Global Safety Senior Director, Pv Scientist- Obesity

Amgen

Remote
Base: 229,628.00 usd - 274,119.00 usd; bonus/equit...
Strategic oversight of safety submissions
Benefit/risk management process
Product safety profile evaluation
Provide strategic oversight and direction for all major regulatory safety submissions and responses or strategic deliverables including but not exclusive to Safety sections of NDA submissions, clinical overview, RMPs, PSURs, PBRERs, DSURs, DILs

Job Summary

  • Provide strategic oversight and direction for all major regulatory safety submissions and responses or strategic deliverables including but not exclusive to Safety sections of NDA submissions, clinical overview, RMPs, PSURs, PBRERs, DSURs, DILs.
  • Accountable for the Development and maintenance of core reference safety information (e.g., Development Core Safety Information [DCSI], Core safety information portions of Core Data Sheet [CDS]).
  • Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.

Matching Summary

Provide strategic oversight and direction for all major regulatory safety submissions and responses or strategic deliverables including but not exclusive to Safety sections of NDA submissions, clinical overview, RMPs, PSURs, PBRERs, DSURs, DILs.

Salary

Base: 229,628.00 USD - 274,119.00 USD; Bonus/Equity: Discretionary annual bonus program, Stock-based long-term incentives; Benefits: Comprehensive employee benefits package, Retirement and Savings Plan, group medical, dental and vision coverage, life and disability insurance, flexible spending accounts

Skills & Requirements

Must-have

  • Strategic oversight of safety submissions
  • Benefit/Risk Management Process
  • Product safety profile evaluation
  • Signal detection strategy
  • Risk management plan development
  • Periodic safety report preparation

Nice-to-have

  • Collaborative and innovative culture
  • Passion for challenges
  • Science-based approach
  • Patient-centric focus

Key Requirements

  • Doctorate degree and 5 years global safety experience
  • Master’s degree and 9 years global safety experience
  • Bachelor’s degree and 11 years global safety experience
  • 5 years managing people or leading teams

Work Rights

Not specified

Tailored Resume

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