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Global Safety Medical Director – Global Safety Officer, Oncology
AmgenGlobal Safety Medical Director overseeing pharmacovigilance and product safety strategy at Amgen. Leading cross-functional safety teams to establish product safety profile and manage risk communication.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance activities, including risk management, benefit-risk evaluation, and regulatory compliance. Possesses strong leadership skills to guide safety teams and manage partnerships in the bio/pharmaceutical industry.
Highest-signal resume keywords
MD Or DO DegreeGlobal Safety ExperienceOncology ExperienceProduct Safety ManagementRegulatory Filings
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
PharmacovigilanceRisk ManagementBenefit-Risk EvaluationClinical Trial SafetyNew Drug ApplicationsSafety AnalysisSafety CommunicationInspection ReadinessSafety Agreement DevelopmentSafety Document Review
Soft Skills
LeadershipMentoringCollaborationCommunication
Industry Keywords
Bio/Pharmaceutical IndustryOncology ProductsClinical ExperienceResidency CompletionCommercialization Process
About the role
Key responsibilities & impact- Safety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities.
- Accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.
- Leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC).
- Product safety profile, benefit-risk evaluation, and risk communication
- Clinical trial safety Brochure and Informed Consent Form
- New drug applications and other regulatory filings
- Risk management and minimization
- Commercialization Process
- Inspection Readiness
- Partnerships and integration activities
- Participate in safety agreement development and review process
- Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement
Requirements
What you’ll need- MD or DO degree from an accredited medical school
- Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
- 2+ years of industry Global Safety experience
- Oncology experience in early development.
- Product safety in the bio/pharmaceutical industry or regulatory agency
- Previous management and/or mentoring experience
- Experience with oncology products/early development
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
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible