Roles & Responsibilities:
- 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.
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 toJava 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
