Job Description

General Summary:

The Director, Global Patient Safety Individual Case Safety Report (ICSR) oversees global ICSR processing and external PV partners and vendors. This position manages the technical aspects of end-to-end safety case intake, processing, quality control, and regulatory submissions within a therapeutic area (as assigned) covering the applicable drug, biologic, medical device, and combination products, ensuring operations are consistent, compliant, and inspection-ready worldwide.

The Director, Global Patient Safety Individual Case Safety Report (ICSR) plays a key role in global ICSR processing excellence and external business management. This position serves as a subject matter expert in pharmacovigilance (PV) and contributes to developing and implementing standards and best practices in Global Patient Safety (GPS), particularly for legislation governing drug-device combination products. The role also represents GPS in cross-functional initiatives and requires strong technical PV expertise, communication, project management, and vendor management skills. Additionally, this position supports key GPS operational goals and objectives .

Key Duties and Responsibilities:

• Builds and leads an initiative-taking, efficient, and effective team.
• Cross-functional collaboration to establish, implement, and oversee the processes pertaining to drug-device combination product quality complaint triage and adverse event reporting.
• Contribute to the implementation of Global Safety Database configurations for drug-device combination products as required.
• Contributes to the ongoing development of innovative ICSR best practices.
• Leads and mentors' staff in all aspects of PV (pre- and post-market), including stakeholder engagement, project maintenance, and delivery of high-quality cases on time.
• Provides guidance to staff on technical aspects of clinical trials and post-market case processing.
• Contributes to the development of standardized practices, procedures, metrics, and Key Performance Indicators (KPIs)
• Provides management and oversight of business partners and vendors, including PV agreements, safety reporting plans, and vendor contracts, as applicable.
• Represents GPS in cross-functional initiatives and meetings.
• Promotes a culture of high performance and accountability.
• Inputs technical expertise to production of compliance and operational reports
• Maintains currency with evolving international guidance and regulations for PV, especially regarding ICSR processes and reporting requirements.
• Collaborates with GPS Quality, Standards & Training in the identification and remediation of regulatory/compliance risks and quality improvements.
• Assist with direct case processing activities, as needed.

Knowledge and Skills:

• Firsthand experience with all operational aspects of ICSR processing and reporting specifically those pertaining to drug-device combination legislation and implementation.
• Line management experience preferred.
• Excellent project management skills with the ability to align internal and external resources.
• Possess a keen sense of responsibility, ability to work autonomously, and be a strong collaborator.
• Ability to manage and react constructively in a high-energy and demanding environment.
• Excellent interpersonal and communication skills including verbal/written and presentation skills.
• Ability to evaluate and analyze procedural gaps.

Education and Experience:

• B.S. (or equivalent) in life sciences or allied health professional degree with 10+ years of direct pre- and post-marketing PV experience required.
• 5+ years of direct external partner and vendor/outsourcing management experience required.

Pay Range:
$196,200 - $294,400

Flex Designation:
Remote-Eligible

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.

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