PV Operations, Manager

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. Join us.

Pharmacovigilance Operations Senior Manager

Live
What you will do

Lets do this. Lets change the world. In this vital role you will act as US/EU local safety office and FDA/EMA point of contact for safety reporting and support interactions with, business partners (license partners) and vendors for all case intake and processing activities.

• Line Management of Case Management staff
• Management of all ICSR processing globally for clinical trial and post-market cases by all case processing teams.
• Ensure Vendor delivers high quality cases in a timely manner to meet all worldwide regulatory authority requirements.
• Provide vendors with resources and training to perform their role
• Analysis and communication of case QC results.
• Management of business partner relationships for case management
• Accountable for contract wording for case related data exchange
• Ensure compliance with contractual wording for case related data exchange
• Escalation of case related issues
• Providing subject matter expertise in the interpretation of regulations as it relates to case intake and processing

Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is proficient with these qualifications.
Knowledge and Skills

• Proficiency in global regulatory requirements for pharmacovigilance
• Extensive people management experience
• Expertise in all aspects of case management
• Experience in managing business partner relationships
• Experience in managing/supporting inspections
• Presentation and communication skills
• Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook

Education & Experience (Basic)

• Doctorate degree and 4 years of directly related experience OR
• Masters degree and 8 years of directly related experience OR
• Bachelors degree and 10 years of directly related experience And 4 years of managerial experience directly managing people and/or leadership experience

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.

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.

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.

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.

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.