Senior Manager, Global Pharmacovigilance Safety – Obesity

Amgen

Senior Manager for Pharmacovigilance Safety at Amgen, overseeing safety assessment activities and managing team members. Focused on innovative medicines for serious illnesses.

Posted 7/6/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $140,799 - $190,492 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance, including safety signal detection, risk management strategies, and regulatory compliance. Proficient in clinical trial oversight, data analysis, and authoring safety assessment reports.

Highest-signal resume keywords

Pharmacovigilance ExperienceSafety Signal DetectionRisk Management Strategy DevelopmentClinical Trial OversightRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data AnalysisSafety Assessment Report AuthoringStudy Protocol ReviewStatistical Analysis Plan ReviewAdverse Event ReviewSafety Data ManagementRisk Minimization ActivitiesInspection ReadinessSignal EvaluationSafety Document Preparation

Soft Skills

LeadershipMentoringCollaborationCommunicationOrganizational Skills

Tools & Technologies

Safety Information Management SystemClinical Study-Related Documents

Industry Keywords

BiotechPharmaceuticalClinical ResearchRegulatory FilingsRisk Management PlansAdverse Event DataGlobal Safety TeamPharmacovigilance RegulationsSafety Data Collection FormsCross-Functional Collaboration

About the role

Key responsibilities & impact

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
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
Maintain a state of inspection readiness.

Requirements

What you’ll need

Doctorate degree and 2 years of industry pharmacovigilance experience OR Master’s degree and 4 years of industry pharmacovigilance experience OR Bachelor's degree and 6 years of industry pharmacovigilance experience OR Associate’s degree and 10 years of industry pharmacovigilance experience OR High school diploma/GED and 12 years of industry pharmacovigilance experience
Bachelor’s in life science
2 years of managerial experience directly managing people or projects and/or mentoring experience
Clinical or medical research experience
6 years of experience in the biotech/pharmaceutical setting

Benefits

Comp & perks

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
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.