Regeneron
Pharma
Director,GlobalPatientSafetySciences
“Director, Global Patient Safety Sciences at Regeneron. Skills: Patient Safety, Drug development, Regulatory compliance. Lead safety strategy. Ensure optimal support from GPS”
What You'll Achieve.
Deliver safety strategy
Industry & Context.
Critical analysis
4 days per week on site
What They're Looking For.
Must Have
10+ years experience in PV, 5+ years experience in PV, PharmD / PhD / MD degree, Clinical experience in Oncology, Industry experience in Oncology
Nice to Have
Experience with PSURs/DSURs, Experience supporting CSR content
What You'll Do.
Ensure optimal support from GPS
Deliver safety strategy
Manage all aspects of Global Patient Safety
Support safety surveillance
Support signal management
Communicate safety profile
Support benefit risk assessment
Provide safety responses
Prepare safety documents
Review clinical documents
Lead Safety Monitoring Team activities
Represent Global Patient Safety
Identify safety strategies
Develop safety strategies
Plan Global Patient Safety activities
Provide medical review
Develop relevant SOPs
Maintain relevant SOPs
Participate in continuous improvement
Cultivate cross functional relationships
Mentor junior safety scientists
Provide critical analysis
Function as subject matter expert
Communicate safety viewpoints
Communicate safety findings
Recommend risk management
Recommend minimization activities
Utilize GPS safety database
Perform medical case review
Perform simple queries
How You'll Work.
Team & Collaboration
Cross functional teams; Senior management; Alliance partners; CROs
Communication Scope
Safety viewpoints; Safety findings
Process & Methodology
Program team
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