Global Patient Safety Leader—Oncology

BioSpace

New Jersey

Hybrid

USD 205,000 - 342,000

Full time

3 days ago
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Job summary

Regeneron is seeking a Director for Global Patient Safety to lead safety strategy across assigned assets. The role interfaces with SMTs, RSOC/IDMC and cross-functional teams to ensure proactive safety planning and regulatory readiness.

The position requires extensive PV experience (PharmD/PhD/MD) and a track record in DSURs/PSURs, with leadership of diverse teams and strong scientific communication. Hybrid on-site work is expected in the US.

Qualifications

  • Minimum 10+ years of total relevant experience in PV or pharmacovigilance.
  • 5+ years of PV experience with PharmD/PhD/MD required.
  • Experience with PSURs/DSURs and regulatory submissions preferred.

Responsibilities

  • Lead GPS safety strategy and cross-functional SMT activities.
  • Represent GPS on cross-functional teams including RSOC/IDMC.
  • Develop safety plans for compounds across asset lifecycle.
  • Mentor junior safety scientists and improve SOPs.

Skills

Leadership
Cross-functional collaboration
Pharmacovigilance
Safety case review
Regulatory knowledge
Scientific writing

Education

PharmD / PhD / MD degree

Job description

Regeneron is seeking a Director for Global Patient Safety to lead safety strategy across assigned assets. The role interfaces with SMTs, RSOC/IDMC and cross-functional teams to ensure proactive safety planning and regulatory readiness.

The position requires extensive PV experience (PharmD/PhD/MD) and a track record in DSURs/PSURs, with leadership of diverse teams and strong scientific communication. Hybrid on-site work is expected in the US.

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