Global Patient Safety Manager: Signal & Risk Analytics

Regeneron Pharmaceuticals; Tarrytown (GA); On-site; USD 115,000 - 187,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Manager to join Global Patient Safety Sciences. You will lead safety strategies for molecules in development and post-marketing, including signal detection, evaluation, and safety documentation such as DSUR, PSUR, and RMP.

You will present at SMT meetings and may engage with RSOC, IDMC, and other cross-functional teams. This role requires a Master’s/PharmD/PhD with 5+ years in pharmacovigilance or related clinical experience, leveraging FDA/EU/ICH

Qualifications

• Minimum Master degree, PharmD, PhD.
• 5+ years of risk management or relevant clinical experience in pharmaceutical/ biotech industry or health authority.
• Clinical experience and/or Industry experience in the TA of interest is a plus.

Responsibilities

• Complete signal detection activities.
• Perform signal evaluation and author safety evaluation reports.
• Manage preparation and review of safety documents (DSUR, PSUR, RMP).
• Prepare and deliver presentations at SMT meetings.
• Represent GPS on cross-functional teams (RSOC, IDMC).
• Contribute to process improvement and SOP development.

Skills

Data analysis

Excel

PIVOT tables

Verbal communication

Education

Master degree

PharmD

PhD

Tools

Safety system database

Job description

Regeneron Pharmaceuticals is seeking a Manager to join Global Patient Safety Sciences. You will lead safety strategies for molecules in development and post-marketing, including signal detection, evaluation, and safety documentation such as DSUR, PSUR, and RMP.

You will present at SMT meetings and may engage with RSOC, IDMC, and other cross-functional teams. This role requires a Master’s/PharmD/PhD with 5+ years in pharmacovigilance or related clinical experience, leveraging FDA/EU/ICH