Specialist Software Engineer - ICSR Intake

Roles & Responsibilities:

• Design, develop and deploy applications to support pharma covigilance systems.
• Develop and maintain solutions to enhance E2E data reconciliation, ensuring consistency and accuracy across systems related to adverse events/product complaints
• Develop innovative solutions using generative AI technologies including large language models (LLMs) like Open AI GPT for enhanced decision making and drive efficiency
• Using strong rapid prototyping skills, quickly translate concepts into working code.
• Conduct code reviews to ensure code quality and consistency to standards.
• Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations.
• Identify and resolve technical challenges effectively.
• Stay informed about industry developments, emerging trends, and standard practices relevant to systems and processes
• Work with partners to identify and prioritize system enhancements and new functionalities to meet evolving business needs of drug-systems.
• Find opportunities for automation and process improvements within drug-safety ecosystem.
• Overall accountability of technical implementation aspects of projects including planning, architecture, design, development, and testing to follow Information Systems Change Control and GxP validation process.
• Collaborate with the delivery and platform teams to ensure that the applications are aligned with approved architectural and development guidelines.
• Maintain knowledge of market trends and developments in web application development frameworks and related and new technologies to provide, recommend, and deliver standard methodology solutions.
• Responsible for supporting technical root cause analysis and work with software vendors to resolve Pharmacovigilance systems related issues.

Basic Qualifications and Experience:

• Master s degree with 4 to 6 years of experience in Computer Science, software development or related field
• Bachelor s 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

• Must-Have Skills:

  Experienced in database programming languages, data modelling concepts, using SQL and Databricks.
• Experienced with reporting tools such as Tableau and Power BI.
• Experienced in one or more general programming languages, including but not limited to: Java or Python.
• Excellent problem-solving skills and a commitment to resolving challenges.
• 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.
• Extensive experience with SDLC.
• Collaborative spirit and effective communication to seamlessly work in a multi-functional team.
• An ongoing commitment to learning and staying at the forefront of AI/ML advancements.
• Experience with Application Programming Interface (API integrations) such as MuleSoft and Extract Transform Load (ETL tools) as Informatica platform, and Databricks.
• Outstanding ability to explain technical concepts to non-technical clients.
• Knowledge with ITIL process
• Support technical implementation aspects of projects including planning, architecture, design, development, and testing to follow Information Systems (IS) Change Control and GxP validation process
• Demonstrate the ability to make informed technology choices after due diligence and impact assessment

• Good-to-Have Skills:

  3+ years of experience COTS Pharmacovigilance Platforms (for example Argus) is a plus or other safety database.
• Experienced in managing GxP systems and implementing GxP projects
• Experienced with Cloud Technology such as AWS, Azure
• Experience with DevOps
• 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.

Professional Certifications:

• Certified SAFe Agile Software Engineer
• SAFe for Teams certification (preferred)

Soft Skills:

• Strong verbal and written communication skills
• Excellent analytical and problem-solving skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to deal with ambiguity and prioritize
• Team-oriented, with a focus on achieving team goals
• Ability to influence and drive to an intended outcome and hold peers accountable, and work effectively with global, virtual teams
• Ability to hold peers accountable to commitments