1722 Pharmacovigilance Jobs - Page 3

**Job Description:** As a CSV Lead in the Drug Safety domain, you will be responsible for overseeing the validation process of safety systems, including but not limited, or other drug safety databases. You will lead cross-functional teams and manage CSV lifecycle activities, including planning, executing, and documenting validation efforts for drug safety systems. **Key Responsibilities:** - Lead validation efforts for drug safety systems such other similar platforms, ensuring compliance with industry standards (21 CFR Part 11, GxP, and other relevant regulations). - Develop, review, and approve validation documentation, including Validation Plans, Protocols, Reports, and Traceability Matrices. - Perform risk assessments and impact analysis of software changes or upgrades to ensure compliance with validation requirements. - Collaborate with cross-functional teams (IT, Quality Assurance, Pharmacovigilance, and Compliance) to ensure effective implementation and maintenance of validated systems. - Provide guidance and training on validation processes and regulatory requirements. - Support audits and inspections related to CSV activities and respond to findings or inquiries from regulatory bodies. - Manage the CSV lifecycle, including requirements gathering, testing, and system releases for safety systems. - Ensure that all system-related issues are identified, tracked, and resolved in a timely manner. **Qualifications:** - Bachelor's degree in Computer Science, Life Sciences, or a related field (or equivalent experience). - Minimum of 2years of experience in Computer System Validation, with a focus on drug safety systems (Argus, ArisG, or similar). - In-depth knowledge of pharmaceutical and regulatory requirements, including 21 CFR Part 11, GxP, and ICH guidelines. - Strong experience in system validation and lifecycle management of computer systems, including testing, documentation, and quality assurance processes. - Familiarity with the pharmacovigilance domain and the processes for adverse event reporting and management. - Excellent communication and leadership skills with the ability to work in cross-functional teams. - Experience with audit readiness and regulatory inspections (FDA, EMA, etc.) is a plus. - Certification in Computer System Validation or related fields is a plus.

Responsible for Pharmacy Sales, Purchase, Inventory & Team Management Oversee the overall operations of the pharmacy, ensuring safe and efficient dispensing of medications. Supervise and manage pharmacy staff, including pharmacists, technicians, and support staff. Ensure compliance with all regulatory requirements (e.g., FDA, CDSCO, local drug control authorities). Monitor inventory levels, place purchase orders, and manage stock to avoid shortages or expiries. Implement and monitor SOPs for drug storage, dispensing, labeling, and documentation. Maintain accurate records of prescriptions, controlled substances, and billing. Provide guidance on drug usage, interactions, and dosages to patients and healthcare providers. Train and mentor new team members, ensuring adherence to safety and quality standards. Coordinate with doctors, nurses, and other departments for smooth operations. Address customer or patient complaints professionally and promptly.

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Any Graduation Years of Experience: 1 to 3 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? 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 world’s 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. The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components. Coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for? sBachelor Degree in Life Sciences Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts

Company Description Sarjen Systems has been a trusted digital transformation and automation partner for more than 25 years, providing an array of software solutions spanning Drug Development to Sales. Serving industries such as Pharmaceutical, Life Science, Healthcare, and FMCG, Sarjen Systems offers specialized products like PvEdge for pharmacovigilance, BizNET for clinical trial management, QEdge for quality management, FForce for sales automation, and more. The company also provides consultation services in Microsoft technologies, Hyperautomation, SAP, eCTD, and publishing. Located in Ahmedabad, Sarjen Systems invites prospective candidates to join its innovative team. Role Description This is a full-time, on-site role for a SAP ABAP Developer, based in Ahmedabad. The SAP ABAP Developer will be responsible for coding, testing, and implementing solutions using ABAP programming language. Daily tasks include developing and maintaining SAP applications, writing technical specifications, conducting technical unit tests, interacting with functional teams to understand requirements, and providing support for SAP modules. The role requires collaborating closely with cross-functional teams to ensure the aligned development of business solutions. Qualifications Proficiency in SAP ABAP programming, including ABAP Workbench Experience with data dictionary, reports, module pool, BADI, BAPI, user exits, and enhancements Familiarity with SAP modules like MM, SD, FI, and CO Strong problem-solving skills and attention to detail Excellent communication and collaboration skills Ability to work within deadlines and independently Knowledge of software development life cycle and SAP best practices Bachelor’s degree in Computer Science, Information Technology, or a related field Experience in pharmaceutical or life sciences industry is a plus

