Manager, Global Patient Safety - QPPV Governance

Regeneron Pharmaceuticals•Tarrytown, GA

9d•$114,800 - $187,400•Hybrid

About The Position

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager to join our Patient Safety QPPV team. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. This position resides in the Global Patient Safety (GPS) organization of Regeneron within the QPPV Office functional area, and is responsible for supporting the strategic and operational needs of the EU & UK Qualified Person for Pharmacovigilance (EU QPPV). This position acts as a primary point of contact for coordinating and managing QPPV Office activities in order to meet team goals by developing, driving, and directing operational plans. In addition, the Mgr, QPPV Office Implementation Management will work with Subject Matter Experts within GPS and non-GPS functions, as appropriate. All activities within this role directly support the statutory QPPV function. This position sits within the QPPV Office and reports directly to the EU & UK QPPV.

Requirements

Masters or Doctoral degree (PhD, PharmD, MD) in a relevant field.
Industry/regulatory experience preferred.
Other post-graduate degree in a related field (e.g., MPH, MSc), generally with 7+ years of relevant experience.
Industry/regulatory experience preferred.
Demonstrated achievements of increasing complexity/responsibility.
Experience in pharmacovigilance and patient safety within a pharmaceutical or biotech environment
Demonstrable knowledge of GVP Modules I–XVI, EU pharmacovigilance legislation, and PSMF.
Excellent written and verbal communication skills; proven ability to work in a matrix organization; established project leadership skills, including problem solving and conflict management.
Proven track record of interpersonal, influencing, leadership, and project management skills.
Ability to enable decision making and assess situations in order to minimize risk, make timely and pragmatic decisions, and ability to work through ambiguity.
Experience in a QPPV Office, PV Quality, or Compliance function with exposure to EU regulatory inspections preferred.
Knowledge of US and international regulatory guidances and ability to apply this knowledge to pharmacovigilance activities.
Maintains high ethical standards, including a commitment to the Company’s values and behaviors.

Nice To Haves

Industry/regulatory experience preferred.
Experience in a QPPV Office, PV Quality, or Compliance function with exposure to EU regulatory inspections preferred.

Responsibilities

Provides tactical leadership, direction and support to QPPV Office activities, including oversight meetings, meetings with subject matter experts, PSMF-related activities, and compliance documentation (e.g. minutes, archiving, document retention).
Independently assesses the needs of the QPPV Office and establishes frameworks to ensure that regulatory requirements, internal obligations and inspection readiness is considered.
Ensures optimal structure, procedures, and adequate resources to support the QPPV Office’s effectiveness.
Knows when to escalate issues to EU & UK QPPV and, where appropriate, senior levels of management to obtain timely resolution.
Facilitates achievement of strategic goals for the QPPV Office.
Organizes, maintains, and operates the QPPV oversight framework, including oversight forums and cadence (e.g., QPPV monthly oversight meetings, QPPV Core weekly meetings, quarterly meetings with the LCPPV network, and cross-functional team meetings), in collaboration with the WWOO Director where relevant.
Manages meeting agendas, decision logs, rationale for escalations, and tracking of open actions.
Maintains QPPV delegation records and ensures evidence of QPPV authority and influence on the PV system are appropriately documented and archived.
Monitors the QPPV mailbox and ensures triage of communications to support QPPV awareness and timely action.
Ensures all QPPV meeting outputs are inspection-ready.
Ensures utilization of appropriate systems within Regeneron to optimize cross-functional communication, planning, and transparency.
Ensures adherence to all relevant policies, process and procedures.
Drives process improvements to ensure consistency, efficiency, and compliance.
Acts as a key liaison in the interactions between the QPPV Office and internal partners and, where appropriate, external vendors and collaborators.
Supports the EU & UK QPPV’s accountability for PSMF accuracy and integrity, including: supporting the PSMF coordinator role during PSMF updates; performing PSMF quality control as needed; supporting tasks related to PSMF process/procedural maintenance, including safety system updates.
Supports the QPPV in due diligence activities for acquisitions, mergers, or divestments and ensures traceability of QPPV input and decisions.
Prepares, provides input, and/or manages the process for internal and external presentations.
Responsible for facilitating and driving decision-making in support of QPPV Office objectives.
Defines, designs, and implements new processes and tools to ensure integration across the QPPV Office, GPS, and the broader organization.
Manages the QPPV SharePoint site.
Identifies and analyzes problems, creates tasks, and develops solutions to cross-functional and/or organizational issues.
Drives processes to support new approaches for sharing information among QPPV Office stakeholders.
Supports QPPV Office business continuity by documenting QPPV coverage arrangements (e.g., handover meetings) and escalation pathways.
Enables QPPV oversight of technology initiatives impacting PV, supporting proportionate, traceable documentation of technology risk within the QPPV oversight framework.
Effectively communicates information and aligns resources to continuously coordinate and collaborate across functions by providing information regarding the QPPV Office’s needs and services to key stakeholders and GPS leadership.
Provides administrative support to the QPPV Office, including preparation of workshops, meeting agendas and minutes, presentations, and summaries of QPPV activities and dashboards.
Influences resource prioritization decisions across the QPPV Office’s portfolio.