Senior Director, Patient Safety ICSR

Vertex Inc. • Boston, MA

1d • Remote

About The Position

The Senior Director, Head of Global Case Processing, is the strategic and operational leader responsible for the end-to-end management of Individual Case Safety Reports (ICSRs) across the global pharmacovigilance system. The Senior Director ensures consistent, compliant, and inspection-ready case processing operations for both marketed and investigational products, across all therapeutic areas and modalities.

Requirements

• Advanced degree in life sciences (PharmD, RN, MD, PhD, or equivalent) preferred; bachelor’s degree required
• 12+ years of experience in Pharmacovigilance, including significant leadership responsibility for global case processing operations
• Deep expertise in global safety database management (preferably Argus), ICH E2B(R3), MedDRA, and regulatory requirements for ICSRs
• Proven experience leading outsourced case processing activities and managing global vendor partnerships
• Strong knowledge of global regulations, standards and best practices regarding ICSR processing and reporting, safety surveillance and pharmaceutical industry compliance activities in pre-marketing and post-marketing
• Excellent communication, organizational, and decision-making skills
• Ability to work effectively in a fast-paced, matrixed, highly regulated environment with competing priorities and demonstrate strategic thinking balanced with deep operational expertise
• Maintains high ethical standards, including commitment to Vertex's values and behaviors

Responsibilities

• Provide vision and leadership for the global case processing function, setting long-term strategy, organizational priorities, and performance expectations
• Own and evolve the global case processing operating model, ensuring scalability for a broad and growing product portfolio, including ATMPs, gene-editing modalities, and combination products
• Oversee development of and/or contribute to standard processes and procedures for the handling of ICSRs to ensure compliance with global and local regulatory requirements
• Collaborate with internal stakeholders on the identification and implementation of continuous improvement as well as inspection readiness activities
• Ensure accurate, consistent data entry into the Argus (or equivalent) safety database, including maintenance of global conventions, workflows, and business rules
• Lead the quality strategy for all ICSRs, including QC processes, reconciliation, audit trail expectations, and metrics
• Ensure timely regulatory submissions of cases in accordance with global and local regulatory requirements and collaborate on investigation
• Drive innovation through automation, workflow simplification, and digital transformation to increase quality, efficiency, and scalability
• Lead, mentor, and develop a high-performing global Case Processing team, including internal staff and vendor teams
• Foster a culture of quality, ownership, accountability, continuous improvement, and operational excellence
• Ensure appropriate resource planning, workload distribution, and role clarity across regions and product portfolios
• Represent Case Processing in Steering Committees, management team meetings, and cross-functional teams as necessary
• Ensure operational excellence, consistency, and agility in a rapidly evolving PV landscape

Benefits

• This role is eligible for an annual bonus and annual equity awards.
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
• At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
• From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Director