Global Patient Safety Standards & Training Lead

Regeneron Pharmaceuticals, Inc; New Jersey; On-site; USD 157,000 - 257,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to lead Global Patient Safety Standards & Training, shaping GPS procedures and ensuring alignment with PV regulations worldwide.

You will collaborate with P&P, LCoE, and SMEs to map procedures to training curricula and drive continuous improvement across the GPS framework. Ideal candidates have 7+ years in Pharmacovigilance or related fields, strong project management experience, and a proven ability to write quality procedural

Qualifications

• Minimum Bachelor's degree is required; life sciences is a strong plus.
• 7+ years' experience in Pharmacovigilance/Drug Safety, Regulatory Affairs or Quality Assurance.
• 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 related to document management.
• Strong organizational skills.

Responsibilities

• Ensure PV Intelligence updates are systematically assessed and reflected in GPS procedures.
• Act as a key liaison to P&P and LCoE for procedural updates and training curriculum alignment.
• As an SME, validate procedures against safety practices and regulatory requirements.
• Apply PV process design expertise to develop and maintain GPS procedures aligned with regulations.
• Set risk-based prioritization and sequencing of procedural updates across the GPS framework.
• Assist in assigning procedural documents to the relevant training curriculum.
• Maintain oversight of GPS Planned Process Deviations (PPDs) and GDQ criteria.
• Coordinate with P&P to align PPD expiration dates with project timelines.
• Serve as escalation point for process and quality-event alignment challenges.
• Manage GPS procedure content with Process Owners and SMEs; monitor CAPA status.
• Provide regular metrics on CAPAs, deviations, and training compliance to 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.
• Represent Standards & Training in audits and inspections; back-up to LCoE.

Skills

Pharmacovigilance/Drug Safety

Strong organizational skills

Ability to write procedural documents

Experience presenting in audits and in

Education

Bachelor's degree (life sciences a strong plus)

Job description

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to lead Global Patient Safety Standards & Training, shaping GPS procedures and ensuring alignment with PV regulations worldwide.

You will collaborate with P&P, LCoE, and SMEs to map procedures to training curricula and drive continuous improvement across the GPS framework. Ideal candidates have 7+ years in Pharmacovigilance or related fields, strong project management experience, and a proven ability to write quality procedural