21 days old

Pharmacovigilance Operations Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117896204
Amgen

Job ID: R-93460
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Pharmacovigilance Operations Manager to join our team and work from beautiful Thousand Oaks, CA campus. The Manager will report to a Senior Manager of the Pharmacovigilance Operations Case Management. To learn more:

Pharmacovigilance Operations Manager include:

Vendor oversight of all case processing activities.

Support Individual Case Safety Report (ICSR) processing to ensure high quality cases meet all worldwide regulatory authority requirements.
Lead development and delivery of training materials for case management conventions.
Support resolution of case related specific queries ensuring case processing timelines are met.
Audit and external inspection support.

Support Case Management Sr. Managers by completing assigned routine and/or project specific tasks.

Escalate case processing issues to maintain a state of inspection readiness.
Interact with other local safety offices.
Submit all individual case safety reports to FDA and business partners (license partners) distributors.
Support analysis of Quality Control (QC) trends and generating communicating, and archiving of reports of QC findings.
Support audits, of CAPAs, and other actions and recommendations for ICSR quality related measures.
Develop and deliver convention-related training material and support training of local office staff.
Generate and distribute vendor performance metrics.

Basic Qualifications:

Master's degree and 2 years of directly related experience
OR
Bachelor's degree and 4 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 related experience
AND
Previous managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

Biotech, Pharmaceutical or Medical Device Industry experience

Working knowledge of global regulatory requirements for pharmacovigilance

Familiarity with end-to-end clinical development and commercialization processes

Ability to effectively represent ideas both verbally and in writing

Case processing experience and/or complete understanding of safety data capture, representation and interpretation

Proficiency in safety systems e.g. Argus, Enterprise Imaging and support tools e.g. Excel, SharePoint, PowerPoint

Experience owning a business process and/or managing CAPA investigations

Demonstrated ability to identify process improvements

Demonstrated ability to train and support new and existing staff

Interfaces effectively with stakeholders and management to resolve issues

Able to organize, plan, and prioritize workload

Understanding of global regulatory requirements for pharmacovigilance
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.

PI117896204

<b>Amgen</b><br/><br/><b>Job ID: </b>R-93460<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 beautiful Thousand Oaks, CA campus. The Manager will report to a Senior Manager of the Pharmacovigilance Operations Case Management. To learn more:<br><br><b>Pharmacovigilance Operations Manager include:</b><br><br>Vendor oversight of all case processing activities.<br><br>Support Individual Case Safety Report (ICSR) processing to ensure high quality cases meet all worldwide regulatory authority requirements.<br>Lead development and delivery of training materials for case management conventions.<br>Support resolution of case related specific queries ensuring case processing timelines are met.<br>Audit and external inspection support.<br><br>Support Case Management Sr. Managers by completing assigned routine and/or project specific tasks.<br><br>Escalate case processing issues to maintain a state of inspection readiness.<br>Interact with other local safety offices.<br>Submit all individual case safety reports to FDA and business partners (license partners) distributors.<br>Support analysis of Quality Control (QC) trends and generating communicating, and archiving of reports of QC findings.<br>Support audits, of CAPAs, and other actions and recommendations for ICSR quality related measures.<br>Develop and deliver convention-related training material and support training of local office staff.<br>Generate and distribute vendor performance metrics.<br><br><b>Basic Qualifications:</b><br><br>Master's degree and 2 years of directly related experience<br>OR<br>Bachelor's degree and 4 years of directly related experience<br>OR<br>Associate's degree and 10 years of directly related experience<br>OR<br>High school diploma / GED and 12 years of directly related experience<br>AND<br>Previous managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources<br><br><b>Preferred Qualifications:</b><br><br>Biotech, Pharmaceutical or Medical Device Industry experience<br><br>Working knowledge of global regulatory requirements for pharmacovigilance<br><br>Familiarity with end-to-end clinical development and commercialization processes<br><br>Ability to effectively represent ideas both verbally and in writing<br><br>Case processing experience and/or complete understanding of safety data capture, representation and interpretation<br><br>Proficiency in safety systems e.g. Argus, Enterprise Imaging and support tools e.g. Excel, SharePoint, PowerPoint<br><br>Experience owning a business process and/or managing CAPA investigations<br><br>Demonstrated ability to identify process improvements<br><br>Demonstrated ability to train and support new and existing staff<br><br>Interfaces effectively with stakeholders and management to resolve issues<br><br>Able to organize, plan, and prioritize workload<br><br>Understanding of global regulatory requirements for pharmacovigilance<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/ljVYjgCpZEwmtbo4uJArQ"> <p>PI117896204</p>

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Posted: 2020-02-08 Expires: 2020-03-10

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Pharmacovigilance Operations Manager

Amgen
Thousand Oaks, CA 91360

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