23 days old

Senior Manager, PV Operations Commercial & Study Liaison (PVCSL)

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115635003
Amgen

Job ID: R-88405
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:

This role is accountable for the development of Pharmacovigilance Operations strategy for safety-related organized data collection in Amgen clinical trials and commercial activities (e.g. patient support programs and market research) in compliance with global regulatory requirements and Amgen compliance policies and standards.
  • Accountable for the review, approval and execution of PV Operations safety data collection strategy across clinical trial and commercial programs.
  • Responsible for participating in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical trials and commercial programs for all Amgen products.


Duties Include:

•Ensure the strategies of the department are executed into the safety related organized data collection activities in Amgen clinical trials and commercial activities to ensure Amgen remains compliant with global safety legislation and requirements
•Provide expert knowledge into Clinical and Commercial teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into Amgen studies and commercial activities/programs that may generate adverse event data
•Accountable as liaison between clinical trial and commercial programs (patient support and market research) and Global Patient Safety to ensure capture of all adverse event data generated by such programs and activities
•Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
•Be point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Key Activities:

•Accountable for ensuring creation and dissemination of appropriate safety reporting language in commercial and clinical trial key documents
•Accountable as liaison between clinical trial and commercial programs (patient support and market research) and Global Patient Safety to ensure capture of all adverse event data generated by such programs
•Initiate and support activities to ensure PV Operations input to commercial initiatives
•Accountable for reconciliation activities between Global Patient Safety and commercial programs to ensure reporting of all adverse event data
•Responsible for developing and supporting strong cross-functional relationships and communication
•Develop and communicate plans/objectives to others as needed
•Maintain knowledge of adverse event collection and reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods
•Lead the implementation of new processes and methods within and across Global Patient Safety
•Develop and maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable
•Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
•Provide input to GRAAS contracting groups globally
•Be representative and point of contact 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:

•Able to effectively represent ideas both verbally and in writing
•Expert knowledge of the global safety environment, regulations and guidance
•Project and/or Process Management experience & knowledge
•Expert understanding of safety data capture, representation and interpretation
•Expert knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
•Able to apply multi-disciplinary knowledge and understanding to effectively collaborate and negotiate within function and cross-functionally
•Able to organize, plan, and prioritize workload for the function

Basic Qualifications:

• Doctorate degree and 2 years of directly related experience
OR
• Master's degree and 4 years of directly related experience
OR
• Bachelor's degree and 6 years of directly related experience
OR

Associate's degree and 10 years of directly related experience

OR

High school diploma / GED and 12 years of directly experience

AND

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

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.

PI115635003

<b>Amgen</b><br/><br/><b>Job ID: </b>R-88405<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: <br><br>This role is accountable for the development of Pharmacovigilance Operations strategy for safety-related organized data collection in Amgen clinical trials and commercial activities (e.g. patient support programs and market research) in compliance with global regulatory requirements and Amgen compliance policies and standards.<br><ul><li>Accountable for the review, approval and execution of PV Operations safety data collection strategy across clinical trial and commercial programs.</li><li>Responsible for participating in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical trials and commercial programs for all Amgen products.</li></ul><br><br><b>Duties Include:</b><br><br> Ensure the strategies of the department are executed into the safety related organized data collection activities in Amgen clinical trials and commercial activities to ensure Amgen remains compliant with global safety legislation and requirements<br>Provide expert knowledge into Clinical and Commercial teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into Amgen studies and commercial activities/programs that may generate adverse event data<br>Accountable as liaison between clinical trial and commercial programs (patient support and market research) and Global Patient Safety to ensure capture of all adverse event data generated by such programs and activities<br>Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness<br>Be point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility <br><br><b> Key Activities: </b><br><br>Accountable for ensuring creation and dissemination of appropriate safety reporting language in commercial and clinical trial key documents<br>Accountable as liaison between clinical trial and commercial programs (patient support and market research) and Global Patient Safety to ensure capture of all adverse event data generated by such programs<br>Initiate and support activities to ensure PV Operations input to commercial initiatives<br>Accountable for reconciliation activities between Global Patient Safety and commercial programs to ensure reporting of all adverse event data<br>Responsible for developing and supporting strong cross-functional relationships and communication<br>Develop and communicate plans/objectives to others as needed<br>Maintain knowledge of adverse event collection and reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods<br>Lead the implementation of new processes and methods within and across Global Patient Safety<br>Develop and maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable<br>Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness<br>Provide input to GRAAS contracting groups globally<br>Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility<br>Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor<br><br><b> Knowledge and Skills: </b><br><br> Able to effectively represent ideas both verbally and in writing<br>Expert knowledge of the global safety environment, regulations and guidance<br>Project and/or Process Management experience & knowledge<br>Expert understanding of safety data capture, representation and interpretation<br>Expert knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery<br>Able to apply multi-disciplinary knowledge and understanding to effectively collaborate and negotiate within function and cross-functionally<br>Able to organize, plan, and prioritize workload for the function <br><br><b> Basic Qualifications: </b><br><br> Doctorate degree and 2 years of directly related experience<br>OR<br> Master's degree and 4 years of directly related experience<br>OR<br> Bachelor's degree and 6 years of directly related experience<br>OR <br><br> Associate's degree and 10 years of directly related experience <br><br> OR <br><br> High school diploma / GED and 12 years of directly experience <br><br> AND <br><br> 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources <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/JBGq8xcp6AwqtPJVfXzVe"> <p>PI115635003</p>

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Posted: 2019-11-20 Expires: 2019-12-21

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Senior Manager, PV Operations Commercial & Study Liaison (PVCSL)

Amgen
Thousand Oaks, CA 91360

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