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Global Pharmacovigilance (Pv) Senior Scientist, Obesity, Us - Remote

2+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Global Pharmacovigilance (PV) Senior Scientist, Obesity – US Remote

How Might You Defy Imagination?

At Amgen, we believe in being part of something bigger. Our mission to serve patients is at the heart of everything we do, driving our journey to become one of the world’s leading biotechnology companies. As global collaborators, we research, develop, and deliver innovative treatments that impact over 10 million patients worldwide. It’s time to pursue a career that you can be proud of.


What You Will Do

In this impactful role, the Global PV Senior Scientist will work within Therapeutic Safety Teams to manage safety deliverables throughout the product life-cycle. You’ll be involved in clinical trials, signal detection, risk management, and more.

Key Responsibilities:

  • Safety Oversight: Support clinical trial safety by providing inputs on study protocols, statistical analysis plans, and other related documents.
  • Aggregate Reports: Lead the planning, writing, and review of aggregate safety reports.
  • Cross-Functional Collaboration: Liaise with affiliates and internal partners regarding safety for assigned products.
  • Clinical Trials & Data Analysis: Review and provide input on clinical study protocols, AE/SAE data, and safety-related forms for clinical studies.
  • Signal Detection & Risk Management: Analyze safety data to identify signals, author safety documents, and assist in risk management activities and plans.
  • Regulatory Support: Contribute to regulatory filings, risk minimization strategies, and responses to health authority inquiries.
  • Inspection Readiness: Maintain inspection readiness for Health Authority Inspections and internal audits as part of the Pharmacovigilance System.

What We Expect of You

We seek a collaborative safety professional who is ready to contribute to the global fight against obesity and other serious diseases. The ideal candidate will possess:

Basic Qualifications:

  • Doctorate and 2 years of safety/pharmacovigilance experience OR
  • Master’s and 4 years of experience OR
  • Bachelor’s and 6 years of experience OR
  • Associate degree and 10 years of experience OR
  • High school diploma/GED and 12 years of experience in safety/pharmacovigilance.

Preferred Qualifications:

  • Experience in the Obesity therapeutic area.
  • Familiarity with clinical studies involving large data sets and participant numbers.

What You Can Expect of Us

At Amgen, we are committed to developing treatments that improve lives—and to supporting your personal and professional growth. In addition to a competitive base salary, Amgen offers comprehensive benefits, including:

  • Generous Retirement and Savings Plans, health, dental, and vision coverage, life insurance, and flexible spending accounts.
  • Annual bonus programs and stock-based incentives.
  • Flexible work models, including remote work arrangements.
  • Award-winning time-off policies and bi-annual company-wide shutdowns.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $142,859.00 to $168,300.00.


Apply Now

If you’re ready to change the world, [Apply Now] to join Amgen.


Amgen is an Equal Opportunity Employer

Amgen values diversity and will consider all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status. We are committed to providing reasonable accommodations to individuals with disabilities throughout the application process.