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Senior Director of Safety and Pharmacovigilance

2 months ago

Reston, Virginia, United States Milestone Technologies, Inc. Full time
Job Summary

Milestone Technologies, Inc. is seeking a highly experienced and skilled Vice President of Global Safety and Pharmacovigilance to lead our safety and pharmacovigilance efforts across all compounds. The successful candidate will oversee all aspects of clinical and commercial drug safety and safety operations, working closely with cross-functional teams and external experts.

Key Responsibilities
  • Lead medical safety aspects of clinical development and post-market surveillance of medicinal products in our portfolio
  • Strategically oversee safety and pharmacovigilance operations across clinical and commercial compounds
  • Manage vendor deliverables and measurements associated with safety and PV for clinical programs and approved products
  • Partner with clinical development representatives to lead safety signal assessments and validate safety signals
  • Oversee Drug Safety Committees and Core Safety Information
  • Contribute written summaries and provide safety review for safety components of protocols, IB, clinical study reports, regulatory submissions, and label negotiations
  • Ensure compliance with global safety requirements and inspection readiness
Requirements
  • MD or PharmD with relevant safety and PV experience in biotechnology or pharmaceutical industry, plus 10+ years of industry experience
  • Experience in building teams, directly or matrixed, and leading projects
  • Robust knowledge of global PV requirements
  • Experience overseeing safety/PV vendors
  • Ability to provide robust safety strategies at the highest level and perform detailed work to support Phase 1-3 programs and commercial products
What We Offer

The estimated pay range for this position is USD $375,000 - $400,000/Yr. and is an Exempt role. Exact compensation and offers of employment are dependent on circumstances of each case and will be determined based on job-related knowledge, skills, experience, licenses or certifications, and location.