Director Global Safety- Global Periodic Aggregate Safety Reports

Career Category

Safety

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer.  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.

DIRECTOR GLOBAL SAFETY – Global Periodic Aggregate Safety Reports

What you will do

In this vital role you will be accountable for development of Pharmacovigilance Operations strategy for the production and submission of periodic aggregate safety reports (PASRs) in compliance with global regulatory requirements and Amgen compliance policies and standards.

The Global Safety Director is accountable for all aspects of PASRs and periodic reporting processes, schedules, outputs, and metrics throughout the product’s life cycle. You will lead a global team with members in US/EU and Amgen India.

Responsible for participating in cross-functional activities to ensure and promote compliance and consistency with PASR preparation for all Amgen products throughout the life cycle of the product.

Key Responsibilities:

• Provide global leadership for PASR team to ensure all regulatory requirements for PASRs are met in the production and submission of all reports.
• Accountable for the development and maintenance of the Global Periodic Reports Schedule, Standards and Procedures
• Accountable as liaison between external vendors, Global Patient Safety, and cross functional teams (Regulatory Science, Global Clinical Development, Global Biostatistical Sciences, TS&BA, Centre for Observational Research) in the creation of PASRs
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness. ·
• Be point of contact for Health Authority Inspection and Internal Process Audits within the remit of the role and responsibility.
• Manage Global staff in functional area

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:

Doctorate degree and 4 years of Global Safety experience
OR
Master’s degree and 8 years of Global Safety experience
OR
Bachelor’s degree and 10 years of Global Safety experience

In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.  Your managerial experience may run concurrently with the required technical experience referenced above 

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 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
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

 

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

 

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Salary Range

191,067.25USD -258,502.75 USD