Case Management - Specialist (Device Safety)

hin them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do

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.

Job Summary:

• Accountable for quality of device/combination product Individual Case Safety Reports (ICSR) processing globally for clinical trial and post-market cases.

• Ensure Vendors deliver high quality device/combination product cases through metric management and meet all worldwide regulatory authority requirements.

• Provide vendors with resources and training to perform their role.

• Responsible for raise of device/combination product case related issues.

• Providing audit/inspection support for case management related activities including liaising with vendors to provide support as applicable for device/combination products.

• 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.

Key Activities:

• Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes.

• Ensures compliance and timely reporting with device/combination product cases through query process.

• Contributes to the implementation of new intake-related systems, processes and procedures within the process.

• Supports an engaging culture.

• Ensures quality of PC, AE and OSF records.

• Applies analytical skills to evaluate moderately complex situations using multiple sources of information while applying multiple systems.

• Implements Standard Operating Procedure requirements for device/combination product cases.

• Develops solutions to technical problems up to moderate complexity.

Knowledge and Skills:

• Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices).

• Familiarity with clinical development process.

• Demonstrating high case level productivity and quality.

• Attention to detail.

• Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree and 4 years of Drug Safety or Life Sciences experience OR

• Master's degree and 7 years of Drug Safety or Life Sciences experience OR

• Bachelor's degree and 9 years of Drug Safety or Life Sciences experience.

Education & Experience (Preferred):

• Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry.

• Bachelor's Degree in a health-care subject area or scientific field.

• Previous experience with a corporate intake system or safety database.

• Ability to successfully manage workload to strict timelines.

• Familiarity with basic project management tools.

• Demonstrated ability to consistently deliver on-time, and high-quality results.

• Ability to operate in a matrixed or team environment.

• Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices).

What you can expect of us

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.

Apply now for a career that defies imagination

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

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