Global Safety Sr Manager - Inflammation

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.

Global Safety Sr Manager - Inflammation

Live

What you will do

Lets do this. Lets change the world. In this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise as needed to GPS. Applicable tasks may vary by product(s) assigned.

• Contributes to the planning, preparation, writing and review of non-medical portions of aggregate reports
• Works with affiliates and other internal Amgen partners regarding deliverables
• Review of AE/SAEs from clinical trials as needed
• Contributes under the direction of the Global PV Sr. Scientist or Lead to:
• Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
• Review standard design of tables, figures, and listings for safety data from clinical studies
• Participate in development of safety-related data collection forms for clinical studies
• Attend study team meetings as requested or needed
• Conduct signal detection, evaluation, and management
• Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO
• Prepare safety assessment reports and other safety documents and regulatory responses
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
• Participates in Safety Governance per Amgen processes
• Prepare presentation of the Global Safety Teams recommendations on safety issues to the cross-functional decision-making body
• Assist GSOs and other Senior Scientists in the development of risk management strategy and activities
• Provides contents for risk management plans
• Update strategy and content for regional risk management plans
• Assist GSOs to oversee risk minimization activities including tracking of activities as needed
• 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/ or other Senior Scientist in developing a strategy for safety-related regulatory activities
• Provide safety contents for filings
• Performs other duties related to the position as vital as defined in Standard Operating Procedures or as requested by his/her supervisor

Inspection Readiness

• Undertake activities delegated by the QPPV as detailed in the 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
• Contribute to the development, improvement, and standardization of pharmacovigilance processes and methods
• Participates on teams for the implementation of new processes and methods within the Therapeutic Area
• Processes and regulations for pharmacovigilance and risk management
• Drug development and lifecycle management
• Safety data capture in clinical development and post-market settings
• Safety database structure and conventions
• MedDRA and other dictionaries used in pharmacovigilance
• Methods of qualitative and quantitative safety data analysis
• Product and disease state knowledge
• Risk management and risk minimization
• Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling
• Sophisticated understanding of interfaces across various pharmacovigilance and risk management processes
• Internal organizational and governance structure

Pharmacovigilance skills:

• Signal detection, evaluation and management
• Aggregate data analysis
• Good clinical and scientific judgment
• Application of medical concepts and terminology
• Document writing and source document review
• Data interpretation and synthesis
• Basic skills in application of statistical and epidemiological methods to pharmacovigilance
• Ability to convey complex, scientific data in an understandable way
• Ability to analyze and interpret complex safety data
• Beginning skills in writing Risk Management Plans

Other skills:

• Organization, prioritization, planning skills
• Collaboration with cross-functional team settings
• Meeting management and time leadership skills
• Process and project management
• Critical scientific assessment and problem solving
• Strong written and verbal communications skills, including medical/scientific writing
• Computer skills (e.g., MS Office Suite and safety systems)
• Critical thinking
• Influencing and negotiation in a cross-functional, matrix environment
• Presentation skills for conveying complex technical contents to non-expert audiences

This position could also be located remotely.

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek is a champion with these qualifications.

Basic Qualifications

• Doctorate degree OR
• Masters degree and 6 years of drug safety experience OR
• Bachelors degree and 8 years of drug safety experience OR
• Associates degree and 10 years of drug safety experience Or
• High school diploma / GED and 12 years of drug safety experience

Preferred Qualifications

• BS or BA in Life Science with a MS and 3 years of drug safety experience OR
• Bachelors degree and 5 years of drug safety experience

And

• Previous managerial experience directly managing people and/or experience leading teams, project, programs or advising the allocation of resources
• Clinical/medical research experience
• Experience in a biotech/pharmaceutical setting

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.

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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.