Global Safety Sr. Associate - Thousand Oaks - 91358
172 N Moorpark Rd
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Amgen is seeking a Safety Data Analyst (SDA) Sr. Associate to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position:
Safety Data Analyst (SDA) Sr. Associate 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
With limited direction from Safety Data Analyst (SDA) - Sr. Manager, the SDA - Manager may perform the following activities:
Responsible for collaborative analysis, design, build and execution of data outputs using reports, visualization and scripting language
Ensure delivery of automated/scheduled safety data outputs
Generate outputs from the global safety system in support of
periodic safety reports (e.g., PADER, PSUR, DSUR)
audits, inspections and regulatory inquires
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
Execute User Acceptance Testing (UAT) of safety system changes and study startup activities related to RAVE-Argus mapping
Contribute to the development and maintenance of technical solutions to support safety system and data outputs
Assist in 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
Support Authority Inspection and Internal Process Audits within the remit of role and responsibility
Master's degree OR Bachelor's degree and 2 years of directly related experience OR Associate's degree and 6 years of directly related experience
Work experience in biotech/pharmaceutical industry
Experience in business analytics
Experience in reporting and analytic platforms such as Cognos or Business Objects
Experience with visual management tools such as Spotfire or Tableau
Ability to combine technical problem-solving skills with business acumen to determine best business solution
Experience with advanced spreadsheets, modeling software, reporting software, and database design
Strong client service orientation
Strong consultative problem-solving skills
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.
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.