Senior Manager, Global Patient Safety - General Medicine

Discover Your Role:

• Complete signal detection activities in line with approved safety surveillance plan
• Perform signal evaluation for any identified signals and author safety evaluation reports
• Manage preparation and review of safety documents including DSUR, PSUR, RMP, and responses to health authority or other queries
• Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds
• Participate in other risk management activities as appropriate for assigned compounds
• Represent GPS on cross-functional teams, including RSOC and IDMC, and other teams with external members
• Participate in process improvement initiatives (development/maintenance of relevant SOPs, WIs, and supporting documents)

• Minimum a Master’s, PhD, or PharmD
• 7+ years of relevant risk management experience in pharmaceutical/biotech industry or with a health authority
• Ability to apply relevant FDA, EU, and ICH guidelines/initiatives/regulations for pharmacovigilance in clinical trial and post-marketing settings
• Ability to work with a safety system database for medical case review and simple queries
• Proactive, self-disciplined; able to meet deliverables and prioritize effectively
• Ability to effectively communicate (verbal and written) safety findings

• Work location:
  
  Tarrytown, NY or Warren, NJ
• 4 days per week on site