Global Safety Manager
- Employer
- Amgen
- Location
- Thousand Oaks, CA, US
- Start date
- Feb 17, 2019
View more
- Discipline
- Administration, Clinical, Drug Safety/Pharmacovigilance
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
Safety Data Analyst (SDA) Manager will support pharmacovigilance activities through collaboration with end users to maintenance and improve the global safety system, ensuring end-to-end data integrity to support the provisioning of high-quality data outputs/visualizations:
Support changes to the global safety system and associated datamart(s)
Support the implementation of global safety system configurations
Support the data integrity to support data analytics and reporting
Support the training of technical and business users for data analytics/reporting functionalities and associated processes.
Responsibilities:
With limited direction from Safety Data Analyst (SDA) - Sr. Manager, the SDA - Manager may perform the following activities:
Triage, analyze and prioritize data outputs and system configuration requests
Generate outputs from the global safety system in support of
- periodic safety reports (e.g., PADER, PSUR, DSUR)
- signal detection
- audits, inspections and regulatory inquires
Ensure delivery of automated/scheduled safety data outputs
Perform Quality Checks/Peer Review as needed data outputs and system
Monitor Quality Measure to ensure the high-quality data outputs/visualizations
Participate in collecting business requirements for routine safety data outputs
Implementation of routine system configuration including reporting rule updates, product and study configuration
Configure safety systems for routine safety data outputs e.g. creation of Advanced Conditions, Development of User Reports
Augment and/or define search strategies in collaboration with leads to ensure consistent data outputs
Support study startup activities such as RAVE-Argus mapping User Acceptance Testing (UAT), Mapping Specifications Worksheet (MSW) approval
Participate in user UAT of safety system changes implemented
Contribute to the development and maintenance of technical solutions to support safety system and data outputs
Participate and/or lead the development and delivery of training related to safety database and tools
Assist and/or lead the development of system support related process, SOPs and manuals
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
Basic Qualifications:
- Master's degree
OR
Bachelor's degree and 4 years of directly related experience
OR
Associate's degree and 8 years of directly related experience
Preferred Qualifications:
- Pharmaceutical industry or health authority experience
- Pharmacovigilance processes and EU, FDA and international regulatory requirements
- Experience in supporting inspections or internal audits
- Experience in safety systems including Argus, ARISg
- Experience in reporting and analytic platforms such as Cognos or Business Objects
- Ability to combine technical problem-solving skills with business acumen to determine best business solution
- Written and oral communications, leadership and problem solving
Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.
Amgen focuses on areas of high unmet medical needs and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.
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.
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Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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