Safety Data Analyst (SDA) Sr. Associate
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.Safety Data Analyst (SDA) Sr. Associate
Amgen is seeking a Safety Data Analyst (SDA) Sr. Associate to join our team. To learn more:
The Associate will support pharmacovigilance activities through collaboration with end users to maintenance and improve the global safety system, ensuring end-to-end data integrity to support the provisioning of high-quality data outputs/visualizations.
- Support changes to the global safety system and associated DataMart(s)
- Support the implementation of global safety system configurations
- Support the data integrity to support data analytics and reporting
- Support the training of technical and business users for data analytics/reporting functionalities and associated processes
What you will do
Lets do this. Lets change the world. In this vital role you will perform the following activities:
- Responsible for collaborative analysis, design, build and execution of data outputs using reports (SQL), visualization and scripting language.
- Ensure delivery of automated/scheduled safety data outputs.
- Generate outputs from the global safety system in support of
- periodic safety reports (e.g., PADER, PSUR, DSUR)
- signal detection
- audits, inspections and regulatory inquires.
- Implementation of routine system configuration including reporting rule updates, product and study configuration.
- Configure safety systems for routine safety data outputs e.g. creation of Advanced Conditions, Development of User Reports.
- Augment and/or define search strategies in collaboration with leads to ensure consistent data outputs.
- Execute User Acceptance Testing (UAT) of safety system changes and study startup activities related to RAVE-Argus mapping.
- Give to the development and maintenance of technical solutions to support safety system and data outputs.
- Assist in the development of system support related process, SOPs and manuals.
- Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness.
- Support Authority Inspection and Internal Process Audits within the remit of role and responsibility.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Dynamic professional we seek is a go-getter with these qualifications.Basic Qualifications:
Bachelors degree and 2 years of directly related experience
Associates degree and 6 years of directly related experienceOr
High school diploma / GED and 8 years of directly related experiencePreferred Qualifications:
- Work experience in biotech/pharmaceutical industry
- Experience in business analytics
- Experience with Safety Database preferably Argus.
- Experience in reporting and analytic platforms such as Cognos or Business Objects
- Experience with visual management tools such as Spotfire or Tableau
- Ability to combine technical problem-solving skills with discernment to resolve best business solution
- Experience with advanced spreadsheets, modeling software, reporting software, and database design
- Strong client service orientation
- Strong consultative problem-solving skills
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a 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. Please contact us to request an accommodation.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, or disability status.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.