Summary Location: Hyderabad In this role, he will drive a strategic AI transformation across the pharmaceutical value chain, from drug discovery to commercialization, by leading enterprise-wide initiatives and coaching sub-ordinates to deliver high-impact solutions. About The Role Major Accountabilities Domain Expertise: Serve as a strategic expert in life sciences, providing leadership in applying Generative AI to drug discovery, clinical trials, regulatory affairs, pharmacovigilance, and market access. Drive thought leadership by identifying and promoting innovative Generative AI applications to position the organization as an industry leader. Business Analysis: Lead enterprise-wide initiatives to gather, analyze, and prioritize business requirements, aligning AI solutions with long-term organizational objectives. Oversee comprehensive analyses of complex business processes, designing AI-driven strategies to achieve operational excellence and competitive advantage. Authorize and review business cases, feasibility studies, and ROI analyses to secure executive approval for transformative AI initiatives. Ensure the creation of high-quality business requirements documents, process flows, and strategic roadmaps to guide enterprise-level AI implementations. Stakeholder Engagement: Act as a key liaison between C-suite executives, technical teams, and external partners, driving alignment on AI strategies and initiatives. Lead enterprise-level workshops, steering committees, and governance boards to shape AI adoption and ensure stakeholder buy-in. Represent the organization in industry forums and partnerships to advocate for AI-driven innovation in life sciences. Team Management and Coaching: Manage/mentor a team of Senior Specialist Business Analysts, providing strategic guidance, setting performance goals, and fostering professional development to ensure high-impact AI business use case delivery. Coach Senior Specialists in advanced business analysis techniques and Generative AI applications, enhancing their ability to address complex challenges in the life sciences domain and ensuring alignment with organizational objectives. Generative AI: Oversee the development and deployment of enterprise-scale Generative AI solutions, ensuring alignment with business needs and technical feasibility.s Collaborate with AI architects and data science leaders to define model architectures and deployment frameworks for life sciences applications. Ensure AI solutions are scalable, reliable, and fully integrated into mission-critical workflows. Regulatory & Compliance: Establish governance frameworks to ensure AI solutions comply with global regulatory standards (e.g., USFDA, EU, PMDA) and ethical principles. Lead risk management efforts, addressing ethical, legal, and operational risks associated with AI deployment in life sciences. Minimum Requirements 10–12 years of core Business Analyst or strategic consulting experience in the life sciences domain with at least 5 years leading AI technologies, supported by a Master’s degree in Life Sciences, Biomedical Sciences, Computer Science, Data Science, or a related field. A PhD or MBA is highly desirable. Expert understanding of Generative AI, machine learning, and their applications in life sciences. Proficiency in advanced data analysis tools (e.g., Python, TensorFlow, Power BI). Exceptional project management skills, with a proven track record of leading enterprise-scale AI projects (e.g., Agile, SAFe, or PMI methodologies). Superior analytical and problem-solving abilities, with a strategic mindset and ability to drive organizational change. Outstanding communication and leadership skills, with the ability to influence C-level stakeholders and lead cross-functional teams. Deep familiarity with life sciences/pharmaceutical regulatory requirements and industry standards. Why consider Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn More Here https://www.novartis.com/about/strategy/people-and-culture Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

