- 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 cross-functional 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 analysisWinWhat 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 DevelopmentOr Masters degree and 8 years of experience in Pharmacovigilance and/or Clinical DevelopmentOr Bachelors degree and 10 years of experience in Pharmacovigilance and/or Clinical DevelopmentAnd 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 along with strong leadership skillsThriveWhat 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. 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 possibleApply nowfor 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. 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.
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Global Safety Application Development - Thousand Oaks, United States - Amgen
Description
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.
Global Safety Application Development - DirectorLive
What you will do
Lets do this. Lets 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:
