Global Safety, Senior Manager

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

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.

Global Safety, Senior Manager

What you will do

Let’s do this. Let’s change the world. In this vital role the Global Safety, Senior Manager will be a single point-of-contact in the US for commercial programs (i.e., patient support programs).

Responsibilities

• Support US Local Safety Office (LSO) as point-of-contact for commercial programs working teams for patient support programs
• Develop local Pharmacovigilance Operations strategy for safety-related organized data collection in Amgen commercial activities (i.e., patient support programs) in compliance with regulatory requirements and Amgen policies and standards
• Drive and promote compliance with safety data collection standards and operational consistency across US commercial programs for all Amgen products
• Support LSO in providing oversight and monitoring compliance of safety reporting requirements in US patient support programs
• Review of local PV regulatory changes
• Liaise with PV Compliance to execute action plans and remediation activities related to safety reporting in patient support programs
• Facilitate the successful implementation of correction and preventative actions between commercial and Safety resulting from monitoring visits, audits, and other activities

Key Activities

• Responsible for developing and supporting strong cross-functional relationships and communication
• Partner with PV Compliance on monitoring visits and R&D Audit on vendor audit observations
• Lead the implementation of new processes and methods within and across Global Patient Safety
• Support LSO in undertaking activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications.

Basic Qualifications

Doctorate degree and 2 years of Safety experience

Or

Master’s degree and 4 years of Safety experience

Or

Bachelor’s degree and 6 years of Safety experience

Or

Associate’s degree and 10 years of Safety experience

Or

High school diploma / GED and 12 years of Safety experience

Preferred Qualifications

• Able to effectively represent ideas both verbally and in writing
• Sound knowledge of the global safety environment, regulations, and guidance
• Project and/or Process Management experience and knowledge
• Sound understanding of safety data capture, representation, and interpretation
• Sound 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

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. 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, based on eligibility, comprising of 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 that may include:

• A comprehensiv