15 days old

Sr. Manager, Pharmacovigilance Operations

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117846984
Amgen

Job ID: R-91983
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Pharmacovigilance Operations Sr Mgr. to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position and Amgen:

This role is responsible to work cross-functionally to align post-market adverse event data collection with regulatory requirements and Amgen policies and processes.

Additional duties include:
  • Drive post-market adverse event data collection in line with regulatory requirements
  • Develop local Pharmacovigilance Operations strategy for safety-related organized data collection in Amgen commercial activities (e.g. patient support programs) in compliance with regulatory requirements and Amgen policies and standards
  • Promote compliance with pharmacovigilance data collection standards and operational consistency across commercial programs for all applicable Amgen products
  • Ensure US local variations are addressed in adhering to global requirements for safety reporting; liaise with Healthcare Compliance, R&D Compliance, Quality, Law
  • Facilitate actions between US commercial leads and Safety to implement corrective and preventative actions resulting from monitoring visits, audits and other activities
  • Partner with compliance and audit teams on monitoring visit and audit observations as applicable
  • Maintain knowledge of adverse event reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods
  • Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
  • Assist the leadership team to build an organization and processes that will support future department, company and industry challenges


Basic Qualifications:

Doctorate degree and 2 years of Pharmacovigilance experience

OR

Master's degree and 4 years of Pharmacovigilance experience

OR

Bachelor's degree and 6 years of Pharmacovigilance experience

OR

Associate's degree and 10 years of Pharmacovigilance experience

OR

High school diploma / GED and 12 years of Pharmacovigilance experience

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.

PI117846984

<b>Amgen</b><br/><br/><b>Job ID: </b>R-91983<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a <b>Pharmacovigilance Operations Sr Mgr</b>. to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position and Amgen: <br><br>This role is responsible to work cross-functionally to align post-market adverse event data collection with regulatory requirements and Amgen policies and processes.<br><br>Additional duties include:<br><ul><li>Drive post-market adverse event data collection in line with regulatory requirements</li><li>Develop local Pharmacovigilance Operations strategy for safety-related organized data collection in Amgen commercial activities (e.g. patient support programs) in compliance with regulatory requirements and Amgen policies and standards</li></ul><ul><li>Promote compliance with pharmacovigilance data collection standards and operational consistency across commercial programs for all applicable Amgen products</li><li>Ensure US local variations are addressed in adhering to global requirements for safety reporting; liaise with Healthcare Compliance, R&D Compliance, Quality, Law</li><li>Facilitate actions between US commercial leads and Safety to implement corrective and preventative actions resulting from monitoring visits, audits and other activities</li><li>Partner with compliance and audit teams on monitoring visit and audit observations as applicable</li><li>Maintain knowledge of adverse event reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods</li><li>Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility</li><li>Assist the leadership team to build an organization and processes that will support future department, company and industry challenges</li></ul><br><br><b>Basic Qualifications: </b><br><br>Doctorate degree and 2 years of Pharmacovigilance experience<br><br>OR<br><br>Master's degree and 4 years of Pharmacovigilance experience<br><br>OR<br><br>Bachelor's degree and 6 years of Pharmacovigilance experience<br><br>OR<br><br>Associate's degree and 10 years of Pharmacovigilance experience<br><br>OR<br><br>High school diploma / GED and 12 years of Pharmacovigilance experience<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/wy71mKCnJJjghJVoiqDdG"> <p>PI117846984</p>

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Posted: 2020-02-06 Expires: 2020-03-08

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Sr. Manager, Pharmacovigilance Operations

Amgen
Thousand Oaks, CA 91360

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