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

2+ years
142,859.00 USD - 168,300.00 USD
10 Nov. 18, 2024
Job Description
Job Type: Full Time Remote 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 Senior Scientist, Obesity - US Remote
Amgen
Salary Range: $142,859.00 - $168,300.00 USD

How might you defy imagination?
At Amgen, we’re driven by a shared mission—to serve patients. As one of the world’s leading biotechnology companies, we work globally to research, manufacture, and deliver life-changing products to over 10 million patients worldwide. Join us and make a difference in the world of healthcare.

What you will do:
As a Senior Scientist in Global Pharmacovigilance (PV), you’ll play a vital role in safety deliverables for assigned Amgen products throughout their life-cycles. You will be a key partner in the Therapeutic Safety Teams, ensuring safety in clinical trials, performing data analysis for signal detection, and managing risk mitigation strategies.

Key Responsibilities:

  • Support safety in clinical trials through study protocol review, safety data review, and oversight.
  • Manage and review safety-related documents, including aggregate reports and safety assessment reports.
  • Conduct signal detection and safety data analysis, including adverse event (AE) and serious adverse event (SAE) evaluation.
  • Contribute to the development of risk management strategies and oversee risk minimization activities.
  • Provide safety-related input for regulatory filings and assist in regulatory inquiries.
  • Maintain inspection readiness and represent Amgen in Health Authority inspections and audits.

Basic Qualifications:

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

Preferred Qualifications:

  • Experience in the Obesity therapeutic area.
  • Experience with clinical trials involving large datasets.

What we offer: Amgen values the growth and well-being of its employees. In addition to a competitive salary, Amgen offers comprehensive benefits, including:

  • Retirement savings plans with generous company contributions
  • Health, dental, and vision coverage
  • Life and disability insurance
  • Flexible work arrangements, including remote options
  • Career development opportunities and work-life balance

Join us and be a part of a mission that defies imagination. Apply now!

Visit Amgen Careers

Amgen is an Equal Opportunity employer. We provide reasonable accommodations for individuals with disabilities throughout the hiring process.