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Associate IS -Safety ART - Signal & Risk Management

Hyderabad, Andhra Pradesh Amgen

Posted 6 days ago

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Job Description

**Join Amgen's Mission of Serving Patients**
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 - Signal & Risk Management
**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
**Preferred Qualifications:**
**Must-Have Skills**
+ Strong analytical and problem-solving skills to diagnose and resolve system-related issues.
+ Experience with data transfer processes and tackle 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 Validation of systems
**Good-to-Have Skills:**
+ Experience in Pharmacovigilance systems
+ Experience with Signal or Risk Management platforms is a plus
+ Knowledge or some experience in database programming languages such as Oracle SQL and PL/SQL
+ 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
**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
**Shift Information:**
This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
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