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Amgen Global Safety PV Archivist Manager in Thousand Oaks, California

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Global Safety PV Archivist Manager

Safety Management group is responsible for the direction and strategy for signal detection and risk management activities. It drives policies, research, definition and implementation of innovation for safety data mining, signal detection planning, management, tracking; risk management practices, benefit/risk assessment and safety communications while ensuring quality processes with proven metrics.

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will ·

  • Establishes and influences PV archiving strategies and is accountable for monitoring compliance for the Safety PVG records collection.

  • Primary records custodian for Safety PVG records collection and maintains the index for the cabinet. Provides guidance and advice to the business with Client Facing Business Analyst (CFBA). Primary contact with vendor Archivists and reports to the Safety PVG Business Advisor.

  • Accountable to represent Amgen for internal / external audits to ensure records/data are available.

  • Serves as records point of contact with cross functional teams in support of audit activities.

  • Contributes to Safety PVG standards. Independently determines approach to leading daily operations - guided by general policies and management guidance.

  • Authors, interprets and executes policies that directly affect work activities.

  • Day-to-Day point of contact for Safety TMF and archiving

Win

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

OR

Master’s degree and 3 years of directly related experience

OR

Bachelor’s degree and 5 years of directly related experience

OR

Associate’s degree and 10 years of directly related experience

Or

High school diploma / GED and 12 years of directly related experience

Perferred skills:

  • Excellent presentation skills

  • Excellent interpersonal skills

  • Knowledge of PV (Inclusive of PVG Master File) global requirements

  • Knowledge of EDM systems and best practices

  • Records management best practices.

Thrive

Some of the vast rewards of working here

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.

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

  • A 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.

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.

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