28 days old

Global Safety Sr Mgr - Devices

Amgen
Thousand Oaks, CA 91360
  • Job Code
    114881597
Amgen

Job ID: R-85857
Location: Thousand Oaks, CA, US 91360
Additional Location: US - Massachusetts - Cambridge

Amgen is seeking a Global Safety Sr Manger - Device to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position:

Amgen is a science based biotechnology pioneer. Our innovative human therapeutics have changed the practice of A, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve new patients.

Working under the supervision of the CMC Safety Physician the Device Safety Scientist will be responsible for device-related responsibilities of the CDS group for his/her assigned standalone devices and/or combination products. These responsibilities include but are not limited to device safety data collection/analysis/reporting as well as device risk management activities.

Job responsibilities include:
• Providing science-based evaluation of product quality and device safety issues for Amgen products
• Assess potential impact of quality findings on patient/user safety for all clinical and commercial products
• Review of adverse event data to detect potential product quality issues for commercial products
• Provide expertise in device safety data collection / analysis / reporting in clinical trials, device post market surveillance and reporting, device risk assessments, Human Factors study protocols and reports, and device risk / benefit analyses
• Contribute to assigned product SAT/ GST pharmacovigilance activities when they pertain to device safety, including single case assessment, aggregate data analysis, and risk management activities.
• Provide device safety expertise to protocol/ICF/CSR review and preparation of filing documents.
• Support responses to regulatory queries for safety information as required.
• Contribute to the establishment of processes/procedures and best practices related to device/combination product development and commercialization with respect to safety.
• Under supervision of CDS physician, conduct review of adverse event aggregate data in order to detect potential product/device quality issues.
• Under supervision of the CDS Physician, provide reportability assessments of product complaints/malfunctions
• For assigned products, provide review of and input to device risk management documents, including hazard analysis, use risk assessments, human factors protocols and reports, etc.
• Under supervision of CDS physician, perform authoring of device/combination product system risk/benefit analyses
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Represent and be the point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• Perform other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Basic Qualifications:

Doctorate degree & 2 years of Safety experience

OR

Master's degree & 6 years of Safety experience

OR

Bachelor's degree or & 8 years of Safety experience

OR

Associate's degree & 10 years of Safety experience

OR

High school diploma / GED & 12 years of Safety experience

Preferred Qualifications:

• Demonstrated relevant scientific training OR
Clinical experience in activities relevant to utilization of medical devices, especially as related to combination products (nursing, study management, pharmacist, etc.)
• Very strong knowledge of clinical trial device safety monitoring regulations and standards
• Strong knowledge of device development and commercialization principles including but not limited to design controls, Quality Management Systems, and other relevant standards and regulations.
• Strong knowledge of device risk management methodology, standards, and tools
• Very strong knowledge of post market safety reporting regulations/best practices for devices/combination products globally.
• Basic knowledge of signal detection principles for drugs/biologics.
• Excellent interpersonal and teamwork skills.
• Critical scientific thinking and problem solving, attention to detail.
• Organizational savvy and ability to operate effectively in a matrix environment
• Prioritization and time management skills.
• Written Communications, oral presentation and medical writing skills.
• Conflict management skills.
• Working knowledge of Microsoft Suite (Outlook, Word, Excel, PowerPoint

Additional Skills:
•Excellent interpersonal and teamwork skills.
•Critical scientific thinking and problem solving, attention to detail.
•Organizational savvy and ability to operate effectively in a matrix environment
•Prioritization and time management skills.
•Written Communications, oral presentation and medical writing skills.
•Conflict management skills.
•Working knowledge of Microsoft Suite (Outlook, Word, Excel, PowerPoint)

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.

