Reporting to the Head of Global Patient Safety (GPS) Standards & Training, this position is responsible for establishing and maintaining procedures and policies consistent with Pharmacovigilance regulatory requirements and industry standards. A key part of the role is close collaboration with the Process and Procedures (P&P) team and support of the Process Owner Network (PONs). The responsibilities of this job are foundational in the creation and maintenance of the Pharmacovigilance (PV) System that is essential in enabling the department, and therefore the company, to comply with regulatory PV requirements in all relevant territories worldwide, and to operate efficiently and effectively in alignment with established industry practices. The role supports GPS activities and ensures procedures remain compliant with applicable global regulations as they evolve.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Work Location: Sleepy Hollow, NY, Warren, NJ or Cambridge, MA
• 4 days per week on site
• 25% Travel may be required

Discover your role:

• Ensure that PV Intelligence updates are systematically assessed and reflected in GPS procedures, so that documented processes remain aligned with current regulatory expectations and the procedural framework is maintained in a state of audit and inspection readiness at all times.
• Act as a key liaison to Process & Procedures (P&P) and the Learning Centre of Excellence (LCoE) for procedural updates, so that procedural changes are accurately captured, appropriately sequenced, and correctly reflected in the associated training curriculum.
• As an SME, partner with the Head of GPS Safety Operations to validate that procedures are fit for purpose against safety practices, closing gaps between documented process and operational execution, including the mapping of procedural documents to regulations and to the training curriculum.
• Apply deep PV process design expertise to develop, implement, and maintain GPS procedures in alignment with regulations, Regeneron Standards, and industry best practices — in partnership with Process & Procedures (P&P), Process Owners, and SMEs — and lead the assessment of evolving global PV regulations.
• As a primary liaison to P&P, partner to set risk-based prioritization and sequencing in managing procedural updates across the GPS framework, in partnership with PONs and GPS Functional Leads.
• Assist in ensuring the correct procedural documents are assigned to the relevant training curriculum.
• Maintain oversight of and support for GPS Planned Process Deviations (PPDs), including guiding SMEs on meeting Global Development Quality (GDQ) approval criteria.
• Coordinate with P&P to align PPD expiration dates with queued procedure projects, adjusting prioritization as needed.
• Serve as GPS's escalation point for internal process and quality-event alignment challenges related to procedural updates, working in alignment with senior management and key stakeholders to investigate and resolve non-compliance.
• Manage, alongside the Process Owners, the content of procedures for GPS, escalating material gaps to senior management, including the maintenance and accuracy of PSMF Annex E in relation to GPS procedures.
• Maintain an overview of CAPAs associated with procedures, including those arising from both audits and inspections, and work closely with SMEs, PONs and the P&P team to ensure timely CAPA closure, including allowing appropriate time for associated training.
• Provide regular metrics on CAPAs, process deviations, and training compliance to GPS department leadership.
• Lead initiatives to enhance GPS process effectiveness and efficiency, including the analytical framework for performance metrics, and present findings and recommendations to leadership.
• Liaise regularly with other functional teams e.g. Corporate and Clinical QA on potential impacts to GPS Processes or GXP-related activities.
• Represent Standards & Training in audits and inspections.
• Serve as the back-up GPS Standards & Training liaison to LCoE.

This role requires:

• 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

Salary Range (annually)