Global Patient Safety Science Lead

Regulatory Jobs; New Jersey; On-site; USD 115,000 - 187,000; Full time

Job summary

Regeneron is seeking a Manager to join the Global Patient Safety Sciences team to lead safety strategies for molecules in clinical development and post-marketing phases. The role involves safety data aggregation, review, and analysis to support safety interpretation and benefit-risk assessment.

Location options include Sleepy Hollow, NY, Warren, NJ, or Cambridge, MA with 4 days on site per week and up to 25% travel.

Qualifications

• Significant safety or clinical experience in pharma/biotech, 5+ years.
• Experience with pharmacovigilance and regulatory guidelines (FDA, EU, ICH).
• Ability to manipulate safety data and produce DSUR/PSUR/RMP documents.

Responsibilities

• Perform signal detection and evaluation for safety data.
• Prepare DSUR, PSUR, and RMP documents.
• Prepare and deliver safety presentations for SMT and clinical study teams.
• Participate in risk management activities for assigned compounds.
• Represent GPS on cross-functional teams as needed.

Skills

Data visualization

Communication skills

Safety data interpretation

Cross-functional collaboration

Education

Master degree

PharmD

PhD

Tools

Safety database

Job description

Regeneron is seeking a Manager to join the Global Patient Safety Sciences team to lead safety strategies for molecules in clinical development and post-marketing phases. The role involves safety data aggregation, review, and analysis to support safety interpretation and benefit-risk assessment.

Location options include Sleepy Hollow, NY, Warren, NJ, or Cambridge, MA with 4 days on site per week and up to 25% travel.