Global Safety Application Development - Thousand Oaks, United States - Amgen
Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.
Global Safety Application Development - Director
Live:
What you will do
Let's do this. Let's change the world.
In this vital role you will be identifying and providing recommendations to the strategic pharmacovigilance systems roadmap including the global safety database and associated systems, signal detection and signal management.
You will be overseeing and implementing strategies to enhance operational efficiency through automation and technology/innovation capabilities. As well as, contributing to the planning and implementation of new systems within Global Patient Safety.Responsibilities:
- Demonstrate knowledge of global aspects of pharmacovigilance
- Strong knowledge of processes and global regulations for pharmacovigilance and signal management processes.
- Understanding impact of emerging regulatory requirements and their implications for Amgen
- Experience working on crossfunctional teams
- Good knowledge of IT systems and IT standards
- Experience and understanding with new technology including Machine Learning, Natural Language Processing and Artificial Intelligence
- Experience in database management, system analysis and design
- Ability to effectively manage competing priorities and timelines
- Excellence in oral and written English
- Strong leadership skills, independence, networking and influencing skills and managerial experience to deal with potential conflict of stakeholders with the ability to bring a diverse group to a common decision
- Creates and ensures Amgen has proper metrics and QC in place to monitor processes
- Pharmacovigilance processes and EU, FDA and international regulatory requirements
- Quantitative and qualitative signal detection methodologies and safety data analysis
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 a driven individual with these qualifications.
Basic Qualifications:
Doctorate degree and 4 years of experience in Pharmacovigilance and/or Clinical Development
Or:
Master's degree and 8 years of experience in Pharmacovigilance and/or Clinical Development
Or:
Bachelor's degree and 10 years of experience in Pharmacovigilance and/or Clinical Development
And:
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications:
- Experience with automation within the pharmacovigilance and with technical and large system implementations
- Experience in supporting inspections or internal audits and Safety Information tracking and pharmacovigilance systems
- Understanding of commercial processes and vendor interactions
- Good knowledge of IT systems and quality requirements for GXP compliant systems
- Create insightful and progressive functional strategy
- Ability to effectively manage competing priorities and timelines
Thrive:
What 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.
- 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 salesbased incentive plan
- Stockbased longterm incentives
- Awardwinning timeoff plans and biannual companywide shutdowns
- Flexible work models, including remote work arrangements, where possible
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.
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.
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