Regulatory Jobs
Hero Gradient Background
Amgen office buildings around a landscaped plaza at its Thousand Oaks, California headquarters
Amgen logo

New · posted Nov 1

Amgen · Biotechnology

Global Pharmacovigilance (PV) Scientist, Senior Manager

  • Remote, US
  • Remote
  • Full-time
  • Manager
Save
EmploymentFull-time
LocationRemote, US
DeadlineOpen until filled

What you need

Basic Qualifications

Doctorate degree and 2 years of industry pharmacovigilance experience

Master’s degree and 4 years of industry pharmacovigilance experience

Bachelor's degree and 6 years of industry pharmacovigilance experience

Associate’s degree and 10 years of industry pharmacovigilance experience

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

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.

Preferred Qualificationsnice to have

  • BS in Life Science with 3 years drug safety experience, preferably industry pharmacovigilance experience

  • Experience in Signal detection, evaluation and management

  • Experience of Literature Surveillance: source document review knowledge and skills

  • Experience in aggregate data analysis, interpretation and synthesis

  • Good clinical and scientific judgment

  • Clinical and/or medical research experience

  • Understanding of methods of qualitative and quantitative safety data analysis

What you'll 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.

  • Directs the planning, preparation, writing and review of portions of aggregate reports

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

  • 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

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

  • 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

Pay and benefits

$141,000 – $190,000 a year

Employer provided
How this compares

140,799.10USD -190,492.90 USD

What you can expect of us

  • 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.

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:

Working conditions

Career Category

Safety

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.

A large crowd of smiling Amgen volunteers in blue shirts gathered behind a Community Day banner

From the posting

About Amgen

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.

Amgen company page · 47 open roles
Equal opportunity, accessibility and legal noticesAmgen's statements, word for word

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.

Job intelligence

The context around this role

Live data · November 3, 2026

Salary intelligence

How the pay compares

This role's midpoint is level with the US median for Clinical Safety & Pharmacovigilance roles at this level.

This roleEmployer provided

$141,000 to $190,000 a year

Manager roles in the US26 roles publishing pay

Middle half $151,000 to $179,875, median $165,750
Annual base pay
Annual base payLowMedianHigh
This role$141,000—$190,000
All US$151,000$165,750$179,875

This role: Amgen's own published range. Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, November 3, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Clinical Safety & Pharmacovigilance

The general path across 161 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not Amgen's own promotion track.

  1. Earlier

    Associate & Specialist

    Often: Associate, Pharmacovigilance Operations/Drug Safety · Clinical Safety Coordinator

    $92K median10 open
  2. One step back

    Senior & Principal

    Often: Senior Safety Scientist · Clinical FSP Quality Manager

    $172K median17 open
  3. This role

    Manager

    Often: Senior Manager, Clinical Quality Assurance · Clinical FSP Quality Manager

    $166K median30 open
  4. Next step

    Director

    Often: Director · Senior Medical Director

    $264K median91 open
  5. Later

    VP & Executive

    Often: Head of Multiple Myeloma & AML, Oncology · Head of Patient-Facing Quality Assurance

    $347K median13 open

Skills DNA

What this role leans on

How many of the posting's 36 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 3 linesLab testing and methods: 1 lineDocumentation and SOPs: 5 linesRegulatory submissions: 1 lineQuality systems and risk: 4 linesClinical trial conduct: 5 linesCollaboration and leadership: 5 linesGMPLab testingDocumentationSubmissionsQuality systemsClinical trialsTeamwork
  • Documentation and SOPs5
  • Clinical trial conduct5
  • Collaboration and leadership5
  • Quality systems and risk4
  • GMP and compliance3
  • Lab testing and methods1
  • Regulatory submissions1

Regulatory intelligence

The rules behind this role

Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

Company hiring pulse

Amgen on Regulatory Jobs

47
Open roles
45
Distinct roles
4
Locations

By discipline

  • Quality23 49%
  • Regulatory12 26%
  • Clinical12 26%

By level

  • Manager17 36%
  • Director13 28%
  • Senior & Principal12 26%
See all 47 Amgen roles

More roles at Amgen

All 47 Amgen roles

Similar Clinical Safety & Pharmacovigilance roles elsewhere

Global Pharmacovigilance (PV) Scientist, Senior Manager at Amgen

Open until filled. $141K–$190K a year, employer provided.

Job alerts