Global PV Standards & Training Lead

Regeneron Pharmaceuticals, Inc; Dublin; On-site; EUR 102,000 - 165,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to lead Global Patient Safety Standards & Training.

The role focuses on establishing and maintaining PV procedures compliant with global regulations and industry standards, collaborating across P&P and LCoE to ensure training aligns with updated procedures. The position requires 7+ years in Pharmacovigilance/Drug Safety or related fields, a life sciences degree, and strong cross-functional collaboration skills.

Qualifications

• Minimum Bachelor's degree; life sciences preferred.
• 7+ years' experience in Pharmacovigilance/Drug Safety, Regulatory Affairs or Quality Assurance.
• Thorough understanding of Pharmacovigilance regulations and PV Quality Management Systems.
• Experience in PV process design and optimization.
• Experience managing procedural updates.
• Strong organizational skills and ability to write procedural documents.
• Experience presenting in audits and inspections.
• Ability to work with SMEs, process owners and cross-functional partners.
• Data privacy experience is a plus.

Responsibilities

• Establish and maintain GPS procedures compliant with regulations.
• Collaborate with P&P and LCoE for procedural updates.
• Validate procedures are fit-for-purpose against safety practices.
• Develop and maintain GPS procedures aligned with Regeneron standards.
• Lead in managing procedural updates across GPS framework.
• Provide regular metrics on CAPAs, deviations, and training compliance.
• Represent GPS Standards & Training in audits and inspections.

Skills

PV regulatory knowledge

Pharmacovigilance

Procedural updates management

Project management

Cross-functional collaboration

Regulatory compliance

Data privacy knowledge

Education

Bachelor's degree in life sciences

Job description

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to lead Global Patient Safety Standards & Training.

The role focuses on establishing and maintaining PV procedures compliant with global regulations and industry standards, collaborating across P&P and LCoE to ensure training aligns with updated procedures. The position requires 7+ years in Pharmacovigilance/Drug Safety or related fields, a life sciences degree, and strong cross-functional collaboration skills.