Senior Manager, Global Patient Safety — Oncology Impact

BioSpace; Cambridge (MA); On-site; USD 151,000 - 246,000; Full time

Job summary

Regeneron seeks a Senior Manager for Global Patient Safety to shape safety strategies for molecules in development and post-marketing. You will aggregate and analyze safety data, support benefit-risk assessment, and lead communications for safety findings.

Role is on-site in the US with responsibilities spanning signal management, risk assessment, and cross-functional collaboration to ensure regulatory compliance and high safety standards.

Qualifications

• Minimum a Master's, PhD, or PharmD.
• Experience in pharmacovigilance within pharma/biotech or health authority is required.
• Ability to apply FDA, EU and ICH safety guidelines.

Responsibilities

• Complete signal detection activities in line with approved safety surveillance plan
• Perform signal evaluation for identified signals and author safety evaluation reports
• Manage preparation and review of safety documents including DSUR, PSUR, RMP, and regulatory queries
• Prepare and deliver presentations at Signal Management Team meetings and clinical study teams
• Participate in other risk management activities for assigned compounds
• Represent GPS on cross-functional teams (RSOC, IDMC) and external committees
• Contribute to process improvement with SOPs, WIs, and supporting documents

Skills

Signal detection

Signal evaluation

Safety reports

Regulatory compliance

Presentation skills

Cross-functional teamwork

Pharmacovigilance

Education

Master's

PhD

PharmD

Tools

Safety system database

Job description

Regeneron seeks a Senior Manager for Global Patient Safety to shape safety strategies for molecules in development and post-marketing. You will aggregate and analyze safety data, support benefit-risk assessment, and lead communications for safety findings.

Role is on-site in the US with responsibilities spanning signal management, risk assessment, and cross-functional collaboration to ensure regulatory compliance and high safety standards.