Global Pharmacovigilance Senior Scientist

Amgen

Global Pharmacovigilance Senior Scientist role at Amgen executing safety assessments in medical operations. Overseeing multi-faceted safety processes in clinical trials and regulatory collaboration.

Posted 7/10/2026full-timeRemote • Kentucky, Texas, Wyoming • 🇺🇸 United StatesSenior💰 $140,799 - $190,492 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in safety assessment report writing, risk management strategy development, and regulatory compliance within the biotech and pharmaceutical sectors. Proficient in data analysis for safety signal evaluation and effective communication with cross-functional teams.

Highest-signal resume keywords

Safety Assessment Report WritingRisk Management Strategy DevelopmentRegulatory ComplianceData Analysis for Safety SignalsClinical/Medical Research Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Aggregate Report PreparationAdverse Event Data ReviewStatistical Analysis PlansSafety Data Collection Forms DevelopmentRegulatory Filing SupportRisk Minimization Activity EvaluationSignal DetectionPresentation PreparationStudy Protocol ReviewClinical Study Document Review

Soft Skills

Leadership ExperienceTeam ManagementCollaborationCommunicationMentoring

Industry Keywords

BiotechPharmaceuticalClinical TrialsHealth Authority InspectionInternal Process AuditsGSO CollaborationQPPVInspection ReadinessSafety DataRegulatory Inquiries

About the role

Key responsibilities & impact

Direct the planning, preparation, writing and review of portions of aggregate reports
Organize and direct liaison for activities with affiliates and other internal Amgen partners regarding products
Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO
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
Perform data analysis to evaluate safety signals and write up analysis results
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
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

Requirements

What you’ll need

Doctorate degree and 2 years of related experience OR Master's degree and 4 years of related experience OR Bachelor's degree and 6 years of related experience OR Associate’s degree and 10 years of related experience OR High school diploma / GED and 12 years of related experience
BS or BA in Life Science with a MS and 6 years of related experience
2 years of managerial experience directly managing people and or leadership experience leading teams, project, programs or directing the allocation of resources
Clinical/medical research experience
6 years of experience in a biotech/pharmaceutical setting
Previous management and/or mentoring experience.

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.