HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Pharmacovigilance Data Analytics and Reporting, Senior ManagerLive
What you will do
Lets do this. Lets 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
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
Partner with cross-functional collaborators in GPS, GDO and other relevant functions to establishment data integrity to support data analytics and data reporting tools
Provide Safety Data Analyst (SDA) oversight of safety system configuration and output generating
Lead timeliness and quality of SDA deliverables
Lead SDA internal staff, contracted resources and budget
Chip in to efforts to improve processes and increase work efficiency applicable to the SDA responsibilities
Provide input to the development and maintenance of SOPs and other process documents
Contribute to the development and delivery of training related to safety system and tools
Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
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
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Safety Data Analytics and Reporting professional we seek is a leader with these qualifications.
Doctorate degree and 2 years of experience Or Masters degree and 6 years of experience Or Bachelors degree and 8 years of experience Or Associates 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
In depth knowledge of safety systems as well as query and reporting tools
Understanding of Oracle database, Oracle Developer, and standard programming languages
Understanding of software development lifecycle and development standards, including validation methodology
Understanding of global regulatory requirements for pharmacovigilance and safety reporting
Understanding of Clinical Trial and Pharmacovigilance Processes
Familiarity with statistical analysis and interpretation of aggregate safety data
Organization, prioritization, planning and measurement of work delivery
Ability to establish relationships and work cross-functionally
Work independently; recognize and raise issues
Pharmaceutical industry or health authority experience.
Experience in supporting inspections or internal audits
Written and oral communications, leadership and problem solving
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 138,133.00 USD - 159,459.00 USD
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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
If 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 cancers, 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.
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. Please contact us to request accommodation.