Career Category

Safety

Job Description

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 Mgr. – Global Pharmacovigilance (PV) Senior Scientist

Amgen is seeking a Global Safety Mgr. – Global Pharmacovigilance (PV) Senior Scientist to join our team and work from the Thousand Oak CA Headquarters or Amgen’s Cambridge, MA campus. Other locations may be considered. To learn more about this position:

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for:

• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.
• Perform data analysis to evaluate safety signals and write up analysis results.
• Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO).
• Direct the planning, preparation, writing and review of safety portions of aggregate reports.
• Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body.
• Assist GSO in the development of risk management strategy and activities: Provide contents for risk management plans; Develop or update strategy and content for regional risk management plans;
• Assist GSOs to supervise risk minimization activities including tracking of activities; Evaluate risk minimization activity; Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO.
• Support activities related to new drug applications and other regulatory filings: Assist GSO in developing a strategy for safety-related regulatory activities; Provide safety contents for filings.
• Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products.
• Provide support for clinical trials to review and provide input to study-related documents (e.g., study protocols; statistical analysis plans; safety-related data collection forms; and design of tables, figures, and listings for safety data from clinical studies) and provide aggregate review of Adverse Events (AEs)/Serious Adverse Events (SAEs) from clinical trials.
• Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (PV) System Master File and maintain a state of inspection readiness.
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility.

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.

Basic Qualifications

Doctorate degree and 2 years of directly related experience OR

Master’s degree and 6 years directly related experience OR

Bachelor’s degree and 8 years of directly related experience OR

Preferred Qualifications

• RN, PharmD, MPH or PA
• 2 to 3 years direct experience in pharmacovigilance: signal detection and evaluation; data analysis interpretation and synthesis; periodic report production
• Knowledge of processes and regulations for pharmacovigilance and risk management
• Clinical/medical research experience

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 improve your potential along your career journey
• A diverse and expansive 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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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 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.

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.