Amgen

Global Safety Medical Director – General Medicine

Amgen

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $272,481 - $341,319 per year

Job Level

Lead

About the role

  • Validate safety signals and lead safety signal assessments
  • Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
  • Prepare/review core and regional risk management plans including additional risk minimization measures
  • Prepare/review safety sections of periodic aggregate reports
  • Provide safety input to protocols, statistical analysis plans, and clinical study reports
  • Prepare/review safety sections of new drug applications and other regulatory filings
  • Serve as safety lead on Evidence Generation Team for assigned products
  • Inspection Readiness

Requirements

  • MD or DO degree from an accredited medical school AND Completion of an accredited medical or surgical residency
  • Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
  • Industry pharmacovigilance (PV) experience
  • Product safety in the bio/pharmaceutical industry or regulatory agency
  • Previous management and/or mentoring experience
  • Board certification or equivalent training
  • Leadership experience within the safety profile of products assigned with cross-functional team members.
Benefits
  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
safety signal validationrisk management planningsafety report preparationregulatory filing preparationclinical study reportingstatistical analysiscore safety information developmentrisk minimization measurespharmacovigilanceproduct safety assessment
Soft Skills
leadershipmentoringcross-functional collaborationcommunicationorganizational skillsteam managementinspection readiness
Certifications
MD degreeDO degreeboard certification