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Amgen logo
Amgen

#WeareBiotech

Global Safety Medical Director – General Medicine

Medical DirectorMedical DirectorOtherRemoteLeadTeam 10,001+Since 1980H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

151 days ago

Salary

$272.5K - $341.3K / year

Seniority

Lead

Postgraduate DegreeEnglish

Job Description

Global Safety Medical Director – General Medicine

Amgen

• 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

Job 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.

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