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Posted: 10/20/2026Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance, including safety assessment, signal detection, and regulatory compliance within the biotech and pharmaceutical industries. Proficient in managing clinical trial safety activities and authoring safety-related documents.
Highest-signal resume keywords
Pharmacovigilance ExperienceClinical Trial Safety ManagementSafety Assessment Report AuthoringRegulatory ComplianceManagerial Experience
About the role
Key responsibilities & impact- Work with Therapeutic Safety Teams on safety assessment activities for medical/scientific operations
- Direct planning, preparation, writing and review of portions of aggregate reports
- Organize and direct liaison activities with affiliates and internal Amgen partners regarding products
- Support and oversee staff regarding clinical-trial safety activities
- Review study protocols, statistical analysis plans and clinical study-related documents
- Review adverse events and serious adverse events from clinical trials
- Review safety data tables, figures and listings
- Participate in developing safety-related data collection forms and study team meetings
- Perform signal detection, evaluation and management through safety-data analysis
- Document work in the safety information management system
- Author Safety Assessment Reports, safety documents and regulatory responses
- Search and review adverse-event data, literature and other safety-relevant data for signal detection
- Present Global Safety Team recommendations to cross-functional decision-making bodies
- Assist with risk-management strategies, plans, risk minimization activities and regulatory inquiries
- Support safety-related activities for new drug applications and other regulatory filings
- Maintain inspection readiness and serve as a contact for Health Authority inspections and Internal Process Audits
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
- 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
- Sponsorship for this role is not guaranteed
Benefits
Comp & perks- Comprehensive employee benefits package
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
- Work/life balance support
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Safety Data AnalysisSignal DetectionAdverse Event ReviewClinical Study Protocol ReviewAggregate Report WritingRisk Management StrategiesSafety Information Management SystemData Collection Form DevelopmentStatistical Analysis Plan ReviewInspection Readiness
Soft Skills
LeadershipMentoringCollaborationCommunicationOrganizational Skills
Industry Keywords
BiotechPharmaceuticalClinical ResearchHealth Authority InspectionsRegulatory FilingsSafety Data TablesSerious Adverse EventsGlobal Safety TeamInternal Process AuditsRisk Minimization Activities