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 fieldBachelor's degree with 6 to 8 years of experience in Computer Science, software development or related fieldDiploma with 10 to 12 years of experience in Computer Science, software development or related fieldMust-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 processSupport technical implementation aspects of projects including planning, architecture, design, development, and testing to follow Information Systems (IS) Change Control and GxP validation processDemonstrate the ability to make informed technology choices after due diligence and impact assessmentGood-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 projectsExperienced with Cloud Technology such as AWS, AzureExperience with DevOpsKnowledge 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 EngineerSAFe for Teams certification (preferred)Soft Skills :
Strong verbal and written communication skillsExcellent analytical and problem-solving skillsAbility to work effectively with global, virtual teamsHigh degree of initiative and self-motivationAbility to deal with ambiguity and prioritizeTeam-oriented, with a focus on achieving team goalsAbility to influence and drive to an intended outcome and hold peers accountable, and work effectively with global, virtual teamsAbility to hold peers accountable to commitmentsSkills Required
Java, Mulesoft, Itil Management, Databricks, Sql, Python