Amgen Pharmacovigilance Operations, Senior Manager in Thousand Oaks, California
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. Join us.
Pharmacovigilance Operations, Senior Manager
Amgen is seeking a Pharmacovigilance Operations Sr Mgr . to join our team and work from Amgen’s beautiful Thousand Oaks, CA campus. To learn more about this position and Amgen:
This role is responsible to work cross-functionally to align post-market adverse event data collection with regulatory requirements and Amgen policies and processes.
What you will do
Let’s do this. Let’s change the world. In this vital role you will Drive post-market adverse event data collection in line with regulatory requirements
Develop local Pharmacovigilance Operations strategy for safety-related organized data collection in Amgen commercial activities (e.g. patient support programs) in compliance with regulatory requirements and Amgen policies and standards
Promote compliance with pharmacovigilance data collection standards and operational consistency across commercial programs for all applicable Amgen products
Work effectively and liaise with various cross functions such as US Commercial organizations, Healthcare Compliance, R&D Compliance, Quality, Law, and Privacy
Facilitate actions between US commercial leads and Safety to implement corrective and preventative actions resulting from monitoring visits, audits and other activities
Partner with compliance and audit teams on monitoring visit and audit observations as applicable
Maintain knowledge of adverse event reporting process and safety system and give to the development, improvement and standardization of new processes and methods
Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
Assist the leadership team to build an organization and processes that will support future department, company and industry challenges
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.
Doctorate degree and 2 years of Pharmacovigilance experience
Master’s degree and 4 years of Pharmacovigilance experience
Bachelor’s degree and 6 years of Pharmacovigilance experience
Associate’s degree and 10 years of Pharmacovigilance experience
High school diploma / GED and 12 years of Pharmacovigilance experience
What you can expect of us
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.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Equal 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.
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 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.