Global Safety Sr Manager, Benefit-Risk Management - US - REMOTE
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 Senior Manager - Benefits Risk Management
What you will do
Lets do this. Lets change the world. As a part of our team, you will provide oversight and guidance of benefit-risk management processes across Amgen product portfolios and provide assistance to Safety staff as they develop structured benefit-risk assessments, risk management plans, and additional risk minimization measures.
This team is engaged in establishing and maintaining standards, templates and training for all benefit-risk management activities, compliance with global regulations related to risk management, and inspection readiness for health authority inspections.
This position is primarily a Benefit-Risk Senior Management position supporting global safety teams, cross-functional teams, and performing risk management strategy for products.
- Provides mentorship and subject matter expertise on risk management and risk minimization strategy across Amgen product portfolio
- Provide guidance to the assigned therapeutic areas on benefit-risk assessment strategies to ensure consistency
- Provide risk minimization, benchmarking, and scenario planning to identify the best strategies for risk minimization and measurement of the effectiveness of these strategies
- Offer centralized support, training, and leadership for Safety and corporate members who work on benefit-risk assessments, risk management plans (including REMS), and communications
- Provide input for the development and updates of respective standards, guides, and templates related to benefit-risk management
- Ensure Amgen adheres to and is aligned with Global Health Authority regulations regarding risk management practices
- Provide input and guidance on benefit risk related the patient perspective studies processes and deliverables
- Contributes to cross-functional initiatives aimed to improve pharmacovigilance capabilities
- Monitors risk management metrics and reports to assure Amgen is in compliance with global benefit/ risk management standards
- Assists in the development of recommendations in the process of risk management tracking and necessary compliance system improvements
- Supports inspection and audit activities with regards to the RM processes within Safety, be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
- Assist in creation of core structured benefit-risk assessments, core Risk Management Plans (RMPs), and EU RMPs. Supports development of risk management plans in a modular format and cross-use and reference of modules in PBRER etc
- Undertakes activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The leadership professional we seek has deep knowledge of industry safety and a passion for excellence. The ideal candidate will meet the following qualifications:Basic Qualifications:
- Doctorate degree and 2 years of Pharmacovigilance experience OR
- Masters degree and 6 years of Pharmacovigilance experience OR
- Bachelors degree and 8 years of Pharmacovigilance experience OR
- Associates degree and 10 years of Pharmacovigilance experience OR
- High school diploma / GED and 12 years of Pharmacovigilance experience
- Doctorate degree, M.S., OR B.S. in health science with significant advanced training.
- Deep knowledge of medical, clinical, or pharmacovigilance is required.
- 5+ years of pharmaceutical/industry experience
- 3+ years in global drug safety and risk management
- Familiarity with the management of performance metrics is desirable
- Scientist, research scientist experience planning implementation/ minimization
- Understanding and implementation of program evaluation methods, qualitative and quantitative
- Value generation experience
- Experience across multiple therapeutic areas
- Experience leading and managing teams
- Excellent verbal and written communication skills, including formal presentation skills
- Demonstrated knowledge of global aspects of drug safety
- Familiarity with industry principles of drug development and pharmacology, biostatistics, clinical trial methodology, and pharmacoepidemiology
- Strong knowledge of global safety reporting activities, regulations, and guidelines
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
Join UsIf 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, Puerto Rico and Canada 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.