Global Patient Safety Standards & Training Lead

BioSpace; Dublin (OH); Hybrid; USD 114.000 - 185.000; Vollzeit

Zusammenfassung

Regeneron seeks an Associate Director to join Global Patient Safety Standards & Training. You will establish procedures aligning PV regulations with industry practices and coordinate with P&P and LCoE to ensure training reflects updates.

The role requires PV/Drug Safety expertise, a life sciences degree, and 7+ years in pharma/biotech quality systems. Onsite Dublin with partial on-site work and travel considerations are expected.

Qualifikationen

• Bachelor's degree in life sciences required; relevant experience preferred.
• 7+ years' Pharmacovigilance/Drug Safety, Regulatory Affairs or Quality Assurance in pharma/biotech.
• Strong understanding of PV regulations and PV Quality Management Systems.

Aufgaben

• Update GPS procedures to reflect PV regulatory expectations and maintain audit readiness.
• Coordinate with P&P and LCoE to capture procedural changes in training curricula.
• Validate procedures for fit-for-purpose safety practices and map documents to regulations and training.
• Develop and maintain GPS procedures aligned with regulations and industry best practices.
• Lead assessment of evolving global PV regulations and prioritize procedural updates.

Kenntnisse

Pharmacovigilance

Regulatory affairs

Quality assurance

Ausbildung

Bachelor's degree in life sciences

Jobbeschreibung

Regeneron seeks an Associate Director to join Global Patient Safety Standards & Training. You will establish procedures aligning PV regulations with industry practices and coordinate with P&P and LCoE to ensure training reflects updates.

The role requires PV/Drug Safety expertise, a life sciences degree, and 7+ years in pharma/biotech quality systems. Onsite Dublin with partial on-site work and travel considerations are expected.