Director, Patient Safety ICSR

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:

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 youre 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 Vertexs 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 persons 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