As a Pharmacovigilance Services Analyst at Accenture, you will be responsible for providing Pharmacovigilance & Drug Safety Surveillance services. With 2 to 5 years of experience and educational qualifications in Any Graduation/Bachelor of Pharmacy/Master of Pharmacy, you will play a key role in the management of the Affiliate Mailbox, reconciliation of reports, and performing follow-up attempts for both Serious and Non-serious cases. Your responsibilities will include case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and global regulatory requirements. In this position, you are expected to possess agility for quick learning, work effectively in a team setting, and demonstrate a strong commitment to quality. Proficiency in Japanese at an elementary level (JLPT N3 to N5) will be an added advantage. Your role will involve analyzing and solving lower-complexity problems, interacting with peers within Accenture, and receiving instructions on daily tasks from supervisors. While your decision-making will impact your work and potentially that of others, you will primarily focus on individual contributions within a team environment. Please be aware that this role may involve working in rotational shifts. Accenture, a global professional services company, offers expertise in digital, cloud, and security services across various industries. Within the Life Sciences R&D vertical, our services encompass research support, clinical trials, regulatory services, pharmacovigilance, and patient solutions. By joining the Clinical, Pharmacovigilance & Regulatory sub-offering, you will contribute to assisting leading biopharma companies in realizing their vision and enhancing outcomes through patient-centric approaches. Your role will be crucial in facilitating the convergence of scientific expertise with insights into the patient experience. To learn more about Accenture and our services, please visit www.accenture.com.,

Company Description We're Nagarro. We are a Digital Product Engineering company that is scaling in a big way! We build products, services, and experiences that inspire, excite, and delight. We work at scale across all devices and digital mediums, and our people exist everywhere in the world (18,000 experts across 38 countries, to be exact). Our work culture is dynamic and nonhierarchical. We are looking for great new colleagues. That is where you come in! Job Description REQUIREMENTS: Total Experience – 1+yrs Strong experience in data analysis, reporting, or business intelligence Extensive experience in developing pharmacovigilance reports (e.g., ICSR metrics, compliance reports) Proficiency in Power BI and/or IBM Cognos for report and dashboard development Solid understanding of SQL, Excel, and data visualization best practices Experience collaborating with cross-functional teams to define and deliver reporting requirements Familiarity with data quality assessment and report automation techniques Strong attention to detail, problem-solving mindset, and effective communication skill RESPONSIBILITIES: Design, build, and maintain pharmacovigilance reports and dashboards in compliance with industry standards Collaborate with safety and data teams to translate reporting needs into actionable insights Validate report outputs and ensure data accuracy, completeness, and compliance Perform data integrity checks and contribute to the automation of recurring reports Stay updated with pharmacovigilance trends, tools, and reporting framework Qualifications Bachelor’s or master’s degree in computer science, Information Technology, or a related field.

The Manager, Global PV System Operations at Kenvue is a key role reporting to the Associate Director, Global PV System Operations (GPSO) and is based in India. As a Kenvue employee, you will be part of a global team dedicated to delivering the best products to customers and impacting the lives of millions of people every day. With a focus on science, care, empathy, and trust, Kenvue offers brilliant opportunities for individuals passionate about insights and innovation. In this role, you will be responsible for supporting the Director, GPSO in maintaining Pharmacovigilance (PV) System Operations. This includes partnering with internal and vendor Information Technology teams, as well as Safety Science and Analytics (SSA) on implementing new systems, maintaining existing systems, and providing user support for vendor-supported systems. Your key responsibilities will involve overseeing vendor staff, managing system activities, assisting in the implementation of new PV systems and upgrades, and ensuring compliance with regulatory requirements. You will also play a crucial role in liaising with various functions to facilitate timely case processing and reporting activities, managing staff aligned with strategic goals, leading CAPA management, participating in audits and inspections, and developing Standard Operating Procedures (SOPs)/Work Instructions (WIs) related to safety information reporting. The ideal candidate will have a BA or BSc degree in a health-related field, broad knowledge of pharmacovigilance, industry experience in consumer safety, and project management skills. Desired qualifications include experience in leading global projects and thriving in a matrix environment. Kenvue offers a competitive Total Rewards Package, learning and development opportunities, and a supportive work environment. Join us at Kenvue and be part of shaping the future while advancing your career in Drug & Product Safety Science.,

