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

Amgen

2+ years

142,859.00 USD - 168,300.00 USD

Remote, USA

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.

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

Job Description

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