Case Management QA Vendor Associate

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Case Management QA Vendor Associate

Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support.

• Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases processed by vendors
• Ensure Vendors deliver high quality cases through metric management meet all worldwide regulatory authority requirements
• Provide vendors with resources and training to perform their role
• Analysis and communication of case Quality Control results
• Responsible for escalation of case related issues from vendor(s)
• Providing audit/inspection support for case management related activities, including liaising with vendors to provide support as applicable
• Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness
• May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable
• Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor · Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes
• Ensure vendor case processing timelines for AE intake, triage and submission are met
• Perform retrospective quality assurance of vendor processed cases
• Day-to-day vendor management issues
• Interact with other local safety offices as applicable
• Support on-boarding and off-boarding of vendor staff
• 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
• Generate and distribute performance metrics (retro QA / Case correction)
• Support analysis of QC trends including actions/recommendations

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Bachelor's degree and 3 years of directly related experience (OR)
• Associate's degree and 5 years of directly related experience (OR)
• High school diploma / GED and 7 years of directly related experience (AND)
• Previous experience directly managing teams, projects, programs or directing the allocation of resources

Preferred Skills:

• Understanding of global regulatory requirements for pharmacovigilance
• Proficiency in safety case processing
• Expertise in all aspects of case intake and processing in multiple global safety databases
• Experience in supporting inspections or internal audits
• Communication skills and attention to detail
• Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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.