projects to help ensure applications are integrated and adhere to stated architectural and design principles and industry standards. Leverage deep knowledge of TM Forum APIs to drive interoperability and seamless integration with industry standards. People Management: Lead, mentor, and inspire a diverse team of engineers, developers, and support staff, fostering a culture of ownership and accountability. Develop career growth opportunities and ensure the team has the skills and tools necessary for success. Build a collaborative and inclusive work environment to attract and retain top talent. Stakeholder Engagement: Collaborate with internal and external stakeholders to identify business needs, provide innovative solutions, and ensure alignment of IT initiatives with organizational goals. Communicate effectively with executive leadership, providing regular updates on project progress, risks, and opportunities. Qualifications: Bachelor’s degree in computer science, Information Technology, or a related field (Master’s degree preferred). 15+ years of experience in software development, with at least 5 years in a leadership role managing development and support programs. Proven experience in driving innovation and delivering value-added solutions in a fast-paced environment. Expertise in DevOps principles and tools (e.g., Jenkins, Docker, Kubernetes). In-depth knowledge of Azure Cloud Platform architecture and services (e.g., Azure DevOps, Azure Kubernetes Service, Azure Functions). Strong technical background in Java Full Stack development (e.g., Spring Boot, Angular/React, microservices architecture). Demonstrated ability to lead large, distributed teams with a proven track record of people leadership and team building. Exceptional problem-solving skills, with the ability to balance technical and business priorities effectively. Experience in budget management, vendor negotiations, and resource allocation. Preferred Skills: Knowledge on TM Forum APIs, GenAI and their application in telecom/enterprise environments. Knowledge of emerging technologies and trends in the IT and telecom sectors. Experience in fostering partnerships with business leaders and external vendors. Exposure to SaaS solutions like ServiceNow, Workday, Oracle Financials Weekly Hours: 40 Time Type: Regular Location: IND:AP:Hyderabad / Argus Bldg 4f & 5f, Sattva, Knowledge City- Adm: Argus Building, Sattva, Knowledge City It is the policy of AT&T to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, AT&T will provide reasonable accommodations for qualified individuals with disabilities. AT&T is a fair chance employer and does not initiate a background check until an offer is made. Show more Show less

SUMMARY SAR & SAR-like Patient Safety Physician Job Description Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborating with Therapeutic Head to identify signals and address product safety concerns Engaging with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensuring 100% compliance with timely completion of all client and Cognizant required trainings Achieving 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Competencies Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Experience Relevant educational background and experience in patient safety or related field Required Skills Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities

Job Description: Key Responsibilities: Provide 24/7 support for production systems and applications, ensuring their optimal performance and availability. Monitor system performance and respond to incidents promptly, following established procedures for resolution. Perform routine maintenance tasks, including backups, patching, and updates. Collaborate with senior team members to deploy new releases and updates, ensuring minimal disruption. Troubleshoot and resolve issues related to application performance, database connectivity, and server configurations. Document support activities, incidents, and resolutions in the ticketing system. Participate in shift rotations, ensuring continuous support coverage. Implement and maintain automation scripts for routine tasks using Python Scripting and Shell Scripting. Administer and support web applications developed using JavaScript and Node/NPM. Shift: Rotational Shifts (24/7 Support) Technical Skills: Programming : Java, JavaScript, Node/NPM, Python Scripting, Shell Scripting Operation Experience : Admin/support, HA Proxy, Productions operations, webapp development Database : MySQL, PostgreSQL, Oracle DevOps Tools : DevOps, Jenkins, Docker, Kubernetes, Terraform, NGINX, JFrog, Chef, Productions operations Operating Systems : Linux/Unix Cloud Experience : Experience with cloud platforms (Azure, AWS, GCP) is an advantage Qualifications: Bachelor's degree in Computer Science, Information Technology, or a related field. 2-4 years of experience in operations support, system administration, or a similar role. Familiarity with DevOps principles and practices. Basic knowledge of database management and administration (MySQL, PostgreSQL, Oracle). Proficiency in programming and scripting languages (Java, JavaScript, Python, Shell). Hands-on experience with cloud platforms (Azure, AWS, GCP) is a plus. Familiarity with CI/CD tools (Jenkins) and containerization technologies (Docker, Kubernetes) is an advantage. Strong problem-solving skills and the ability to work under pressure. Good communication and teamwork skills. Willingness to work in a rotational shift environment, including nights and weekends. Preferred Qualifications: Experience with web application development and support. Basic knowledge of production operations best practices. Previous experience in a 24/7 support environment. Benefits: Competitive salary and benefits package. Opportunities for professional development and growth. Collaborative and inclusive work environment. Health and wellness programs. #SoftwareEngineering Weekly Hours: 40 Time Type: Regular Location: IND:AP:Hyderabad / Argus Bldg 4f & 5f, Sattva, Knowledge City- Adm: Argus Building, Sattva, Knowledge City It is the policy of AT&T to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, AT&T will provide reasonable accommodations for qualified individuals with disabilities. AT&T is a fair chance employer and does not initiate a background check until an offer is made.

