Associate IS - ICSR Distribution

In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies.

In this role, you will focus on solving and resolving daily issues related to processing of data and files related to adverse events across multiple systems for case transmissions.

You'll collaborate with others to ensure smooth data flow and quickly address problems, using your analytical skills to keep systems running efficiently.

• Supervise daily data processes to identify and resolve issues where files are delayed or stuck.
• Tackle system and data reconciliation issues, collaborating with teams to resolve root causes and implement solutions.
• Work with various internal and external teams to address system dependencies and mitigate bottlenecks.
• Document and maintain records of recurring issues, proposed fixes, and preventive measures to improve process reliability.
• Collaborate with stakeholders to provide updates and ensure visibility in issue resolution.
• Develop and refine dashboards or reports to track system performance and file flow metrics.
• Participate in regular team meetings to discuss challenges, insights, and recommendations for process improvement.
• Responsible for ensuring that data is adhering to the KCI metrics on a regular basis
• Develop and implement test plans, scripts to validate system updates, patches and new deployments
• Identify and document system bugs or discrepancies, collaborating with developers or vendors to resolve them.
• Perform regression testing to ensure updates or fixes do not negatively impact existing functionalities.
• Automate repetitive testing processes and improve testing efficiency.

• Bachelors degree and 0 to 3 years of Life Science/Biotechnology/ Pharmacology/ Information Systems experience OR
• Diploma and 4 to 7 years of Life Science/ Biotechnology/ Pharmacology/Information Systems experience

Basic Qualifications:

• Strong analytical and problem-solving skills to diagnose and resolve system-related issues.
• Knowledge of testing methodologies and quality assurance standard processes.
• Proficiency in working with data analysis and QA tools.
• Proficiency in manual and automated testing methodologies
• Knowledge of writing SQL will be helpful
• Familiarity with regulatory compliance testing (e.g., FDA 21 CFR Part 11, GAMP
• Familiarity with ITIL process

Preferred Qualifications:

• Knowledge or some experience in database programming languages using SQL
• Some understanding of API integrations such as MuleSoft
• Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients
• Sharp learning agility, problem solving and analytical thinking
• Knowledgeable in SDLC, including requirements, design, testing, data analysis, change control and Software Testing Life Cycle (STLC)
• Knowledgeable in reporting tools (e.g. Tableau).