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Are you passionate about pharmacovigilance, data processing, and system optimization? Do you want to be part of a global biopharmaceutical leader dedicated to improving patients’ lives? Amgen is looking for an Associate IS – Safety ART – ICSR Processing to join its team in Hyderabad, India. This role offers a chance to work in a dynamic environment, supporting cutting-edge safety platforms and technologies.
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Associate IS – Safety ART – ICSR Processing – ICMA
India – Hyderabad
JOB ID: R-208638
WORK LOCATION TYPE: On Site
What you will do
Let’s do this. Let’s change the world. 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.
Roles & Responsibilities:
- 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.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
Basic Qualifications:
- Bachelor’s 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
Functional Skills:
Must-Have Skills
- Strong analytical and problem-solving skills to diagnose and resolve system-related issues.
- Experience with managing data transfer processes and resolving issues related to stuck or delayed data files.
- Knowledge of testing methodologies and quality assurance standard processes.
- Proficiency in working with data analysis and QA tools.
- Knowledge of writing SQL will be helpful
Good-to-Have Skills:
- Knowledge or some experience in database programming languages such as Oracle SQL and PL/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
- Knowledgeable in reporting tools (e.g. Tableau)
Professional Certifications (please mention if the certification is preferred or mandatory for the role):
- SAFe for Teams certification (preferred)
Soft Skills:
- Able to work under minimal supervision
- Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work
- Excellent analytical and gap/fit assessment skills
- Strong verbal and written communication skills
- Ability to work effectively with global, virtual teams
- High degree of initiative and self-motivation
- Ability to manage multiple priorities successfully
- Team-oriented, with a focus on achieving team goals
- Strong presentation and public speaking skills
Why Join Amgen?
At Amgen, we are driven by science and innovation. As part of our global safety team, you’ll contribute to ensuring that medicines are safe for patients worldwide. We offer a collaborative work environment, opportunities for career growth, and the chance to be part of groundbreaking advancements in healthcare.
