12 days old

Senior Manager, PV Operations Commercial & Study Liaison eSAE BPO

Amgen
Thousand Oaks, CA 91360
Apply Now
Apply on the Company Site
  • Job Code
    128275160
Amgen

Job ID: R-109951
Location: Thousand Oaks, CA, US

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 read over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

Senior Manager, PV Operations Commercial & Study Liaison eSAE BPO

Live

What you will do

Let's do this. Let's change the world. In this vital role you will act as business process owner (BPO) and point of contact for end-to-end eSAE (electronic) safety reporting.
  • Role spans across both Global Development Operations and Global Patient Safety organizations
  • Providing project management support and coordinating achievement of deliverables for the eSAE project and governance
  • Ensure clinical trial SAE data and post market AE data are collected in line with global regulatory requirements
  • Support interactions with internal partners across Global Development Operations and Global Patient Safety for eSAE safety reporting activities
  • Ensure the strategies of the departments are executed into the safety related organized data collection activities in Amgen clinical trials and commercial activities to ensure Amgen remains compliant with global safety legislation and requirements
  • Provide expert knowledge to Clinical teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into Amgen studies activities/programs that may generate adverse event data


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a champion with these qualifications.
  • Day-to-day issues management for eSAE project and processes
  • Oversee eSAE Governance Team meetings
  • Identify and implement process improvement strategies
  • Own process content, deliverables/outputs, and metrics (i.e. performance, business, and compliance metrics)
  • Manage communications within the PV Operations and Global Development Operations departments related to eSAE
  • Contributes to the design and content development of department training programs; participates in development and modification of procedures and training material
  • Provide subject matter expertise in the interpretation of regulations as related to eSAE
  • Audit/inspection response SME for eSAE project workstream
  • Ensure audit CAPAs and other actions/recommendations for eSAE and compliance issues are completed


Education/Experience:

Doctorate degree and 2 years of directly related experience Or

Master's degree and 6 years of directly related experience Or

Bachelor's degree and 8 years of directly related experience And 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Thrive

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


Apply now 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.

careers.amgen.com

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.

Join Us

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.



PI128275160
Posted: 2021-01-06 Expires: 2021-02-07

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Senior Manager, PV Operations Commercial & Study Liaison eSAE BPO

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast