24 days old

Signal Management Scientist - Senior Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    118752838
Amgen

Job ID: R-95285
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Signal Management Scientist - Senior Manager to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more:

This senior manager position guides and leads Amgen safety signal management processes and activities reporting to the Signal Management Officer. Ensures that safety signal management processes are continuously improved to reflect regulatory trends and guidelines and represent best in class. Supports Signal Management Officer in developing and maintaining signal management processes to maximize patient safety.

Key Activities:
  • Assesses impacts to business process documentation: SOPs, Manuals, templates and tools to align with Global Health Authority regulations regarding signal management practices
  • Responsible for the development and implementation of communication plans for changes in business processes
  • Contributes to the creation of signal management strategy for department through process improvement and lessons learned including the review of the Signal Management Metrics Control Plan.
  • Serve as an expert for internal signal tracking tool.
  • Recommends improvements to signal metrics and reports for management.
  • Responsible for the Data mining process. Implementation of data mining. Oversee data mining runs and tracking outputs and signals.
  • Responsible for the maintenance of respective standards and schedules, and ensures state of the art signal detection methodology
  • Proactively develops proposals for signal detection and optimal functioning between vendors and Safety
  • Serves as a Subject Matter Expert on Signal management for stakeholders internal and external to Amgen Global Safety
  • Contributes to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to signal detection
  • Informs teams of new or revised regulatory requirements and guidelines relevant to PV Signal Management.
  • Supports inspection and audit activities
  • Contributes to the development of Performance Indicator monitoring for safety agreement terms relevant to vendors and partners
  • Trains staff on signal management processes
  • Undertakes 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


Knowledge and Skills:
  • Pharmaceutical industry or health authority experience.
  • Pharmacovigilance processes and EU, FDA and international regulatory requirements
  • Quantitative and qualitative signal detection methodologies and safety data analysis
  • Safety Information tracking and pharmacovigilance systems
  • Experience in supporting inspections or internal audits
  • Understanding of commercial processes and vendor interactions
  • Written and oral communications, leadership and problem solving


Basic Qualifications:

Doctorate degree and 2 years of pharmacovigilance or signal management experience
OR
Master's degree and 6 years of pharmacovigilance or signal management experience
OR
Bachelor's degree and 8 years of pharmacovigilance or signal management experience
OR
Associate's degree and 10 years of pharmacovigilance or signal management experience
OR
High school diploma/GED and 12 years of pharmacovigilance or signal management experience

Preferred Qualifications:

• Pharmaceutical industry or health authority experience.
• Pharmacovigilance processes and EU, FDA and international regulatory requirements
• Safety Information tracking and pharmacovigilance systems
• Experience in supporting inspections or internal audits
• Understanding of commercial processes and vendor interactions
• Written and oral communications, leadership and problem solving

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.

PI118752838

<b>Amgen</b><br/><br/><b>Job ID: </b>R-95285<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a <b>Signal Management Scientist - Senior Manager</b> to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more: <br><br>This senior manager position guides and leads Amgen safety signal management processes and activities reporting to the Signal Management Officer. Ensures that safety signal management processes are continuously improved to reflect regulatory trends and guidelines and represent best in class. Supports Signal Management Officer in developing and maintaining signal management processes to maximize patient safety.<br><br>Key Activities:<br><ul><li>Assesses impacts to business process documentation: SOPs, Manuals, templates and tools to align with Global Health Authority regulations regarding signal management practices</li><li>Responsible for the development and implementation of communication plans for changes in business processes</li><li>Contributes to the creation of signal management strategy for department through process improvement and lessons learned including the review of the Signal Management Metrics Control Plan.</li><li>Serve as an expert for internal signal tracking tool.</li><li>Recommends improvements to signal metrics and reports for management.</li><li>Responsible for the Data mining process. Implementation of data mining. Oversee data mining runs and tracking outputs and signals.</li><li>Responsible for the maintenance of respective standards and schedules, and ensures state of the art signal detection methodology</li><li>Proactively develops proposals for signal detection and optimal functioning between vendors and Safety</li><li>Serves as a Subject Matter Expert on Signal management for stakeholders internal and external to Amgen Global Safety</li><li>Contributes to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to signal detection</li><li>Informs teams of new or revised regulatory requirements and guidelines relevant to PV Signal Management.</li><li>Supports inspection and audit activities</li><li>Contributes to the development of Performance Indicator monitoring for safety agreement terms relevant to vendors and partners</li><li>Trains staff on signal management processes</li><li>Undertakes 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>Knowledge and Skills:<br><ul><li>Pharmaceutical industry or health authority experience.</li><li>Pharmacovigilance processes and EU, FDA and international regulatory requirements</li><li>Quantitative and qualitative signal detection methodologies and safety data analysis</li><li>Safety Information tracking and pharmacovigilance systems</li><li>Experience in supporting inspections or internal audits</li><li>Understanding of commercial processes and vendor interactions</li><li>Written and oral communications, leadership and problem solving</li></ul><br><br>Basic Qualifications:<br><br>Doctorate degree and 2 years of pharmacovigilance or signal management experience<br>OR<br>Master's degree and 6 years of pharmacovigilance or signal management experience<br>OR<br>Bachelor's degree and 8 years of pharmacovigilance or signal management experience<br>OR<br>Associate's degree and 10 years of pharmacovigilance or signal management experience<br>OR<br>High school diploma/GED and 12 years of pharmacovigilance or signal management experience<br><br>Preferred Qualifications:<br><br> Pharmaceutical industry or health authority experience.<br> Pharmacovigilance processes and EU, FDA and international regulatory requirements<br> Safety Information tracking and pharmacovigilance systems<br> Experience in supporting inspections or internal audits<br> Understanding of commercial processes and vendor interactions<br> Written and oral communications, leadership and problem solving<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/wylybAFnPq1BsJVoiqDdG"> <p>PI118752838</p>

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Posted: 2020-03-05 Expires: 2020-04-05

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Signal Management Scientist - Senior Manager

Amgen
Thousand Oaks, CA 91360

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