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.
Signal Management Scientist - Senior ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will part of Amgen's Integrated Signal Management (ISM) team within Global Patient Safety. You will provide direction and strategy in the product safety signal detection and support to quality complaints trending program.
The Senior Manager position guides and leads Amgen safety signal detection and management processes and activities reporting to the Director of ISM. You will ensure that safety signal detection methods and processes are continuously improved to reflect regulatory trends and guidelines and represent best in class.
- Serve as an expert for internal signal tracking tool.
- Responsible for the data mining process, implementation of data mining and coordinating data mining runs and tracking outputs and signals.
- Contributes to the creation of signal management strategy for department through process improvement and lessons learned including the review of the Signal Management Metrics Control Plan.
- Recommends improvements to signal metrics and reports for management and responsible for the maintenance of respective standards and schedules, and ensures state of the art signal detection methodology
- Develops proposals for signal detection and optimal functioning between vendors and Safety
- Work with cross-functional initiatives aimed to improve pharmacovigilance capabilities related to signal detection and advises teams of new or revised regulatory requirements and guidelines relevant to PV Signal Management.
- Trains staff on signal detection activities and signal management processes and undertakes activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
- Be representative for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
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 Senior Manager with these qualifications.Basic Qualifications:
Doctorate degree and 2 years of pharmacovigilance or signal management experience
Masters degree and 6 years of pharmacovigilance or signal management experience
Bachelors degree and 8 years of pharmacovigilance or signal management experience
Associates degree and 10 years of pharmacovigilance or signal management experience
High school diploma/GED and 12 years of pharmacovigilance or signal management experiencePreferred Qualifications:
- Pharmaceutical industry or health authority experience.
- Pharmacovigilance processes and EU, FDA and international regulatory requirements
- Safety Information tracking and pharmacovigilance systems
- Experience in supporting inspections or internal audits
- Understanding of commercial processes and vendor interactions
- Written and oral communications, leadership and problem solving
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.
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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
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.