Manager, PV Operations Commercial & Study Liaison

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Manager, PV Operations Commercial & Study Liaison

Live

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for the development of Pharmacovigilance Operations strategy for safety-related organized data collection in Amgen clinical trials and commercial activities in compliance with global regulatory requirements and Amgen compliance policies and standards.

You will also be participating in cross-functional activities to ensure and promote compliance, with pharmacovigilance data collection standards and operational consistency across clinical trials and commercial programs for all Amgen products.

Key responsibilities

• Work on projects and process that ensures the strategies of the department are implemented into the safety related organized data collection activities in Amgen clinical trials and commercial activities to ensure Amgen remains aligned with global safety legislation and requirements.
• Provide knowledge into Clinical and Commercial teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into Amgen studies and commercial activities/programs.
• Accountable as liaison between clinical trial and commercial programs (patient support and market research) and Global Patient Safety to ensure capture of all adverse event data generated by such programs and activities
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Participate in the creation and dissemination of appropriate safety reporting language in commercial and clinical trial key documents
• Support activities to ensure PV Operations input to commercial initiatives
• Actively participates in cross functional projects that develop and support strong cross-functional relationships and communication
• Maintain knowledge of adverse event reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods
• Contribute to projects which involve the implementation of new processes and methods within and across Global Patient Safety
• Maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Act as a 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 qualified professional we seek is experienced with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Masters degree and 3 years of Pharmaceutical or Biotechnology experience

Or

Bachelors degree and 5 years of Pharmaceutical or Biotechnology experience

Or

Associates degree and 10 years of Pharmaceutical or Biotechnology experience

Or

High school diploma / GED and 12 years of Pharmaceutical or Biotechnology experience

Preferred Qualifications:

• BS/MS degree with 3-5 years of relevant experience within Pharmaceutical or Biotechnology
• Strong communication skills, with the ability to effectively represent ideas both verbally and in writing
• Extensive knowledge of the global safety environment, regulations and guidance, including compliance issues and/or scientific discovery
• Project and/or Process Management experience and knowledge
• Experience and knowledge of safety data capture, representation and interpretation
• Ability to work cross-functionally within matrix environment
• Strong organization planning and prioritizing workload

ThriveWhat you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

This position will be paid on an hourly basis. The annualized base pay range for this opportunity in the U.S. is $111,508-134,998.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

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

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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 cancers, 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.