Global Patient Safety Standards & Training Director

BioSpace; Dublin (OH); Hybrid; USD 102,000 - 165,000; Full time

Job summary

Regeneron is seeking an Associate Director for Global Patient Safety Standards & Training, based in Dublin. The role leads PV procedure design, updates, and alignment with regulatory requirements, collaborating with P&P and LCoE to sustain audit-ready systems and a robust GPS training program.

The position supports CAPA management, KPI reporting, and escalation of non-compliance issues, driving process enhancements across GPS and related functions worldwide.

Qualifications

• Minimum Bachelor's degree is required. Education in the life sciences is a strong plus.
• 7+ years' experience of Pharmacovigilance/Drug Safety, Regulatory Affairs or Quality Assurance in the pharmaceutical/biotech industry.
• Thorough understanding of Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems.
• Extensive experience managing procedural updates.
• Experience in PV process design and optimization.
• Track record of successful project management relevant to document management.
• Strong organizational skills.
• Ability to write procedural documents to accepted standards of quality.
• Experience presenting in audits and inspections.
• Ability to work collaboratively across functions with SMEs, process owners and cross-functional partners.
• Experience with Data Privacy is a plus

Responsibilities

• (Not provided in the HTML)

Skills

Strong organizational skills

Cross-functional collaboration

Project management

Procedural documentation

Education

Bachelor's degree

Job description

Regeneron is seeking an Associate Director for Global Patient Safety Standards & Training, based in Dublin. The role leads PV procedure design, updates, and alignment with regulatory requirements, collaborating with P&P and LCoE to sustain audit-ready systems and a robust GPS training program.

The position supports CAPA management, KPI reporting, and escalation of non-compliance issues, driving process enhancements across GPS and related functions worldwide.