Amgen

Global Safety Sr. Associate

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Mar 22, 2019
Ref
R-71446
Required Education
Masters Degree/MBA
Position Type
Full time
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

Responsibilities:

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)

signal detection

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

Basic Qualifications:

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

Preferred Qualifications:

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.

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.