Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote

Amgen; Pennsylvania; Remote; USD 243,000 - 320,000; Full time

Job summary

A leading biotechnology company is seeking a Global Safety Officer to oversee the safety profile of products related to obesity. The role will involve leading safety signal assessments and ensuring compliance with regulatory requirements. Candidates must have an MD or DO degree and experience in pharmacovigilance. This remote position offers a competitive salary range of $243,245 to $319,267 and a comprehensive benefits package.

Benefits

Comprehensive benefits package

Annual bonus program

Flexible work models

Qualifications

• Experience in industry pharmacovigilance is preferred.
• Leadership experience in a cross-functional team environment.
• Expertise in the Obesity therapeutic area is a plus.

Responsibilities

• Serve as the safety expert for assigned products.
• Lead safety signal assessments and develop safety information.
• Prepare safety sections for regulatory filings.

Skills

Leadership

Pharmacovigilance

Clinical expertise

Education

MD or DO degree

Completion of accredited medical residency

Job description

Overview

Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote

Join Amgen’s mission to serve patients living with serious illnesses. Since 1980, Amgen has helped pioneer biotech in four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease. As a member of the Amgen team, you’ll help make a lasting impact on patients as we research, manufacture, and deliver innovative medicines.

Our award‑winning culture is collaborative, innovative, and science based. If you thrive on challenges and opportunities, you’ll grow with Amgen while transforming lives and your career.

What you will do

In this vital role within the Global Patient Safety (GPS) organization, you will serve as the safety expert for assigned development product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. You will be accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. You will lead the Safety Analysis Team (SAT) and Global Safety Team (GST) and will be a core member of the Executive Safety Committee (ESC). You will participate as a member of the Evidence Generation Team and other cross‑functional teams and may be assigned as delegate for the Therapeutic Area Head (TAH) with management of Global Safety Physicians.

• Validate safety signals and lead safety signal assessments
• Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
• Prepare/review core and regional risk management plans including additional risk minimization measures
• Prepare/review safety sections of periodic aggregate reports
• Provide safety input to protocols, statistical analysis plans, and clinical study reports
• Prepare/review safety sections of new drug applications and other regulatory filings
• Serve as safety expert on Evidence Generation Team for assigned products
• Inspection Readiness
• Travel: Domestic and International travel ~10% may be required

What we expect of you

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

Basic Qualifications:

MD or DO degree from an accredited medical school

AND

Completion of an accredited medical or surgical residency

OR

Clinical experience in either an accredited academic setting or private practice (including hospital based) setting

Preferred Qualifications:

• Industry pharmacovigilance (PV) experience
• Product safety in the bio/pharmaceutical industry or regulatory agency
• Previous management and/or mentoring experience
• Board certification or equivalent training
• Expertise in Obesity therapeutic area
• Leadership experience within the safety profile of products assigned with cross-functional team members

What you can expect from us

As we work to develop treatments that care for 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 $243,245 to $319,267. Actual salary will vary based on relevant skills, experience, and qualifications.

In addition to base salary, Amgen offers a Total Rewards Plan with eligibility for health and welfare plans, retirement savings, work/life balance, and career development opportunities, including:

• A comprehensive benefits package with group medical, dental, vision, life and disability insurance
• A discretionary annual bonus program (or field sales incentive plan where applicable)
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid options where possible

Apply now and make a lasting impact with Amgen.

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

#obesity

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.

Salary Range: 243,245.00 USD - 319,267.00 USD