Amgen logo
Amgen

#WeareBiotech

Global Safety Medical Director – Global Safety Officer, Oncology

Medical DirectorMedical DirectorFull TimeRemoteLeadTeam 10,001+Since 1980H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

4 days ago

Salary

$256.6K - $347.2K / year

Seniority

Lead

Postgraduate Degree2 yrs expEnglish

Job Description

Global Safety Medical Director – Global Safety Officer, Oncology

Amgen

• 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

Job Requirements

  • 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

  • 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

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