4 days old

Signal Management Scientist - Sr. Associate

Amgen
Cambridge, MA 02138
  • Job Code
    116016752
Amgen

Job ID: R-89040
Location: Cambridge, MA, US 02139
Additional Location: US - California - Thousand Oaks

Amgen is seeking a Sr. Associate - Signal Management to join our team and work from Amgen's beautiful Cambridge, Ma, campus. To learn more about this position:

The Signal Management groupis responsible for the direction and strategy for signal detection and risk management activities. It drives policies, research, definition and implementation of innovation and best practices for safety data mining, signal detection planning, management, tracking; risk management practices, benefit/risk assessment and safety communications while ensuring quality processes with proven metrics.

This Sr. Associate supports Amgen safety signal management processes and activities reporting to the Safety Management Officer. It supports the continuous improvement to ensure that safety signal management processes reflect regulatory trends and guidelines and represent best in class.

Key Activities:
  • Supports Signal Management Process that ensure Amgen is aligned with Global Health Authority regulations regarding signal management practices
  • Monitors compliance in Amgen's internal signal tracking tool.
  • Support creation of signal metrics and reports for management.
  • Supports data mining runs and tracking outputs and signals.
  • Contributes to cross-functional initiatives aimed at development, improvement, standardization and implementation of new processes and methods related to signal detection
  • Supports inspection and audit activities
  • Contribute to the reporting of Performance Indicators for safety agreement terms relevant to vendors and partners
  • Supports cross-functional training activities
  • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
  • Be representative for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
  • Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor


Basic Qualifications:

Master's degree

OR

Bachelor's degree and 2 years of Scientific, Safety or PV experience

Preferred Qualifications:

Masters degree in Science, Safety or Public Health

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.

    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.

    PI116016752

    <b>Amgen</b><br/><br/><b>Job ID: </b>R-89040<br/><b>Location: </b>Cambridge, MA, US 02139<br/><b>Additional Location: </b>US - California - Thousand Oaks<br/><br/>Amgen is seeking a <b>Sr. Associate - Signal Management</b> to join our team and work from Amgen's beautiful Cambridge, Ma, campus. To learn more about this position: <br><br>The Signal Management groupis responsible for the direction and strategy for signal detection and risk management activities. It drives policies, research, definition and implementation of innovation and best practices for safety data mining, signal detection planning, management, tracking; risk management practices, benefit/risk assessment and safety communications while ensuring quality processes with proven metrics.<br><br>This <b>Sr. Associate</b> supports Amgen safety signal management processes and activities reporting to the Safety Management Officer. It supports the continuous improvement to ensure that safety signal management processes reflect regulatory trends and guidelines and represent best in class.<br><br>Key Activities:<br><ul><li>Supports Signal Management Process that ensure Amgen is aligned with Global Health Authority regulations regarding signal management practices</li><li>Monitors compliance in Amgen's internal signal tracking tool.</li><li>Support creation of signal metrics and reports for management.</li><li>Supports data mining runs and tracking outputs and signals.</li><li>Contributes to cross-functional initiatives aimed at development, improvement, standardization and implementation of new processes and methods related to signal detection</li><li>Supports inspection and audit activities</li><li>Contribute to the reporting of Performance Indicators for safety agreement terms relevant to vendors and partners</li><li>Supports cross-functional training activities</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 for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility</li><li>Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor</li></ul><br><br><b>Basic Qualifications:</b><br><br>Master's degree<br><br>OR<br><br>Bachelor's degree and 2 years of Scientific, Safety or PV experience<br><br>Preferred Qualifications:<br><br>Masters degree in Science, Safety or Public Health<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><b> Amgen </b> 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. <br><ul></ul><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/OaAkb2SEopRGiDqdupBkx"> <p>PI116016752</p>

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    Posted: 2019-12-03 Expires: 2020-01-03

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    Signal Management Scientist - Sr. Associate

    Amgen
    Cambridge, MA 02138

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