Global Patient Safety Standards & Training Lead

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

Job summary

Regeneron Pharmaceuticals in Dublin, Ireland seeks an Associate Director to join Global Patient Safety Standards & Training. You will establish and maintain PV procedures, ensure alignment with regulations, and collaborate across P&P, LCoE, and PONs to keep training curricula current.

The role emphasizes PV process design, audit readiness, and driving continuous improvements with senior stakeholders. On-site work 3 days per week, with travel up to 25%.

Qualifications

• Minimum Bachelor’s degree; life sciences is a strong plus.
• 7+ years’ experience of Pharmacovigilance/Drug Safety, Regulatory Affairs or Quality Assurance in pharma/biotech.
• 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

• Ensure that PV Intelligence updates are reflected in GPS procedures and that documented processes remain audit-ready.
• Act as a key liaison to P&P and LCoE for procedural updates, ensuring proper sequencing and integration with training curriculum.
• As an SME, validate procedures against safety practices and map to regulations and the training curriculum.
• Apply deep PV process design expertise to develop, implement, and maintain GPS procedures in alignment with regs, Regeneron Standards, and industry best practices.
• Lead the assessment of evolving global PV regulations with P&P, Process Owners, and SMEs.
• Set risk-based prioritization and sequencing for procedural updates with PONs and GPS Leads.
• Assist in ensuring the correct procedural documents are assigned to the relevant training curriculum.
• Maintain oversight of GPS Planned Process Deviations (PPDs) and guide CAPA criteria for GDQ.
• Coordinate PPD expiration dates with queued procedure projects and adjust priorities as needed.
• Serve as GPS escalation point for internal process and quality-event alignment challenges.
• Manage CAPAs with SMEs and PONs, ensuring timely closure and related training.
• Provide regular metrics on CAPAs, deviations, and training compliance to GPS leadership.
• Lead initiatives to enhance GPS process effectiveness and present findings to leadership.
• Liaise with Corporate and Clinical QA on potential impacts to GPS processes or GXP activities.
• Represent Standards & Training in audits and inspections.
• Serve as back-up GPS Standards & Training liaison to LCoE.

Skills

Pharmacovigilance

Regulatory Affairs

Quality Assurance

Procedural updates

PV process design

Project management

Education

Bachelor's degree

Job description

Regeneron Pharmaceuticals in Dublin, Ireland seeks an Associate Director to join Global Patient Safety Standards & Training. You will establish and maintain PV procedures, ensure alignment with regulations, and collaborate across P&P, LCoE, and PONs to keep training curricula current.

The role emphasizes PV process design, audit readiness, and driving continuous improvements with senior stakeholders. On-site work 3 days per week, with travel up to 25%.