4 days old

Global Safety Senior Scientist (Nurse)

Amgen
Thousand Oaks, CA 91360
  • Job Code
    116016441
Amgen

Job ID: R-87963
Location: Thousand Oaks, CA, US 91360

Amgen is a leading human therapeutics company in the biotechnology industry. For almost 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.

In our mission to serve patients, speed is absolutely critical. We're rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team - working toward our mission of advancing high potential programs for patients around the world.

As the Global Safety Senior Scientist, you will be part of a group whose purpose is to provide medical review of serious and non-serious individual case safety reports in support of safety surveillance for Amgen products. You will also support global individual case safety regulatory reporting compliance.

Primary Responsibilities
  • To assure medical validity and provide input to the activities of Medical Safety Review Team
  • To execute the medical review of ICSRs (individual case safety reports) (narratives, coding, expectedness, causality and seriousness) to ensure quality reports
  • To act as a significant point of contact between Case Managers and GSOs on medical content and regulatory reporting of ICSRs


Key Activities
  • Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality and accurate reports
  • Execute the medical review of product complaints and potential product quality problems, and assess the need for safety quality investigations
  • Execute ICSR case escalation to GSO as appropriate
  • Execute appropriate case follow up per SOPs
  • Support medical coding conventions, data collection methods, and systematic process improvements for AE processing
  • Support training to Amgen employees/vendor on ICSR medical review and assessment of safety quality investigations
  • Mentor junior GPS medical reviewers. As needed and applicable, provide direct managerial responsibilities for medical reviewers on his/her therapeutic team
  • Participate in SAT
  • Provide expertise and guidance on teams for interdepartmental and cross-functional initiatives including, process improvement standards development, SOP/MAN creation, and metrics with regards to medical review and combination product safety management
  • Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor


Inspection Readiness
  • 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
Clinical Nursing qualification and 3 years of related drug safety experience
AND
  • Knowledge of, and ability to apply, US and International safety data collection and reporting requirements for drugs, combination products and medical devices
  • Working knowledge in reviewing and assessing ICSRs and product complaint reports and identifying potential product quality problems


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.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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.

PI116016441

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87963<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is a leading human therapeutics company in the biotechnology industry. For almost 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.<br><br>In our mission to serve patients, speed is absolutely critical. We're rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team - working toward our mission of advancing high potential programs for patients around the world.<br><br>As the Global Safety Senior Scientist, you will be part of a group whose purpose is to provide medical review of serious and non-serious individual case safety reports in support of safety surveillance for Amgen products. You will also support global individual case safety regulatory reporting compliance.<br><br><b>Primary Responsibilities</b><br><ul><li>To assure medical validity and provide input to the activities of Medical Safety Review Team</li><li>To execute the medical review of ICSRs (individual case safety reports) (narratives, coding, expectedness, causality and seriousness) to ensure quality reports</li><li>To act as a significant point of contact between Case Managers and GSOs on medical content and regulatory reporting of ICSRs</li></ul><br><br><b>Key Activities</b><br><ul><li>Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality and accurate reports</li><li>Execute the medical review of product complaints and potential product quality problems, and assess the need for safety quality investigations</li><li>Execute ICSR case escalation to GSO as appropriate</li><li>Execute appropriate case follow up per SOPs</li><li>Support medical coding conventions, data collection methods, and systematic process improvements for AE processing</li><li>Support training to Amgen employees/vendor on ICSR medical review and assessment of safety quality investigations</li><li>Mentor junior GPS medical reviewers. As needed and applicable, provide direct managerial responsibilities for medical reviewers on his/her therapeutic team</li><li>Participate in SAT</li><li>Provide expertise and guidance on teams for interdepartmental and cross-functional initiatives including, process improvement standards development, SOP/MAN creation, and metrics with regards to medical review and combination product safety management</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>Inspection Readiness</b><br><ul><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><b>Basic Qualifications</b><br>Clinical Nursing qualification and 3 years of related drug safety experience<br>AND<br><ul><li>Knowledge of, and ability to apply, US and International safety data collection and reporting requirements for drugs, combination products and medical devices</li><li>Working knowledge in reviewing and assessing ICSRs and product complaint reports and identifying potential product quality problems </li></ul><br><br>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.<br><br>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.<br><br>Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.<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/7eRNagSYbbXwTZ1NF7Y5y"> <p>PI116016441</p>

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

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Global Safety Senior Scientist (Nurse)

Amgen
Thousand Oaks, CA 91360

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