Sr Manager - Pharmacovigilance Operations Commercial & Study Liaison in Cambridge

Overview

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

LIVE

What you will do

In this vital role, you will operate as a key strategic partner between Global Patient Safety, commercial programs, and clinical trial activities. You will ensure that all safety-relevant information generated through patient support programs, market research initiatives and clinical studies is appropriately captured, reconciled, reported and aligned with regulatory expectations. You will drive cross-functional collaboration, strengthen governance around safety reporting standards, and lead the implementation of new processes and methodologies across the Global Patient Safety organization. This position requires strong leadership, exceptional communication skills, and deep expertise in pharmacovigilance operations.

• Ensure creation and dissemination of appropriate safety reporting language in commercial and clinical trial key documents.
• Serve as primary liaison between clinical trials, commercial programs (patient support and market research), and Global Patient Safety to guarantee full collection of adverse event data.
• Initiate and support activities ensuring Global Patient Safety input into commercial initiatives.
• Oversee reconciliation activities between Global Patient Safety and commercial programs to ensure complete adverse event reporting.
• Develop and support strong cross-functional relationships and communication channels.
• Develop and communicate plans and objectives to relevant partners.
• Maintain in-depth knowledge of adverse event collection/reporting processes and safety systems, and contribute to continuous improvement of processes and methodologies.
• Lead implementation of new processes and methods across Global Patient Safety.
• Develop and maintain functional area SOPs; contribute to R&D Standards documents where applicable.
• Perform activities delegated by the QPPV as outlined in the PV System Master File and maintain an ongoing state of inspection readiness.
• Provide input to global regulatory contracting groups.
• Act as representative and point-of-contact for Health Authority inspections and Internal Process Audits within the remit of the role.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The pharmacovigilance professional we seek is an experienced leader who brings strong scientific expertise, operational excellence and the ability to influence across a global matrix environment. You will thrive in this role if you combine deep subject-matter knowledge with strong people leadership and the ability to navigate complex, fast-moving safety operations.

Basic Qualifications

• Doctorate degree and 2 years of Safety Operations experience; OR
• Master’s degree and 6 years of Safety Operations experience.

Leadership Experience

Minimum 2 years of managerial experience, either directly managing people or providing leadership through teams, projects, programs or resource allocation.

THRIVE

What you can expect of us

As we work to develop treatments that take care of others, we work to care for our teammates’ professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organization. Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act. Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.