Senior Director, Patient Safety ICSR

Job Description

GENERAL POSITION SUMMARY

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.

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS

This role oversees all operational processes related to safety data intake, processing, and reporting, as well as case workflow governance, and timely submission to regulatory authorities. The role also provides leadership for vendor-managed case processing operations, establishes robust global standards and conventions within the Argus safety database, and partners closely with cross-functional teams to ensure seamless safety data flow as required.

KEY 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

PREFERRED EDUCATION AND EXPERIENCE

• 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

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Remote

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com