Skill required: Pharmacovigilance Services - Medical Affairs Designation: Pharmacovigilance Services Specialist Qualifications: MBBS Years of Experience: 0 to 1 year 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? 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 world’s 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. Design, develop and deliver business solutions related to the medical affairs group of pharmaceutical companies, including thought leadership development, medical publications, education and information, medical grants, advisory boards and advocacy. What are we looking for? Ability to work well in a team Adaptable and flexible Agility for quick learning Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts

Career Category Information Systems Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let s do this. Let s change the world. In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will analyze and resolve issues with adverse event data and file transmissions across integrated systems, leveraging data analytics to identify trends, optimize workflows, and prevent future incidents. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient data flow critical to safety operations. Monitor, solve, and resolve issues related to adverse event data processing across the safety ecosystem. Triage and conduct detailed investigations into system disruptions, data anomalies, or processing delays to determine and nature and scope of the problem Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues and triage the issues and provide L1/L2 support Identify inefficiencies and propose data-driven solutions to optimize and enhance reliability. Present findings and recommendations to leadership, ensuring data-driven decision-making and clear transparency into system operations. Support compliance with Key Control Indicators (KCI) and chips in to overall process governance What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Bachelor s degree and 2 to 6 years of Life Science / Biotechnology / Pharmacology / Information Systems experience Demonstrated expertise in monitoring, troubleshooting, and resolving data and system issues. Good understanding of Pharmacovigilance process and knowledge on safety systems like (Argus, Arisg, LSMV etc. ) Basic familiarity with ITSM tools like Service now or JIRA Identify and escalate potential safety/compliance issues. Familiarity with database technologies and querying tools, including SQL (Oracle SQL, PL/SQL preferred). Experience with testing methodologies, tools, and automation practices. Familiarity with regulatory compliance testing (e. g. , FDA 21 CFR Part 11, GAMP Experienced in Agile methodology Preferred Qualifications: Understanding of API integrations and middleware platforms (e. g. , MuleSoft). Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Sharp learning agility, problem solving and analytical thinking Experienced in GxP systems and implementing GxP projects Experience in SDLC, including requirements, design, testing, data analysis, change control Certification: SAFe for Teams certification (preferred) Soft Skills: Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Ability to deal with ambiguity and think on their feet Shift Information: This position requires you to work a later shift and will be assigned third shift schedule (Overnight shift on a rotational basis). Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. .

Career Category Information Systems Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let s do this. Let s change the world. In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will analyze and resolve issues with adverse event data and file transmissions across integrated systems, leveraging data analytics to identify trends, optimize workflows, and prevent future incidents. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient data flow critical to safety operations. Monitor, solve, and resolve issues related to adverse event data processing across the safety ecosystem. Triage and conduct detailed investigations into system disruptions, data anomalies, or processing delays to determine and nature and scope of the problem Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues and triage the issues and provide L1/L2 support Identify inefficiencies and propose data-driven solutions to optimize and enhance reliability. Present findings and recommendations to leadership, ensuring data-driven decision-making and clear transparency into system operations. Support compliance with Key Control Indicators (KCI) and chips in to overall process governance What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Bachelor s degree and 2 to 6 years of Life Science / Biotechnology / Pharmacology / Information Systems experience Demonstrated expertise in monitoring, troubleshooting, and resolving data and system issues. Good understanding of Pharmacovigilance process and knowledge on safety systems like (Argus, Arisg, LSMV etc. ) Basic familiarity with ITSM tools like Service now or JIRA Identify and escalate potential safety/compliance issues. Familiarity with database technologies and querying tools, including SQL (Oracle SQL, PL/SQL preferred). Experience with testing methodologies, tools, and automation practices. Familiarity with regulatory compliance testing (e. g. , FDA 21 CFR Part 11, GAMP Experienced in Agile methodology Preferred Qualifications: Understanding of API integrations and middleware platforms (e. g. , MuleSoft). Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Sharp learning agility, problem solving and analytical thinking Experienced in GxP systems and implementing GxP projects Experience in SDLC, including requirements, design, testing, data analysis, change control Certification: SAFe for Teams certification (preferred) Soft Skills: Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Ability to deal with ambiguity and think on their feet Shift Information: This position requires you to work a later shift and will be assigned third shift schedule (Overnight shift on a rotational basis). Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. .

