Global Patient Safety Sciences Lead

Regeneron Pharmaceuticals, Inc.; Village of Tarrytown (NY); Hybrid; USD 176,000 - 287,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Pension plan

401(k) match

Health benefits

Wellness programs

Paid time off

Family support

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director for Global Patient Safety Sciences in a hybrid role. You will lead safety surveillance, signal evaluation and benefit-risk assessments, collaborating with clinical study teams and safety committees.

Responsibilities include DSUR/PSUR/RMP management, presenting at meetings, and maintaining safety SOPs to strengthen processes across GPS. This is a senior function in a science-driven organization.

Qualifications

• Master’s degree, PhD or PharmD required.
• 10+ years of relevant pharmaceutical/biotech/health authority experience preferred.
• Experience in risk management or pharmacovigilance.
• Knowledge of FDA/EU/ICH pharmacovigilance requirements.
• Experience using safety databases for medical case review.

Responsibilities

• Lead safety surveillance, signal evaluation and benefit-risk assessments.
• Maintain and manage safety documents (DSURs, PSURs, RMPs and safety responses).
• Present at Signal Management Team meetings and support clinical study teams.
• Represent GPS on cross-functional safety committees and external monitoring committees.
• Strengthen safety processes by updating SOPs and work instructions.

Skills

Safety surveillance

Signal detection

Safety evaluation reports

Regulatory pharmacovigilance

FDA/EU/ICH knowledge

Safety databases

Clear safety communication

Education

Master’s degree

PhD

PharmD

Tools

Safety databases

Job description

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director for Global Patient Safety Sciences in a hybrid role. You will lead safety surveillance, signal evaluation and benefit-risk assessments, collaborating with clinical study teams and safety committees.

Responsibilities include DSUR/PSUR/RMP management, presenting at meetings, and maintaining safety SOPs to strengthen processes across GPS. This is a senior function in a science-driven organization.