Director, Pharmacovigilance Hub - Americas

Scorpion Therapeutics; Cambridge (MA); On-site; USD 180,000 - 250,000; Full time

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

Role

Lead and oversee Pharmacovigilance (PV) operations at regional or country levels within Regeneron's global patient safety framework, ensuring compliance with local regulations and integration into global PV systems. Objectives include maintaining high-quality safety data collection, supporting inspections and audits, and driving continuous process improvements, including leveraging emerging technologies like AI.

Responsibilities encompass local legislation monitoring, risk tracking, process development, compliance management, and cross-functional coordination with global teams, Med Affairs, and Regulatory. Leading, coaching, and scaling a PV team is also key.

Qualifications include a Bachelor’s degree (advanced preferred), 12+ years of PV experience with demonstrated patient safety achievements, and experience supporting regulatory inspections and audits at the regional or country level. Preferred experience with AI technologies and working within LATAM, US, and Canadian markets enhances candidacy. The role demands strong organizational and communication skills, with a focus on early risk identification and resolution through global governance channels.

Work is primarily onsite (Tarrytown, NY; Cambridge, MA; Warren, NJ) with 4 days/week onsite requirement; travel details are not specified but likely minimal given regional oversight duties.