Regeneron
Pharma
Director,GlobalPatientSafetySciences
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“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
Full Job Description
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a **Director** to join our **Patient Safety** team. The Global Patient Safety (GPS) Lead role (Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s)/asset(s) assigned within a given therapeutic area (TA), and is the GPS representative on the cross functional strategic program team (SPT) for the compound. The GPS Lead leads the safety strategy and ensures the optimal support from within GPS and works collaboratively with stakeholders to deliver the safety strategy. This position requires the ability to work with and influence colleagues in a matrix environment within and external to GPS including senior management. The GPS Director joins Regeneron’s industry leading scientific organization, and has a direct impact on drug development, operations, and commercialization in all relevant global territories. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. **When & where:** * Work Location: Tarrytown, NY or Warren, NJ * Hybrid; 4 days per week on site **Discover your role:** * This Director position is directly responsible for all aspects of Global Patient Safety activities for assigned compounds and products in support of safety surveillance, signal management, communication of the safety profile as appropriate for the stage in the asset lifecycle, benefit risk assessment, safety responses to regulatory agency queries, safety documents (DSURs, PSURs, development RMPs, RMPs, etc.) and the review of clinical documents (Investigator Brochures, protocols, clinical study reports, etc.) * Leads cross-functional Safety Monitoring Team (SMT) activities * Represent Global Patient Safety for assigned compounds on cross-functional teams, including Regeneron’s Safety Oversight Committee (RSOC), Indepe
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