Amgen

#WeareBiotech

Global Safety Director – Obesity

DirectorDirectorFull TimeRemoteTeam 10,001+Since 1980H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

41 days ago

Salary

$190.0K - $246.2K / year

4 yrs expEnglish

Job Description

• Serve as the safety expert of the assigned product(s) within the Obesity portfolio • Establish the strategy, direction, and priorities of pharmacovigilance activities • Be accountable for the overall safety profile and all product-related decisions and deliverables for assigned products • Lead the Safety Analysis Team (SAT), Global Safety Team (GST) and be a core member of the Executive Safety Committee (ESC) • 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 • Provide safety input to protocols, statistical analysis plans, and clinical study reports • Author/review and strategize safety sections of new drug applications and associated documents and other regulatory filings • Serve as safety expert on Evidence Generation Team for assigned products

Job Requirements

  • Doctorate degree and 4 years Safety experience OR Master’s degree and 7 years Safety experience OR Bachelor’s degree and 9 years Safety experience
  • Product safety in the bio/pharmaceutical industry or regulatory agency
  • Expertise in Obesity, Metabolic/CV therapeutic area, or clinical training.
  • Experience with marketed product safety; risk management
  • Experience with phase 1-3 clinical trials safety assessments and analyses
  • Drug Submission experience (preferably multiple new drug submission experience) and regulatory interactions
  • Leadership experience of 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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