Head of Pharmacovigilance Ops, Americas

Scorpion Therapeutics

Cambridge (MA)

On-site

USD 180,000 - 250,000

Full time

6 days ago
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Job summary

Regeneron Pharmaceuticals seeks an experienced Pharmacovigilance leader to oversee PV operations at regional levels, ensuring adherence to local regulations and seamless integration with global PV frameworks. The role emphasizes inspections readiness, risk management, and continuous process improvements, including exploring AI-enabled PV enhancements.

The ideal candidate has 12+ years in PV with a proven track record in patient safety, plus experience supporting regulatory inspections across

Qualifications

  • Bachelor’s degree (advanced preferred) in life sciences or related field.
  • 12+ years of PV experience with demonstrated patient safety achievements.
  • Experience supporting regulatory inspections and audits at regional or country level.
  • Preferred experience with AI technologies in PV.
  • Experience working across LATAM, US, and Canadian markets.

Responsibilities

  • Lead and oversee PV operations at regional or country levels within Regeneron's global patient safety framework.
  • Ensure compliance with local regulations and integration into global PV systems.
  • Support regulatory inspections and audits and drive continuous process improvements.
  • Monitor local legislation, track risk, and develop PV processes.
  • Coordinate cross-functionally with global teams, Medical Affairs, and Regulatory.
  • Lead, coach, and scale a PV team.

Skills

Leadership
Regulatory knowledge
PV operations
Audits & inspections
Cross-functional teamwork
AI in PV

Education

Bachelor's degree
Advanced degree preferred

Job description

Regeneron Pharmaceuticals seeks an experienced Pharmacovigilance leader to oversee PV operations at regional levels, ensuring adherence to local regulations and seamless integration with global PV frameworks. The role emphasizes inspections readiness, risk management, and continuous process improvements, including exploring AI-enabled PV enhancements.

The ideal candidate has 12+ years in PV with a proven track record in patient safety, plus experience supporting regulatory inspections across

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