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.

Sr. Manager, Pharmacovigilance PV Operations, US – Remote

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for processing and submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. You will support all interactions with business partners (license partners) and vendors for all case intake and processing activities. You will provide vendor oversight of all intake case processing for adverse events, and intake/triage of product complaints, including analysis and reporting of trends in quality measures for rare disease portfolio. You will ensure vendor compliance with approved processes and training requirements and provide audit and inspection support.

Responsibilities

• Act as a point of contact for AE Intake processes including training, controlled documents and systems for the MariTide (AMG 133) portfolio.

• Provide Safety Intake expertise and oversight for workflow management for Data Element Standards Committee relating to development and delivery of compliant eCRF/CRFs that facilitate accurate and complete clinical trial SAE data and post market AE data are collected in line with global regulatory requirements

• Accountable as liaison between business partners (external) and PSAM (internal) to ensure capture of all adverse event data generated under PVAs.

• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness

• ICMC point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

• Provide direct ICMC subject matter expertise for eSAE Governance

• Identify and implement process improvement strategies for ICMC

• Own delivery of process content, outputs, and metrics (i.e. performance, business, and compliance metrics)

• Deliver communications within the ICMC/PV Operations

• Deliver department training programs; participates in development and modification of procedures and training material

• Support audit CAPAs and other actions/recommendations for and compliance issues are completed documents

• Participate as liaison between clinical trial and Global Patient Safety to ensure capture of all adverse event data generated by such programs

• Responsible for developing and supporting strong cross-functional relationships and communication

• Formulate and communicate plans/objectives to others as needed

• Maintain knowledge of adverse event collection and reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods

• Lead/Support the implementation of new eSAE processes and methods within and across Global Patient Safety and Global Development Operations

• Develop and maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable

• 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 their supervisor

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The safety professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of safety/ pharmacovigilance experience

OR

Master’s degree and 4 years of safety/ pharmacovigilance experience

OR

Bachelor’s degree and 6 years of safety/ pharmacovigilance experience

OR

Associate’s degree and 10 years of safety/ pharmacovigilance experience

OR

High school diploma / GED and 12 years of safety/ pharmacovigilance experience

Preferred Qualifications:

• Able to effectively represent ideas both verbally and in writing

• Expert knowledge of the global safety environment, regulations and guidance

• Project and/or Process Management experience & knowledge

• Expert understanding of safety data capture, representation and interpretation

• Expert knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

• Able to apply multi-disciplinary knowledge and understanding to effectively collaborate and negotiate within function and cross-functionally

• Able to organize, plan, and prioritize workload for the function

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $142,859. to $168,300. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

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

careers.amgen.com

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.