Associate Director Civil Structural Engineer at AtkinsRéalis leading complex civil structural design for UK infrastructure. Collaborating with a multidisciplinary team on innovative projects in energy, defence, and nuclear sectors.
About the role
- Director of Global Patient Safety for Neurology leading safety strategies for assigned compounds at Regeneron. Overseeing safety activities and collaborating with stakeholders in a leading biotech company.
Responsibilities
- Serves as the first point of contact for all safety related issues for the compound(s)
- Leads safety strategy and ensures optimal support from within GPS
- Works collaboratively with stakeholders to deliver the safety strategy
- Responsible for all aspects of Global Patient Safety activities for assigned compounds and products in support of safety surveillance, signal management
- Represents Global Patient Safety on cross-functional teams, including Regeneron’s Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), Strategic Program Team (SPT)
- Proactively identifies and develops safety strategies and planning for non-compound specific Global Patient Safety activities
- Act as a resource for medical review for complex ICSRs and other data sources of assigned compounds
- Actively participate in development and maintenance of relevant SOPs, working practices and guides
- Participate in continuous improvement activities within both the TA and GPS organization
Requirements
- Minimum 10+ years of total relevant experience in PV and/or relevant medical field or equivalent of industry experience in drug safety including significant experience with PSURs/ DSURs/(d) RMPS; or in clinical development with demonstrated achievements in safety (ex. supporting an ISS; responsible for CSR content)
- 5+ years of total relevant experience in PV and/or relevant medical field with PharmD / PhD / MD degree required.
- Clinical experience and/or industry experience in Oncology is a plus
Benefits
- Health and wellness programs (including medical, dental, vision, life, and disability insurance)
- Fitness centers
- 401(k) company match
- Family support benefits
- Equity awards
- Annual bonuses
- Paid time off
- Paid leaves (e.g., military and parental leave)
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