Global Pharmacovigilance (PV) Senior Scientist

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 Pharmacovigilance (PV) Senior Scientist

What you will do

Let’s do this. Let’s change the world. In this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations.

Responsibilities:

Direct the planning, preparation, writing and review of portions of aggregate reports

Organize and direct liaison for activities with affiliates and other internal Amgen partners regarding products

Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO

Supports and provides oversight to staff with regards to safety in clinical trials to:

Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents

Review of AEs/SAEs from clinical trials as needed

Review standard design of tables, figures, and listings for safety data from clinical studies

Participate in development of safety-related data collection forms for clinical studies

Participate in study team meetings as requested or needed

Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results

Documents work as required in the safety information management system

Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection

Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body

Assist GSO in the development of risk management strategy and activities:

Provides contents for risk management plans

Develop or update strategy and content for regional risk management plans

Assist GSOs to oversee risk minimization activities including tracking of activities as needed.

Evaluate risk minimization activity

Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO

Support activities related to new drug applications and other regulatory filings

Assist GSO in developing a strategy for safety-related regulatory activities

Provide safety contents for filings

Inspection Readiness

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

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 a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of related experience

OR

Master’s degree and 4 years of related experience

OR

Bachelor’s degree and 6 years of related experience

OR

Associate’s degree and 10 years of related experience

OR

High school diploma / GED and 12 years of related experience

Preferred Qualifications:

BS or BA in Life Science with a MS and 6 years of related experience

Bachelor’s degree and 8 years of related experience

2 years of managerial experience directly managing people and or leadership experience leading teams, project, programs or directing the allocation of resources

Clinical/medical research experience

6 years of experience in a biotech/pharmaceutical setting

Previous management and/or mentoring experience

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 diverse, 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 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

140,799.10USD -190,492.90 USD