Amgen

Pharmacovigilance Operations Manager

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Oct 24, 2020
Ref
R-106292
Required Education
High School or equivalent
Position Type
Full time
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.

Group Purpose:
  • 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) and vendors
  • Support interactions with, business partners (license partners) and vendors for all case intake and processing activities
  • Vendor oversight of all case intake 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


Responsible for:
  • 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
  • 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 US case follow up activities
  • Perform BP reconciliation as required by safety agreement
  • Generate and distribute performance metrics (submission compliance, volumes, turnaround times)
  • Support reviews of contract wording for case related data exchange
  • Support regulatory inspection and support for vendor audits/inspections
  • Oversee performance monitoring and relay metrics to vendors
  • Support analysis of QC trends including actions/recommendations
  • Generate, communicate, and archive report of QC findings


Basic Qualifications:
  • Doctorate degree OR
  • Master's degree and 2 years of data science and/or data science functional leadership experience OR
  • Bachelor's degree and 4 years of data science and/or data science functional leadership experience OR
  • Associate's degree and 10 years of data science and/or data science functional leadership experience OR
  • High school diploma / GED and 12 years of data science and/or data science functional leadership experience


Preferred Qualifications:
  • Degree in Science related field
  • Proficient Argus


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, as well as work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen!

Amgen provides a comprehensive Total Rewards Program designed to enhance the long term financial, physical, and overall well-being of our staff and their families. We offer competitive compensation, long term incentive opportunities, generous paid time off, 401k, medical, dental and vision just to name a few.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses 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 is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.