Specialist Software Engineer - Safety ART - Safety Reporting

4 - 12 years

0 Lacs

Posted:2 days ago| Platform: Shine logo

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On-site

Job Type

Full Time

Job Description

Role Overview: Join Amgen in their mission to serve patients by contributing as a Specialist Software Engineer in the Safety ART team, specifically focusing on Safety Reporting. Your technical expertise will be utilized to design, implement, and maintain technological solutions that support pharmacovigilance reporting and analytics, bridging the gap between safety operations and information systems to ensure data integrity, regulatory adherence, and efficient reporting through advanced systems and tools. Key Responsibilities: - Maintain pharmacovigilance systems and provide production support as a System Owner. - Support ETL (Extract, Transform, Load) pipelines for transferring PV/safety data into a data lake for reporting and analytics. - Monitor system performance, identify, and resolve technical challenges effectively. - Participate in Agile development ceremonies and practices. - Conduct code reviews to ensure code quality and consistency with standards. - Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations. - Stay informed about industry developments, emerging trends, and standard practices relevant to systems and processes. - Identify opportunities for automation and process improvements within the drug-safety ecosystem. - Collaborate with partners to prioritize system enhancements and new functionalities to meet evolving business needs. - Ensure technical implementation aspects of projects follow Information Systems Change Control and GxP validation process. - Collaborate with delivery and platform teams to align applications with approved architectural and development guidelines. - Stay knowledgeable about market trends and developments in web application development frameworks and technologies. - Support technical root cause analysis and work with software vendors to resolve pharmacovigilance systems related issues. Qualifications Required: - Masters degree with 4 to 6 years of experience in Computer Science, software development, or related field - Bachelors degree with 6 to 8 years of experience in Computer Science, software development, or related field - Diploma with 10 to 12 years of experience in Computer Science, software development, or related field Additional Company Details: Amgen is dedicated to improving the quality of life for people worldwide and fosters an inclusive environment of diverse, ethical, committed, and highly accomplished individuals who respect each other and uphold the Amgen values in advancing science to serve patients. The company ensures individuals with disabilities are provided reasonable accommodation throughout the job application process, job functions, and employment benefits and privileges. (Note: The information provided in the "What You Can Expect Of Us" section has been omitted as it pertains to the company's commitment to employee well-being and professional growth.) Role Overview: Join Amgen in their mission to serve patients by contributing as a Specialist Software Engineer in the Safety ART team, specifically focusing on Safety Reporting. Your technical expertise will be utilized to design, implement, and maintain technological solutions that support pharmacovigilance reporting and analytics, bridging the gap between safety operations and information systems to ensure data integrity, regulatory adherence, and efficient reporting through advanced systems and tools. Key Responsibilities: - Maintain pharmacovigilance systems and provide production support as a System Owner. - Support ETL (Extract, Transform, Load) pipelines for transferring PV/safety data into a data lake for reporting and analytics. - Monitor system performance, identify, and resolve technical challenges effectively. - Participate in Agile development ceremonies and practices. - Conduct code reviews to ensure code quality and consistency with standards. - Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations. - Stay informed about industry developments, emerging trends, and standard practices relevant to systems and processes. - Identify opportunities for automation and process improvements within the drug-safety ecosystem. - Collaborate with partners to prioritize system enhancements and new functionalities to meet evolving business needs. - Ensure technical implementation aspects of projects follow Information Systems Change Control and GxP validation process. - Collaborate with delivery and platform teams to align applications with approved architectural and development guidelines. - Stay knowledgeable about market trends and developments in web application development frameworks and technologies. - Support technical root cause analysis and work with software vendors to resolve pharmacovigilance systems related issues. Qualifications Required: - Masters degree with 4 to 6 years of experience in Computer Science, software development, or related field - Bachelo

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