21 days old

Global Safety Mgr

Amgen
Thousand Oaks, CA 91360
  • Job Code
    119095941
Amgen

Job ID: R-96425
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Global Safety Manager to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more:

This group supports pharmacovigilance activities through the maintenance, development and continuous improvement of the global safety system and the provisioning of high-quality data outputs/visualizations

Job Summary
  • Support changes to the global safety system and associated datamart
  • 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


Key Activities

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
  • Participate in collecting business requirements for routine safety data outputs
  • Participate in the 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


Knowledge and Skills
  • Knowledge of safety systems (ARISg/Argus) as well as query and reporting tools e.g. Cognos, Tableau
  • Understanding of Oracle database, Oracle Developer, and standard programming languages e.g. PL/SQL
  • Understanding of data warehouse concepts and data mining techniques
  • Understanding of software development lifecycle and development standards, including validation methodology
  • Understanding of global regulatory requirements for pharmacovigilance and safety reporting
  • Understanding of Clinical Trial and Pharmacovigilance Processes
  • Familiarity with statistical analysis and interpretation of aggregate safety data
  • Organization, prioritization, planning and measurement of work deliverables
  • Ability to build relationships and work cross-functionally
  • Work independently and proactively; recognize and escalate issues
  • Pharmaceutical industry or health authority experience.
  • Experience in supporting inspections or internal audits
  • Written and oral communications, leadership and problem solving


Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of biotech/pharmaceutical experience

OR

Bachelor's degree and 5 years of biotech/pharmaceutical experience

OR

Associate's degree and 10 years of biotech/pharmaceutical experience

OR

High school diploma / GED and 12 years of biotech/pharmaceutical experience

Preferred Qualifications:

• Work experience in biotech/pharmaceutical industry
• Database support work

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need 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.

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.

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.

PI119095941

<b>Amgen</b><br/><br/><b>Job ID: </b>R-96425<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Global Safety Manager to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more: <br><br>This group supports pharmacovigilance activities through the maintenance, development and continuous improvement of the global safety system and the provisioning of high-quality data outputs/visualizations<br><br>Job Summary<br><ul><li>Support changes to the global safety system and associated datamart</li><li>Support the implementation of global safety system configurations</li><li>Support the data integrity to support data analytics and reporting</li><li>Support the training of technical and business users for data analytics/reporting functionalities and associated processes</li></ul><br><br>Key Activities<br><br>With limited direction from Safety Data Analyst (SDA) - Sr. Manager, the SDA - Manager may perform the following activities:<br><ul><li>Triage, analyze and prioritize data outputs and system configuration requests</li><li>Generate outputs from the global safety system in support of<ul><li>periodic safety reports (e.g., PADER, PSUR, DSUR)</li><li>signal detection</li><li>audits, inspections and regulatory inquires</li></ul></li><li>Ensure delivery of automated/scheduled safety data outputs</li><li>Perform Quality Checks/Peer Review as needed data outputs and system</li><li>Participate in collecting business requirements for routine safety data outputs</li><li>Participate in the implementation of routine system configuration including reporting rule updates, product and study configuration</li><li>Configure safety systems for routine safety data outputs e.g. creation of Advanced Conditions, Development of User Reports</li><li>Augment and/or define search strategies in collaboration with leads to ensure consistent data outputs</li><li>Support study startup activities such as RAVE-Argus mapping User Acceptance Testing (UAT), Mapping Specifications Worksheet (MSW) approval</li><li>Participate in user UAT of safety system changes implemented</li><li>Contribute to the development and maintenance of technical solutions to support safety system and data outputs</li><li>Participate and/or lead the development and delivery of training related to safety database and tools</li><li>Assist and/or lead the development of system support related process, SOPs and manuals</li><li>Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness</li><li>Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility</li></ul><br><br>Knowledge and Skills<br><ul><li>Knowledge of safety systems (ARISg/Argus) as well as query and reporting tools e.g. Cognos, Tableau</li><li>Understanding of Oracle database, Oracle Developer, and standard programming languages e.g. PL/SQL</li><li>Understanding of data warehouse concepts and data mining techniques</li><li>Understanding of software development lifecycle and development standards, including validation methodology</li><li>Understanding of global regulatory requirements for pharmacovigilance and safety reporting</li><li>Understanding of Clinical Trial and Pharmacovigilance Processes</li><li>Familiarity with statistical analysis and interpretation of aggregate safety data</li><li>Organization, prioritization, planning and measurement of work deliverables</li><li>Ability to build relationships and work cross-functionally</li><li>Work independently and proactively; recognize and escalate issues</li><li>Pharmaceutical industry or health authority experience.</li><li>Experience in supporting inspections or internal audits</li><li>Written and oral communications, leadership and problem solving</li></ul><br><br>Basic Qualifications:<br><br>Doctorate degree<br><br>OR<br><br>Master's degree and 3 years of biotech/pharmaceutical experience<br><br>OR<br><br>Bachelor's degree and 5 years of biotech/pharmaceutical experience<br><br>OR<br><br>Associate's degree and 10 years of biotech/pharmaceutical experience<br><br>OR<br><br>High school diploma / GED and 12 years of biotech/pharmaceutical experience<br><br>Preferred Qualifications:<br><br> Work experience in biotech/pharmaceutical industry<br> Database support work<br><br><b>Amgen </b>is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.<br><br><b>Amgen</b> focuses on areas of high unmet medical need 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.<br><br><b> Amgen </b> 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. <br><br>Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/p7zLR2tDWMVzT2o5fdJ64"> <p>PI119095941</p>

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Posted: 2020-03-17 Expires: 2020-04-17

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Global Safety Mgr

Amgen
Thousand Oaks, CA 91360

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