PI114881597

<b>Amgen</b><br/><br/><b>Job ID: </b>R-85857<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>US - Massachusetts - Cambridge<br/><br/>Amgen is seeking a Global Safety Sr Manger - Device to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position: <br><br>Amgen is a science based biotechnology pioneer. Our innovative human therapeutics have changed the practice of A, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve new patients.<br><br>Working under the supervision of the CMC Safety Physician the Device Safety Scientist will be responsible for device-related responsibilities of the CDS group for his/her assigned standalone devices and/or combination products. These responsibilities include but are not limited to device safety data collection/analysis/reporting as well as device risk management activities.<br><br><b>Job responsibilities include:</b><br> Providing science-based evaluation of product quality and device safety issues for Amgen products<br> Assess potential impact of quality findings on patient/user safety for all clinical and commercial products<br> Review of adverse event data to detect potential product quality issues for commercial products<br> Provide expertise in device safety data collection / analysis / reporting in clinical trials, device post market surveillance and reporting, device risk assessments, Human Factors study protocols and reports, and device risk / benefit analyses<br> Contribute to assigned product SAT/ GST pharmacovigilance activities when they pertain to device safety, including single case assessment, aggregate data analysis, and risk management activities.<br> Provide device safety expertise to protocol/ICF/CSR review and preparation of filing documents.<br> Support responses to regulatory queries for safety information as required.<br> Contribute to the establishment of processes/procedures and best practices related to device/combination product development and commercialization with respect to safety.<br> Under supervision of CDS physician, conduct review of adverse event aggregate data in order to detect potential product/device quality issues.<br> Under supervision of the CDS Physician, provide reportability assessments of product complaints/malfunctions <br> For assigned products, provide review of and input to device risk management documents, including hazard analysis, use risk assessments, human factors protocols and reports, etc.<br> Under supervision of CDS physician, perform authoring of device/combination product system risk/benefit analyses<br> Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness<br> Represent and be the point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility<br> Perform other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor<br><br><b>Basic Qualifications:</b><br><br>Doctorate degree & 2 years of Safety experience<br><br>OR<br><br>Master's degree & 6 years of Safety experience<br><br>OR<br><br>Bachelor's degree or & 8 years of Safety experience<br><br>OR<br><br>Associate's degree & 10 years of Safety experience<br><br>OR<br><br>High school diploma / GED & 12 years of Safety experience<br><br><b>Preferred Qualifications:</b><br><br> Demonstrated relevant scientific training OR<br>Clinical experience in activities relevant to utilization of medical devices, especially as related to combination products (nursing, study management, pharmacist, etc.)<br> Very strong knowledge of clinical trial device safety monitoring regulations and standards<br> Strong knowledge of device development and commercialization principles including but not limited to design controls, Quality Management Systems, and other relevant standards and regulations.<br> Strong knowledge of device risk management methodology, standards, and tools<br> Very strong knowledge of post market safety reporting regulations/best practices for devices/combination products globally.<br> Basic knowledge of signal detection principles for drugs/biologics.<br> Excellent interpersonal and teamwork skills.<br> Critical scientific thinking and problem solving, attention to detail.<br> Organizational savvy and ability to operate effectively in a matrix environment<br> Prioritization and time management skills.<br> Written Communications, oral presentation and medical writing skills.<br> Conflict management skills.<br> Working knowledge of Microsoft Suite (Outlook, Word, Excel, PowerPoint<br><br><b>Additional Skills:</b><br>Excellent interpersonal and teamwork skills.<br>Critical scientific thinking and problem solving, attention to detail.<br>Organizational savvy and ability to operate effectively in a matrix environment<br>Prioritization and time management skills.<br>Written Communications, oral presentation and medical writing skills.<br>Conflict management skills.<br>Working knowledge of Microsoft Suite (Outlook, Word, Excel, PowerPoint)<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><br><b> Join Us </b><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>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/7eRDKGfYl5E1SZ1NF7Y5y"> <p>PI114881597</p>

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Posted: 2019-10-25 Expires: 2019-11-25

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Global Safety Sr Mgr - Devices

Amgen
Thousand Oaks, CA 91360

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