Job Title: Quality & Compliance Manager - Global Business Services Career Level - D Introduction to role AstraZeneca (AZ) has a bold aspiration to improve the lives of 200 million patients by delivering 20 new medicines by 2030. This role is critical in contributing to AZ’s long-term ambition. Global Business Services (GBS) is growing to support critical functions across the whole enterprise. This role will be specifically focused on defining and delivering GBS opportunities within the R&D areas of the business. GBS is enhancing its customer focus by establishing Research & Development (R&D) Services to improve alignment and strengthen our relationships with SET areas. R&D Services is a key element of the GBS Bold Ambition, driving our vision to enable AstraZeneca to change and grow at speed. Between now and 2030, 10 new R&D capabilities are to be established, ensuring that GBS can offer the broad range of services required to support AZ ambitions. As the Patient Safety Quality Manager, you will be responsible for developing and maintaining excellence in global PV Quality, Compliance, Audit and Inspection management, Process Improvement, and Data Governance. You will ensure oversight of the PV Quality Management System, maintain inspection readiness, and ensure compliance with worldwide pharmacovigilance regulations. Collaborating with key PV and non-PV stakeholders across AstraZeneca, you will align with company-wide standards, oversee compliance and quality of PV processes, conduct internal audits and deviation investigations, analyse and report on key metrics, and support the client’s continuous improvement plans to establish best-in-class PV practices. This role is crucial in ensuring the timely and accurate quality and compliance from our Bangalore hub, contributing to AZ’s overall global pharmacovigilance efforts and ultimately supporting patient safety worldwide. Accountabilities Oversee the daily operations of Quality and Compliance within the Bangalore hub, supporting the efficient processing and reporting of adverse event cases within regulatory timelines Lead and manage the Quality and Compliance Advisors, ensuring appropriate guidance, training, and performance management to maintain high-quality standards Implement and maintain standardised operating procedures (SOPs) for case intake and processing, ensuring consistency with global pharmacovigilance practices Collaborate with other GBS Patient Safety Hub Managers and Directors and the Global Patient Safety (GPS) team to improve processes and share standard methodologies Control the tools to monitor compliance, quality metrics, and key performance indicators (KPIs) for global PV processes, license partners, and vendors. Ensure feedback and trend analysis to support AstraZeneca continuous improvement. Lead internal assessments, support external audits and regulatory inspections, and implement standard processes for audit and inspection management in collaboration with the client’s Quality Assurance teams. Oversee Corrective & Preventive Actions and deviation processes, provide support and guidance on development and implementation, track progress, collect evidence, and coordinate effectiveness checks. Support a drive in continuous process improvements by analysing audit/inspection findings, identifying quality risks, and leading initiatives to enhance PV compliance and operational efficiency. Develop and maintain internal training programs related to audit/inspection readiness, compliance, and quality performance indicators, ensuring alignment across global PV teams and affiliates. Support data governance initiatives to ensure high-quality data for decision-making, assess downstream implications of data activities, and align ongoing initiatives with compliance requirements. Ensure compliance with global regulatory requirements, including timely submission of appropriate Regulatory Reports to relevant authorities Serve as a subject matter expert during audits and inspections related to case intake processes within the hub Contribute to the development and optimisation global patient safety processes, systems and tools, including automation solutions Stay updated on regional and global pharmacovigilance regulations for those MCs supported by the hub, ensuring that necessary changes are implemented to maintain compliance Maintain appropriate staffing levels in the hub, being responsible for recruitment of new staff where required. Ensure that training and development of GBS PS staff results in consistent and compliant knowledge and skills within the hub. Essential Skills/Experience BA or BS degree or equivalent Extensive experience in the pharmaceutical, biotechnology, or related industry. Strong background in Pharmacovigilance, Regulatory Affairs, or Safety Quality Assurance, with expertise in establishing safety quality system standards that impact multiple departments and management levels. Proven experience in people