Career Category Engineering Job Description As a Sr Associate IS Engineer, you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will engage with business users and functional SMEs, driving the delivery of innovative technology solutions that enhance business outcomes. Areas of focus will be on leading team performance, delivery management, and facilitating continuous improvement in both technical skills and user experience. Roles & Responsibilities: Work with partners to identify and prioritize system enhancements and new functionalities to meet evolving business needs Lead the day-to-day operations and maintenance of Pharmacovigilance (PV) systems. Overall accountability of technical implementation aspects of projects including planning, architecture, design, development, and testing to follow IS Change Control and GxP validation process. Provide support and consultation to clients or project teams to identify requirements and assist with application configurations and deployments. Monitor operational and performance statistics for managed systems to ensure reliability and availability. Oversee production change control schedule and participates in change control processes. Stay updated on industry trends, emerging trends and standard processes for PV systems. Maintain knowledge of trends in application development frameworks and related new technologies to provide, recommend, and deliver standard methodology solutions. Basic Qualifications and Experience: Master s / Bachelors degree with 5-9 years of experience in Computer Science, Software Development, IT or related field Functional Skills: Must-Have Skills: Experienced in database programming languages, data modelling concepts, including Oracle SQL and PL/SQL. Excellent problem-solving skills. Collaborative spirit and effective communication skills to seamlessly work in a cross-functional team. Hands-on experience with the ITIL framework. Good-to-Have Skills: Experience with API integrations such as MuleSoft, Data Bricks platforms Knowledge of Artificial Intelligence (AI), Robotic Process Automation (RPA), Machine Learning (ML), Natural Language Processing (NLP) and Natural Language Generation (NLG) automation technologies with building business requirements. Experienced in managing GxP systems and implementing GxP projects Extensive experience with Software Development Lifecycle (SDLC). Ability to explain technical concepts to non-technical clients Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Excellent analytical and problem-solving skills Excellent leadership and critical thinking abilities Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Ability to deal with ambiguity and prioritize Ability to influence and drive to an intended outcome Ability to hold team members accountable to commitments Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. .

Career Category Information Systems Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let s do this. Let s change the world. In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will analyze and resolve issues with adverse event data and file transmissions across integrated systems, leveraging data analytics to identify trends, optimize workflows, and prevent future incidents. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient data flow critical to safety operations. Lead triage and resolution of incidents within Safety ecosystem (e. g. , Argus, LSMV, Aris G). Independently resolve recurring and complex L1/L2 issues Perform in-depth troubleshooting and guide resolution of recurring issues. Act as the first point of contact for major incidents or outages. Identify patterns from recurring tickets and initiate corrective actions. Work with platform teams to implement automation, monitoring, and process improvements. Mentor junior support engineers and lead knowledge-sharing sessions. Develop and maintain SOPs, troubleshooting scripts, and process checklists. Present findings and recommendations to leadership, ensuring data-driven decision-making and clear transparency into system operations. Identify inefficiencies and propose data-driven solutions to optimize and enhance reliability. Support compliance with Key Control Indicators (KCI) and chips in to overall process governance What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Masters degree / Bachelors degree and 5 to 9 years of experience in Computer Science, IT or related field Demonstrated expertise in monitoring, troubleshooting, and resolving data and system issues. Hands on experience ITSM tools like Service now or JIRA Good understanding of Pharmacovigilance process and knowledge on safety systems like (Argus, Arisg, LSMV etc. ) Identify and escalate potential safety/compliance issues. Familiarity with database technologies and querying tools, including SQL (Oracle SQL, PL/SQL preferred). Experience with testing methodologies, tools, and automation practices. Experienced in Agile methodology Preferred Qualifications: Understanding of API integrations and middleware platforms (e. g. , MuleSoft). Experience with cloud-based technologies and modern data architectures. Knowledge of automation tools or scripting (e. g. , Python, PowerShell) for diagnostics. Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Sharp learning agility, problem solving and analytical thinking Experienced in GxP systems and implementing GxP projects Experience in SDLC, including requirements, design, testing, data analysis, change control Certification: SAFe for Teams certification (preferred) Soft Skills: Excellent analytical and troubleshooting skills Excellent leadership and strategic thinking abilities Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Ability to deal with ambiguity and think on their feet Shift Information: This position requires you to work a later shift and will be assigned third shift schedule (Overnight shift on a rotational basis). Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. .

