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Safety Data Analyst, Senior Manager (Us-Remote)

Company

Amgen
Address , Thousand Oaks, 91362, Ca
Employment type FULL_TIME
Salary $138,133 - $159,459 a year
Expires 2023-07-28
Posted at 11 months ago
Job Description
Career Category
Safety
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Safety Data Analyst, Senior Manager
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will manage changes to the global safety system and associated datamarts in Global Patient Safety reporting to a GPS Director. This role will manage the implementation of global safety system configurations. Ensure data integrity to support data analytics/reporting and manage the training of technical and business users for data analytics/reporting functionalities and associated processes
Responsibilities:
  • Supports inspection and audit activities, and the co-ordination of global safety system outputs and written responses to findings as required within remit of role
  • Lead SDA internal staff, contracted resources and budget
  • Lead timeliness and quality of SDA deliverables
  • Contribute to the development and delivery of training related to safety system and tools
  • Provide input to the development and maintenance of SOPs and other process documents
  • Partner with cross-functional collaborators in GPS, GDO and other relevant functions to establishment data integrity to support data analytics and data reporting tools
  • Chip in to efforts to improve processes and increase work efficiency applicable to the SDA responsibilities
  • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
  • Provide Safety Data Analyst (SDA) oversight of safety system configuration and output generating
  • Serve as Business Owner for the global safety system, add associated interfaces and datamarts to ensure the development, administration, and operation with collaboration of IS
  • Drive process and safety systems-related change through established governance forums
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Safety Data Analyst professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of experience Or Master’s degree and 6 years of experience Or Bachelor’s degree and 8 years of experience Or Associate’s degree and 10 years of experience Or High school diploma / GED and 12 years of experience And 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications:
  • Familiarity with statistical analysis and interpretation of aggregate safety data
  • Understanding of software development lifecycle and development standards, including validation methodology
  • Understanding of Oracle database, Oracle Developer, and standard programming languages
  • Experience in supporting inspections or internal audits
  • Personnel Management
  • Understanding of Clinical Trial and Pharmacovigilance Processes
  • Ability to establish relationships and work cross-functionally
  • Work independently; recognize and raise issues
  • Written and oral communications, leadership and problem solving
  • Pharmaceutical industry or health authority experience.
  • Understanding of global regulatory requirements for pharmacovigilance and safety reporting
  • Organization, prioritization, planning and measurement of work delivery
  • In depth knowledge of safety systems as well as query and reporting tools
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
The annual base salary range for this opportunity in the U.S. is $136,771 - $151,968.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
.
Salary Range
138,133.00 USD - 159,459.00 USD