or project management within a highly matrixed, multicultural global setting, demonstrating facilitation, negotiation, problem-solving, and conflict resolution skills. Deep knowledge of global safety regulations for both marketed and investigational products, along with expertise in process management, standards, training, and IT functions across the pharmaceutical product life cycle. Solid understanding of PV and Clinical Research processes, including their interfaces and contributions to the overall PV system. Expertise in Pharmacovigilance, data management, and adverse event reporting and processing, with proficiency in relevant software tools Exceptional attention to detail and commitment to maintaining high-quality standards in case processing and reporting Ability to work in a fast-paced environment, manage multiple priorities, and meet tight deadlines Strong analytical and problem-solving skills, Excellent communication skills, both written and verbal, with the ability to interact effectively with internal and external stakeholders across different regions Ability to work in a team environment / works collaboratively Desirable Skills/Experience Knowledge of global and regional pharmacovigilance regulations Track record in managing and optimising Patient Safety processes Proficiency in safety databases, ideally Argus, and case management systems When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca is a place where technology meets science to create life-changing medicines. We empower our teams to innovate using cutting-edge technology platforms combined with data analytics. Our collaborative environment fosters creativity as we work together to push boundaries. With significant investment behind us, we are driving cross-company change that disrupts the industry. Ready to make an impact? Apply now! Show more Show less

About Client: Our client brings together Pharmacovigilance expertise, third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across Medical Affairs, Regulatory and Safety functions. Our client solutions free up responsible personnel within Pharma companies to execute their stated responsibilities while staying true to the laws of the land, and ultimately achieving a balance between compliance and managing business risks. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable them to serve large and small organizations, both in developed and emerging markets. ​ Our client is committed to bringing focus to things that really matter for advancing patient outcomes. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable us to serve large and small organizations, both in developed and emerging markets. Position Overview: Position: Argus Configuration Specialist Location: Remote (Tokyo, Japan) Experience: 15+ years • Should have good understanding of the Pharmacovigilance/ Health Care domain. • Should have excellent knowledge of Oracle Argus Safety or other PV/Safety systems. • Should have experience in installing/configuration/validation of Argus Safety and customizations. • Should have good knowledge of SQL, PL/SQL. • Should have experience in configuring reports in Argus Aggregate and Periodic reports. • Should have experience in Regulatory Standards like 21 CFR Part 11, ICH, GxP. • Should have experience in Argus Business and system configuration. • Should be able to provide technical architecture and design as per the user requirements. • Should have experience in performing System Integration and User Acceptance testing as part of upgrade/ implementation projects. • Should have good understanding of regulations (EU, FDA, MFDS, NMPS, Mexico, Taiwan and Russia). Show more Show less

Main Responsibilities Manage the PV Configuration Standards, Distribution Rules, Study Configurations in LSMV, LSR & EV triage module Perform User Accept Testing for Configuration Changes on behalf of the PV Systems Business Team Work with Business Users to understand the Configuration changes and document them Participate in updating training materials as releases move through the development and deployment process. Facilitate support and training sessions for system users Support Safety Team during Audits & Inspections for providing Safety Data and Ad-hoc reports on urgency basis Analyze the impact of changes to the system not just limited to Upgrades, Config Changes, Introduction of new features, and any other potential changes to the PV System Implement relevant action items to mitigate any potential issues arising based on the Impact Analysis Responsible for PV System Configurations of PV database- Company Products, Clinical & Post marketed Studies Business user Roles & Data Privacy Code Lists, Libraries, MedDRA, WHO Distribution Rules Accounts & HA Destinations E2B Profiles SDEA profiles & gateway Manage E2B gateway with Health authorities & Business Partners Implement Data Migration & Ingestion requests Actively participate and contribute to the growing needs of