Job Title: Associate IS - ICSR Distribution
Location: Hyderabad, India
Work Location Type: On-site
Date Posted: February 4, 2025
Category: Safety
Company Overview:
Amgen is a leader in biotechnology, using the power of biology and technology to fight the world’s toughest diseases and improve the lives of millions of patients. With over 40 years of cutting-edge innovation, Amgen has pioneered the biotechnology industry and continues to advance medicine by using human genetic data to push the boundaries of scientific discovery.
Job Description:
As an Associate IS - ICSR Distribution, you will join a collaborative team responsible for implementing and supporting the next generation of safety platforms and supporting technologies. In this critical role, you will handle daily issues related to the processing of data and files associated with adverse events across various systems for case transmissions. You will leverage your analytical skills to ensure smooth data flow and troubleshoot system issues efficiently.
Key Responsibilities:
Data Process Supervision:
Monitor daily data processes to identify and resolve issues related to delayed or stuck files.
System & Data Reconciliation:
Address system and data reconciliation issues by collaborating with internal teams to identify root causes and implement solutions.
Collaboration & Problem Solving:
Work closely with internal and external teams to resolve system dependencies and mitigate bottlenecks.
Documentation & Process Improvement:
Maintain records of recurring issues, proposed fixes, and preventive measures to improve process reliability.
System Performance Tracking:
Develop and refine dashboards or reports to track system performance and file flow metrics.
Issue Resolution Communication:
Collaborate with stakeholders to provide regular updates on issue resolution and system performance.
Testing & Validation:
Develop and implement test plans and 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 do not impact existing functionalities.
Automation & Efficiency:
Automate repetitive testing processes and improve overall testing efficiency.
Qualifications:
Basic Qualifications:
Bachelor’s degree and 0-3 years of experience in Life Sciences, Biotechnology, Pharmacology, or Information Systems OR
Diploma and 4-7 years of experience in Life Sciences, Biotechnology, Pharmacology, or Information Systems.
Required Skills:
Strong analytical and problem-solving skills to diagnose and resolve system-related issues.
Knowledge of testing methodologies and quality assurance standards.
Proficiency in manual and automated testing methodologies.
Familiarity with regulatory compliance testing (e.g., FDA 21 CFR Part 11, GAMP).
Proficiency in data analysis and QA tools.
Knowledge of SQL (basic knowledge is helpful).
Familiarity with ITIL processes.
Preferred Qualifications:
Some experience in database programming languages using SQL.
Basic understanding of API integrations such as MuleSoft.
Strong written and verbal communication skills, with the ability to explain technical concepts to non-technical clients.
Sharp learning agility and problem-solving abilities.
Knowledge of SDLC, including requirements gathering, design, testing, data analysis, change control, and the Software Testing Life Cycle (STLC).
Familiarity with reporting tools such as Tableau.
What Amgen Offers:
At Amgen, we are committed to developing innovative treatments while ensuring your professional and personal growth. We offer a collaborative work environment, competitive benefits, and comprehensive support for your journey at every stage of your career.
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