Amgen

Global Safety Manager

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Feb 17, 2019
Ref
R-71424
Required Education
Masters Degree/MBA
Position Type
Full time
Amgen is seeking a Safety Data Analyst Manager to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position:

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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