Drug Safety PV Regulations Support digital vendor teams in Configuration Changes needs, Testing & Deployments Work with Business Users to understand the Configuration change needs and document them Work in an Agile environment Experience About you Experience in PV Databases like ARGUS, Aris-G, VAULT Safety, LSMV etc. Experience in a systems operations support role within safety/pharmacovigilance as configuration analyst, configuration manager Hands-on in Case Processing to support the Business User for troubleshooting and problem solving Experience in configuration of Products, INNs, Salts and their variations, MedDRA Events Hands-on experience in dealing with Local Affiliates and understanding their Regulatory needs Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation Knowledge of IT systems in the pharmaceutical industry with an emphasis on PV systems Knowledge of validation processes Good knowledge of SQL, PL/SQL and MS Office Minimum 5 years of pharmaceutical industry experience with a focus on pharmacovigilance Strong experience in Computer System Validation is required Incumbent should have hands-on in Process Improvement practices Soft Skills Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Excellent team-work and interpersonal skills Ability to work in cross-functional teams Excellent oral and written communication skills Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Technical Skills Regulatory Standards, Good Pharmacovigilance Practices (GxP), PV Configurations, Safety risk management, Safety Reporting Requirements. Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data. Software Testing/Validation: Knowledge of user acceptance testing (UAT) for pharmacovigilance software and familiarity with data migration processes during system upgrades Good depth understanding of Quality Risk Management and Quality systems Education Bachelor’s degree in pharmacy / Life Sciences / Engineering or equivalent Academic qualification is desirable with 5 years’ Technical Experience in GxP systems preferably in PV databases Languages : Fluent in English (verbal and written) Show more Show less

Job Description: Azure Infra Support Engineer We are seeking a seasoned Azure Infrastructure Support Engineer to join our team, dedicated to maintaining, patching, and optimizing Azure infrastructure to comply with defined process, security best practices. The ideal candidate will possess extensive experience with Virtualization, Storage, Security and Networking. Candidate should have good experience with Linux for troubleshooting and automation use cases. Responsibilities: Maintain, patch, and optimize existing infrastructure, including servers (VM, VMSS), Storage (Storage Accounts, Managed Disks), and network configs (NSGs, ASGs), ensuring High Availability & performance. Utilize tools such as Terraform to provision, deploy, and manage infrastructure across development, testing, UAT and production environments. Periodic OS patching using Golden Images & certificate renewals. Monitor, troubleshoot, and optimize infrastructure for performance and scalability, employing best practices for system health and security. Develop and maintain comprehensive documentation related to infrastructure processes, tools, and configurations. Conduct system audits, including security and performance reviews, to ensure compliance with industry standards and best practices. Stay updated with the latest in infrastructure technologies and methodologies, continuously seeking to improve our processes and tools. Participate in on-call rotations to provide support for critical production issues and perform scheduled maintenance tasks outside of peak hours as necessary. Ensure security compliance by remediating identified vulnerabilities. Continuous improvement by employing cost/wastage reduction measures. Qualifications: Bachelor’s degree in computer science, IT, Computer applications, Engineering, or a related field, or equivalent professional experience. Required Skills: Solid experience as an Infrastructure Engineer or in a similar role, with a proven track record of deploying, maintaining, and upgrading scalable and reliable infrastructure. Working experience with VM & VMSS), Storage (Storage Accounts, Disks), Key Vaults, Entra-ID RBAC etc. Proven expertise in planned/scheduled patching activities within defined SLAs. Proficiency in Linux (Ubuntu/RHEL/CentOS) usage and system admin tasks. Experience managing enterprise-grade infrastructure on the Azure Cloud. Knowledge of security fixes, key rotation, vulnerability remediation & certificate renewals. Experience with version control systems, such as Git. Excellent problem-solving skills and the ability to work independently or as part of a team. Strong communication and collaboration skills, capable of working effectively across multiple teams. AMA Migration and troubleshooting. Perform Server reboots, application issue fixes and file system issue fixes with final RCA. Desired Skills Azure Administrator Associate certification (AZ-104) Familiarity with monitoring and logging tools (e.g., Prometheus/Grafana/ELK/Azure Monitor) Weekly Hours: 40 Time Type: Regular Location: IND:AP:Hyderabad / Argus Bldg 4f & 5f, Sattva, Knowledge City- Adm: Argus Building, Sattva, Knowledge City It is the policy of AT&T to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, AT&T will provide reasonable accommodations for qualified individuals with disabilities. AT&T is a fair chance employer and does not initiate a background check until an offer is made. Show more Show less

