Global Patient Safety Senior Manager – Onsite 4 Days/Week

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

Job summary

Regeneron seeks a Senior Manager to join Global Patient Safety (GPS). You will shape safety strategies for clinical and post-marketing programs, linking safety data aggregation with interpretation and benefit-risk assessment.

Location options include Tarrytown, NY or Warren, NJ, with four on-site days per week. You will drive signal detection/evaluation, DSUR/PSUR/RMP processes, and present at SMT meetings, working with RSOC, IDMC, and other teams.

Qualifications

• Minimum a Master’s, PhD, or PharmD.
• 7+ years of relevant risk management experience in pharma/biotech or health authority.
• Ability to apply FDA, EU and ICH guidelines governing pharmacovigilance.

Responsibilities

• Complete signal detection activities aligned with the safety surveillance plan.
• Perform signal evaluation and author the safety evaluation reports.
• Manage preparation and review of safety documents (DSUR, PSUR, RMP) and respond to health authority queries.
• Prepare and deliver presentations at SMT meetings and participate in study teams for assigned compounds.
• Represent GPS on cross-functional teams such as RSOC and IDMC; contribute to process improvements.

Skills

Risk management experience

FDA/ICH guidelines knowledge

Safety communications

Self-discipline / time management

Education

Master's/PhD/PharmD

Job description

Regeneron seeks a Senior Manager to join Global Patient Safety (GPS). You will shape safety strategies for clinical and post-marketing programs, linking safety data aggregation with interpretation and benefit-risk assessment.

Location options include Tarrytown, NY or Warren, NJ, with four on-site days per week. You will drive signal detection/evaluation, DSUR/PSUR/RMP processes, and present at SMT meetings, working with RSOC, IDMC, and other teams.