Director, Patient Safety ICSR

Vertex Inc.•Boston, MA

2d•$196,200 - $294,400•Remote

About The Position

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.

Requirements

Firsthand experience with all operational aspects of ICSR processing and reporting specifically those pertaining to drug-device combination legislation and implementation.
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.
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.

Nice To Haves

Line management experience preferred.

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.