Primary Responsibilities: To be an effective participant in Class room training and clear the training assessments with 85% quality Consistently meet the targets set for MOCK charts Eligible employee will get confirmed as Junior Coder within a max of 6 months from the Joining Punctuality, Attendance and General Adherence to company policies, procedures and practices Strives to provide ideas to constantly improve the process Ensure adherence to external and internal quality and security standards (HIPPA/ISO/ISMS) Be an effective team player Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so #NTRQ Eligibility To apply to an internal job, employees must meet the following criteria SG 22 can apply will move laterally Performance rating in the last common review cycle of Meets Expectations or higher Not be on any active CAP (Corrective Action Plan) or active disciplinary action Time in Role Guidelines Should have been in your current position for a minimum of 12 months, if you have not met the recommended minimum time in role, discuss your career interest with your manager and gain alignment prior to applying. And share the alignment email with respective recruiter while applying Required Qualifications: Any degree in Life Science or Bio-Science Any degree in Pharmacy or Pharmaceutical Sciences Any degree in Nursing or Allied Health Any degree in Medicine At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone of every race, gender, sexuality, age, location and income deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes an enterprise priority reflected in our mission. #NJP

Job Summary: We are seeking a dynamic and results-oriented Business Development Manager to drive growth in our Pharmacovigilance services sector, with a special focus on integrating Artificial Intelligence (AI) solutions. The ideal candidate will possess strong knowledge of pharmacovigilance processes, regulatory compliance, and AI-driven innovations, coupled with a proven track record in business development and client relationship management within the life sciences industry. Key Responsibilities: 1. Strategic Growth Development: Identify, evaluate, and pursue new business opportunities in the pharmacovigilance domain, including AI-powered solutions. Develop and implement strategies to expand the company’s market presence and client portfolio. 2. Client Engagement: Build and maintain long-term relationships with pharmaceutical companies, biotech firms, and regulatory agencies. Understand client needs and propose tailored PV and AI solutions. 3. AI Integration in PV Services: Promote AI-driven tools and solutions for adverse event reporting, signal detection, and risk management. Stay updated on emerging AI trends and translate them into business opportunities. 4. Cross-functional Collaboration: Work closely with technical teams, including pharmacovigilance, AI, and data science experts, to develop customized service offerings. Collaborate with marketing to craft compelling proposals, presentations, and campaigns. 5. Market Analysis and Competitive Intelligence: Conduct market research to identify trends, competitive landscape, and emerging needs in PV and AI. Leverage insights to refine business strategies and solutions. 6. Revenue Growth and KPI Achievement: Achieve revenue and sales targets through consistent business development efforts. Monitor and report on sales performance and market dynamics. Qualifications: Educational Background: Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field. Advanced degree (MBA, MPH, or MSc) preferred. Experience: 5+ years of experience in business development within pharmacovigilance, life sciences, or healthcare. Hands-on experience with AI tools or services applied to PV is highly desirable. Skills and Competencies: Deep understanding of pharmacovigilance processes, regulations (e.g., FDA, EMA, ICH guidelines), and compliance standards. Familiarity with AI applications such as natural language processing, machine learning, and automation in pharmacovigilance. Excellent communication, negotiation, and presentation skills. Ability to work in a fast-paced, goal-oriented environment. Preferred Certifications: Certification in pharmacovigilance (e.g., Advanced Pharmacovigilance by DIA) or AI-related courses. What We Offer: Competitive salary and performance-based incentives. Opportunity to work with cutting-edge technologies in PV and AI. A collaborative and inclusive work environment.

