Global Safety Program Lead

AstraZeneca

Gothenburg, Sweden
Safety strategy and delivery
Pharmacovigilance standards and processes
Global regulatory submissions
The Global Safety Program Lead, Senior Director is accountable to the Global Safety Head for the safety strategy, delivery, and oversight of the assigned asset(s)

Job Summary

  • The Global Safety Program Lead, Senior Director is accountable to the Global Safety Head for the safety strategy, delivery, and oversight of the assigned asset(s).
  • Accountable for the quality of key safety deliverables e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs), compliance and adherence to PV regulations of the assigned asset(s).
  • Line manages a team of safety physicians and / or scientists.

Matching Summary

The Global Safety Program Lead, Senior Director is accountable to the Global Safety Head for the safety strategy, delivery, and oversight of the assigned asset(s).

Skills & Requirements

Must-have

  • safety strategy and delivery
  • pharmacovigilance standards and processes
  • global regulatory submissions
  • lead safety physicians and scientists
  • risk management plans

Nice-to-have

  • cross-functional collaboration
  • solutions-oriented team actions
  • independent judgment
  • industry conference speaking experience

Key Requirements

  • Medical degree or equivalent
  • 5 years extensive clinical, safety experience
  • Proven track record of successful clinical safety delivery
  • Ability to collaborate across a matrixed environment
  • Thorough knowledge of pharmacovigilance
  • Experience of global regulatory submissions
  • Demonstrated ability to lead, coach, mentor

Work Rights

Not specified

Tailored Resume

Cover Letter