Global Patient Safety Senior Manager — Signal & Risk

BioSpace; New Jersey; On-site; USD 151,000 - 246,000; Full time

Job summary

Regeneron is seeking a Senior Manager to join the Global Patient Safety (GPS) team. You will lead safety strategies for molecules in clinical development and post-marketing, aggregating and analyzing safety data to support interpretation and benefit-risk assessment.

Location includes on-site work in NY/NJ with 4 days on-site per week. The role requires a Master’s, PhD, or PharmD and 7+ years in pharmacovigilance, with expertise in FDA/EU/ICH guidelines, safety databases, and risk management.

Qualifications

• Master's, PhD, or PharmD required.
• 7+ years of relevant risk management experience.
• Ability to apply FDA/EU/ICH pharmacovigilance guidelines.

Responsibilities

• Perform signal detection activities per safety surveillance plan.
• Evaluate identified signals and author safety evaluation reports.
• Prepare/review safety documents: DSUR, PSUR, RMP.
• Deliver presentations at SMT meetings; join clinical study team meetings.
• Participate in risk management activities for assigned compounds.
• Represent GPS on cross-functional teams (RSOC, IDMC).
• Contribute to SOPs, WIs, and related documentation.

Skills

Signal detection

Signal evaluation

Safety reporting

Documentation

Presentations

Cross-functional teamwork

Risk management

Process improvement

Education

Master's degree

PhD

PharmD

Job description

Regeneron is seeking a Senior Manager to join the Global Patient Safety (GPS) team. You will lead safety strategies for molecules in clinical development and post-marketing, aggregating and analyzing safety data to support interpretation and benefit-risk assessment.

Location includes on-site work in NY/NJ with 4 days on-site per week. The role requires a Master’s, PhD, or PharmD and 7+ years in pharmacovigilance, with expertise in FDA/EU/ICH guidelines, safety databases, and risk management.