Specialist Software Engineer - ICSR Processing

Lets do this. Lets change the world. In this vital role you will as a specialist software engineer, join a collaborative team developing and implementing the next generation of safety platforms and supporting technologies. In this role, you will be responsible for designing, developing and deploying complex software applications, and mentoring junior developers. You will work closely with the business to develop high-quality, scalable and maintainable solutions.

• Design, develop and deploy applications to support pharmacovigilance 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.

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

Or

• Bachelors degree with 6 to 8 years of experience in Computer Science, software development or related field Or

• 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 skills to seamlessly work in a cross-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.

• 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.

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

• 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

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.