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Service Delivery Operations Team Lead Qualifications: MBBS Years of Experience: 7 to 11 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 . Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification MBBS

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 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 Drug saftey associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

About The Role Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Senior Analyst Qualifications: BCom Years of Experience: 5 to 8 years Language - Ability: English(Domestic) - Intermediate 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 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 Ability to handle disputesAbility to meet deadlinesAbility to perform under pressureAbility to work well in a teamAdaptable and flexible Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification BCom

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 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 Drug Safety AssociateDrug Safety Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

We are looking for a highly skilled Medical Content Writer with 3 to 9 years of experience to join our team at Digilantern. The ideal candidate will have a strong background in medical writing and excellent communication skills. Roles and Responsibility Develop high-quality, engaging medical content for various platforms. Conduct research and interviews to gather information and insights. Collaborate with cross-functional teams to ensure consistency and accuracy. Edit and proofread content for clarity, grammar, and punctuation. Stay up-to-date with industry trends and developments. Meet deadlines and deliver content on time. Job Requirements Minimum 3 years of experience in medical writing or a related field. Strong knowledge of medical terminology and concepts. Excellent writing, editing, and communication skills. Ability to work independently and as part of a team. Strong research and analytical skills. Familiarity with content management systems and publishing software.

About The Role Skill required: Operations Support - Pharmacy Benefits Management (PBM) Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Language - Ability: English(International) - Intermediate 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 Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Claims team which is responsible for the administration of health claims. This team is involved in core claim processing such as registering claims, editing & verification, claims evaluation, and examination & litigation.The business processes, operations and interactions of third party administrators of prescription drug programs, understanding of the processes used to manage programs for payers, process and pay prescription drug claims, develop and maintain the formulary, contract with pharmacies and negotiate discounts and rebates with drug manufacturers. What are we looking for Ability to perform under pressureAdaptable and flexibleAbility to establish strong client relationshipWritten and verbal communicationPrioritization of workload 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 Any Graduation

We are looking for a highly skilled and experienced Pharmacist to join our team at MAX Hospital in Noida. The ideal candidate will have 3 to 8 years of experience in the pharmaceutical industry, with a strong background in pharmacy practice. Roles and Responsibility Dispense medications to patients and provide counseling on their proper use. Manage inventory and maintain accurate records of prescriptions and dispensing activities. Collaborate with healthcare professionals to develop and implement medication therapy plans. Conduct patient assessments and monitor their response to medication therapy. Develop and implement pharmacy protocols and procedures. Participate in quality improvement initiatives to enhance patient care and safety. Job Requirements Hold a degree in Pharmacy (D.Pharm, B.Pharm, M.Pharm) from a recognized institution. Possess a minimum of 3 years of experience in pharmacy practice, preferably in a hospital setting. Demonstrate strong knowledge of pharmaceuticals, medications, and medical terminology. Exhibit excellent communication and interpersonal skills. Ability to work effectively in a fast-paced environment and prioritize tasks is essential. Strong analytical and problem-solving skills are required.

About The Role Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Specialist Qualifications: Master Degree in Life Sciences Years of Experience: 7 to 11 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 world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningExperience with Clinical testing - Creation of test scripts for all types of UAT including eCRF UAT, Edit checks UAT, Clinical Data Model UAT and Reports listing UAT and execution of test steps Followed with strong documentation skills and Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification Master Degree in Life Sciences

About The Role Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Sr Analyst Qualifications: Master Degree in Life Sciences Years of Experience: 5 to 8 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 world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningExperience with Clinical testing - Creation of test scripts for all types of UAT including eCRF UAT, Edit checks UAT, Clinical Data Model UAT and Reports listing UAT and execution of test steps Followed with strong documentation skills and Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Master Degree in Life Sciences

About The Role Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Analyst Qualifications: Master Degree in Life Sciences Years of Experience: 3 to 5 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 world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningExperience with Clinical testing - Creation of test scripts for all types of UAT including eCRF UAT, Edit checks UAT, Clinical Data Model UAT and Reports listing UAT and execution of test steps Followed with strong documentation skills and Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. 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 Qualification Master Degree in Life Sciences