Job Description: Key Responsibilities: Provide 24/7 support for production systems and applications, ensuring their optimal performance and availability. Monitor system performance and respond to incidents promptly, following established procedures for resolution. Perform routine maintenance tasks, including backups, patching, and updates. Collaborate with senior team members to deploy new releases and updates, ensuring minimal disruption. Troubleshoot and resolve issues related to application performance, database connectivity, and server configurations. Document support activities, incidents, and resolutions in the ticketing system. Participate in shift rotations, ensuring continuous support coverage. Implement and maintain automation scripts for routine tasks using Python Scripting and Shell Scripting. Administer and support web applications developed using JavaScript and Node/NPM. Shift: Rotational Shifts (24/7 Support) Technical Skills: Programming : Java, JavaScript, Node/NPM, Python Scripting, Shell Scripting Operation Experience : Admin/support, HA Proxy, Productions operations, webapp development Database : MySQL, PostgreSQL, Oracle DevOps Tools : DevOps, Jenkins, Docker, Kubernetes, Terraform, NGINX, JFrog, Chef, Productions operations Operating Systems : Linux/Unix Cloud Experience : Experience with cloud platforms (Azure, AWS, GCP) is an advantage Qualifications: Bachelor's degree in Computer Science, Information Technology, or a related field. 2-4 years of experience in operations support, system administration, or a similar role. Familiarity with DevOps principles and practices. Basic knowledge of database management and administration (MySQL, PostgreSQL, Oracle). Proficiency in programming and scripting languages (Java, JavaScript, Python, Shell). Hands-on experience with cloud platforms (Azure, AWS, GCP) is a plus. Familiarity with CI/CD tools (Jenkins) and containerization technologies (Docker, Kubernetes) is an advantage. Strong problem-solving skills and the ability to work under pressure. Good communication and teamwork skills. Willingness to work in a rotational shift environment, including nights and weekends. Preferred Qualifications: Experience with web application development and support. Basic knowledge of production operations best practices. Previous experience in a 24/7 support environment. Benefits: Competitive salary and benefits package. Opportunities for professional development and growth. Collaborative and inclusive work environment. Health and wellness programs. #SoftwareEngineering Weekly Hours: 40 Time Type: Regular Location: IND:AP:Hyderabad / Argus Bldg 4f & 5f, Sattva, Knowledge City- Adm: Argus Building, Sattva, Knowledge City It is the policy of AT&T to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, AT&T will provide reasonable accommodations for qualified individuals with disabilities. AT&T is a fair chance employer and does not initiate a background check until an offer is made. Show more Show less

Job description Bangalore, India Job category Reg Affairs & Safety Pharmacovigilance Department Global Safety - Global Business Services (GS-GBS). Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position for you. Apply now and join a growing team, working in an international environment. The Position As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the labelling for marketed products. Furthermore, perform ongoing and systematic surveillance of Novo Nordisk (NN) products during pre-approval and post-approval phases based on safety information from worldwide sources and communication of drug safety issues internally and to health authorities (HAs), as required. You will be required to establish, operate and chair the NN cross-functional safety committee throughout the lifecycle of the actual product present analysis and results of the ongoing safety surveillance at pre-defined intervals in order for the safety committee to make endorsements/recommendations. You will be responsible for all areas related to patient safety in clinical trials. You are entrusted to fulfil the following responsibilities Act as Ownerof the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for developments products. Maintenance of labelling for marketed products and participate as labelling change request (LCR) reviewer and provide safety input as LCR reviewer. As author you will prepare relevant sections of Development Safety Update Reports (DSURs), periodic Serious Unexpected Suspected Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs) and clinical Risk Management Plans (RMPs) according to implementation plans or as required by Health Authorities (HAs). Respond to requests from HAs and internally from NN affiliates. Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator s Brochure (IB), integrated safety summaries, abstracts and planned publications. You will provide proactive safety communication by participation in project/trial groups/teams established, as appropriate and conduct Investigator training as required. Provide answers to enquiries from HAs and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/ Informed Consent (ICs), establish and ensure deliverables to/from Data Monitoring Committees (DMCs). Qualifications Masters in Medicine/MD post MBBS graduate is Preferred. Relevant Experience in Signal Management, Aggregate Management, ICSR. Comfortable user of Microsoft office package (Outlook, Word, Excel, and PowerPoint). Fluent in written and spoken English. Analytical mind-set. Professional authority. Quality mind-set, well-organised and strive for excellence. Pro-active planner to meet agreed deliverables. Strong communicator (verbally and in writing). Curious and constantly looking for improvement opportunities. Team player with high degree of flexibility and service mindedness. Cross-cultural awareness. Ability and willingness to quickly adjust to changes in a continuously developing environment.

A career within Financial Markets Business Advisory services, will provide you with the opportunity to contribute to a variety of audit, regulatory, valuation, and financial analyses services to design solutions that address our clients’ complex accounting and financial reporting challenges, as well as their broader business issues. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be a purpose-led and values-driven leader at every level. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. Responsibilities As a Senior Associate, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Use feedback and reflection to develop self awareness, personal strengths and address development areas. Delegate to others to provide stretch opportunities, coaching them to deliver results. Demonstrate critical thinking and the ability to bring order to unstructured problems. Use a broad range of tools and techniques to extract insights from current industry or sector trends. Review your work and that of others for quality, accuracy and relevance. Know how and when to use tools available for a given situation and can explain the reasons for this choice. Seek and embrace opportunities which give exposure to different situations, environments and perspectives. Use straightforward communication, in a structured way, when influencing and connecting with others. Able to read situations and modify behavior to build quality relationships. Uphold the firm's code of ethics and business conduct. Job Description Main purpose of the job and key background information (Note: Key responsibilities are assigned based on an evaluation of the candidate’s professional qualification, relevant experience, Excel skills, and a demonstrated working knowledge of financial analysis that impacts the business and economic environment.) Job Overview The Real Estate Corporate Finance practice assists institutional and private clients achieve a broad set of objectives including acquisitions/dispositions, mergers, capital raises, public-to-privates, equity release structures, sale leasebacks, and platform sales of real estate fee businesses across core and alternative asset sectors. Key Responsibilities Create, maintain, and analyze basic and advanced real estate valuation models including DCFs, LBOs, etc. Create, maintain and analyze generic and specific company, industry and market overviews. Prepare decision making documents and analyses i.e. pitch books, discussion documents, information memorandums, etc. Support Due Diligence processes across various real estate asset types Work closely with the Business Development team to identify potential opportunities Requirements These should include essential & desirable requirements such as: Level of experience Education/qualifications Industry experience Technical capability Sales/BD capability Metrics Key personal attributes Consulting experience Knowledge of real estate valuations, real estate appraisals, and real estate listed companies valuation metrics and drivers 0 to 5 years of experience Understand innovative investment structures and funding mechanisms to suit both the real estate developers and investors Should possess excellent writing and financial modeling skills. Hands on in making Pitch books, Information Memorandums, Financial Projections. Hands on knowledge of Argus Enterprise Show more Show less