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Amgen Pharmacovigilance Operations Manager in Thousand Oaks, California

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.​

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