12 days old

Pharmacovigilance Operations Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117016505
Amgen

Job ID: R-91419
Location: Thousand Oaks, CA, US 91360

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

The Pharmacovigilance Operations Case Management team acts as the US/EU local safety office and FDA/EMA point of contact for safety reporting. They do submissions of all individual case safety reports to FDA/EMA. The team supports interactions with, business partners (license partners) distributors and CROs for all case processing activities. They are responsible for vendor oversight of all case processing activities and case quality including analysis and reporting of trends in quality measures. They ensure vendor compliance with approved processes and training requirements. This team supports interactions with business partners (license partners), distributors and CROs for all case processing activities. They also provide audit & external inspection support.

Responsibilities include:
Act as US/EU local safety office and FDA/EMA point of contact for safety reporting
Submission of all individual case safety reports to FDA/EMA, business partners (license partners) distributors and CROs
Support interactions with, business partners (license partners) distributors and CROs for all case processing activities
Vendor oversight of all case processing activities and case quality including analysis and reporting of trends in quality measures
Ensure vendor compliance with approved processes and training requirements
Audit & external inspection support
Support ICSR processing to ensure high quality cases in a timely manner to meet all worldwide regulatory authority requirements
Provide vendors with resources and training to perform their role
Support the analysis and communication of case QC results
Lead development and delivery of training materials for case management conventions
Support resolution of case related specific queries
Management of multiple business partner relationships for case management
Support reviews of contract wording for case related data exchange
Monitoring compliance in regard to regulatory submissions and/or contractual wording for data exchange
Assign tasks within Case Management to direct and indirect reports
Support management of staff within Case Management
Escalation of case processing issues
Audit & external inspection support
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
Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Key Activities:
Day-to-day vendor management issues
Interact with other local safety offices
Ensure case processing timelines for AE intake, triage and submission are met
Assess workload to assist in resource management
Support on-boarding and on-going training of vendors
Attend management meetings with vendors
Monitor workload for vendors
Support analysis of QC trends
Support generating, communicating, and archiving of reports of QC findings
Support audits of CAPAs and other actions/recommendations for ICSR quality related measures
Perform case review as required
Lead development and delivery of convention-related training material
Support training of local office staff
Perform reconciliation as required by safety agreement
Generate and distribute performance metrics (LNF, volumes, turnaround times)
Support reviews of contract wording for case related data exchange
Support regulatory inspection and support for vendor audits/inspections

Basic Qualifications:

Doctorate degree

OR

Master's degree and 2 years of safety experience
OR
Bachelor's degree and 4 years of safety experience
OR
Associate's degree and 10 years of safety experience
OR
High school diploma / GED and 12 years of safety experience

Preferred Qualifications:

Previous managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Understanding of global regulatory requirements for pharmacovigilance
People or project management experience
Competence in safety systems and medical coding
Experience in supporting inspections or internal audits

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.

PI117016505

<b>Amgen</b><br/><br/><b>Job ID: </b>R-91419<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a <b>Pharmacovigilance Operations Manager</b> to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more: <br><br>The Pharmacovigilance Operations Case Management team acts as the US/EU local safety office and FDA/EMA point of contact for safety reporting. They do submissions of all individual case safety reports to FDA/EMA. The team supports interactions with, business partners (license partners) distributors and CROs for all case processing activities. They are responsible for vendor oversight of all case processing activities and case quality including analysis and reporting of trends in quality measures. They ensure vendor compliance with approved processes and training requirements. This team supports interactions with business partners (license partners), distributors and CROs for all case processing activities. They also provide audit & external inspection support.<br><br><b>Responsibilities include:</b><br>Act as US/EU local safety office and FDA/EMA point of contact for safety reporting<br>Submission of all individual case safety reports to FDA/EMA, business partners (license partners) distributors and CROs<br>Support interactions with, business partners (license partners) distributors and CROs for all case processing activities<br>Vendor oversight of all case processing activities and case quality including analysis and reporting of trends in quality measures<br>Ensure vendor compliance with approved processes and training requirements<br>Audit & external inspection support<br>Support ICSR processing to ensure high quality cases in a timely manner to meet all worldwide regulatory authority requirements<br>Provide vendors with resources and training to perform their role<br>Support the analysis and communication of case QC results<br>Lead development and delivery of training materials for case management conventions<br>Support resolution of case related specific queries<br>Management of multiple business partner relationships for case management<br>Support reviews of contract wording for case related data exchange<br>Monitoring compliance in regard to regulatory submissions and/or contractual wording for data exchange<br>Assign tasks within Case Management to direct and indirect reports<br>Support management of staff within Case Management<br>Escalation of case processing issues<br>Audit & external inspection support<br>Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness<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>Key Activities:</b><br>Day-to-day vendor management issues<br>Interact with other local safety offices<br>Ensure case processing timelines for AE intake, triage and submission are met<br>Assess workload to assist in resource management<br>Support on-boarding and on-going training of vendors<br>Attend management meetings with vendors<br>Monitor workload for vendors<br>Support analysis of QC trends<br>Support generating, communicating, and archiving of reports of QC findings<br>Support audits of CAPAs and other actions/recommendations for ICSR quality related measures<br>Perform case review as required<br>Lead development and delivery of convention-related training material<br>Support training of local office staff<br>Perform reconciliation as required by safety agreement<br>Generate and distribute performance metrics (LNF, volumes, turnaround times)<br>Support reviews of contract wording for case related data exchange<br>Support regulatory inspection and support for vendor audits/inspections<br><br><b>Basic Qualifications:</b><br><br>Doctorate degree<br><br>OR<br><br>Master's degree and 2 years of safety experience<br>OR<br>Bachelor's degree and 4 years of safety experience<br>OR<br>Associate's degree and 10 years of safety experience<br>OR<br>High school diploma / GED and 12 years of safety experience<br><br><b>Preferred Qualifications:</b><br><br>Previous managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources<br>Understanding of global regulatory requirements for pharmacovigilance<br>People or project management experience<br>Competence in safety systems and medical coding<br>Experience in supporting inspections or internal audits<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/KMWdKzsL2PjaUpG7iXwaN"> <p>PI117016505</p>

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Posted: 2020-01-11 Expires: 2020-02-11

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Pharmacovigilance Operations Manager

Amgen
Thousand Oaks, CA 91360

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