Global Patient Safety Scientist Manager

Regeneron Pharmaceuticals, Inc.; New Jersey; On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Paid time off

Life insurance

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Manager to join the Global Patient Safety Sciences (GPS) team.

The role provides scientific leadership in safety strategies for molecules in clinical development and post-marketing, including safety data aggregation, review, and interpretation for benefit-risk assessment. This position offers on-site work four days per week with 25% travel, and opportunities to contribute to safety surveillance, DSUR/PSUR/RMP preparation, and cross-functional

Qualifications

• 5+ years of risk management or relevant clinical experience in pharmaceutical/biotech industry or health authority.
• Ability to apply FDA, EU and ICH guidelines governing pharmacovigilance for clinical trials and post-marketing environments.
• Experience preparing safety documents (DSUR, PSUR, RMP) and safety reports.
• Experience with data manipulation and visualization for safety analysis.
• Excellent written and verbal communication skills for cross-functional collaboration.

Responsibilities

• Complete signal detection activities per safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Prepare and review DSUR, PSUR, and RMP; respond to health authority queries.
• Prepare and deliver presentations at SMT meetings; participate in study team meetings.
• Represent GPS on cross-functional teams (RSOC, IDMC) and other groups.
• Utilize data tools (Excel, Pivot tables) for safety analyses; drive process improvements.

Skills

Signal detection

Signal evaluation

Safety data analysis

Data presentation

Communication skills

Tools

Excel

Pivot tables

Safety database

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Manager to join the Global Patient Safety Sciences (GPS) team.

The role provides scientific leadership in safety strategies for molecules in clinical development and post-marketing, including safety data aggregation, review, and interpretation for benefit-risk assessment. This position offers on-site work four days per week with 25% travel, and opportunities to contribute to safety surveillance, DSUR/PSUR/RMP preparation, and cross-functional