Patient Safety Sr. Medical Director, Global PV/ Patient Safety Medical Operations Excellence

Job Description

Role Summary

Supervise medical reviews for ICSRs during both clinical development and post-marketing, managing workflows and oversight to ensure evaluations are timely, accurate, and compliant. Serve as the main contact between operations and global patient safety medical teams. This position will contribute to setting standards, enhancing quality and inspection preparedness, executing vendor management, and working with both internal and external stakeholders to share medical expertise with operations teams and communicate operational regulatory requirements to the medical and PV Science groups.

Key Responsibilities

• Lead the operational strategy and standards for ICSR medical review across all case types.
• Conduct thorough clinical evaluations, handling complex cases and support prioritization of the medical review workflow.
• Connect ICSR reviews to benefit-risk assessment, informing signal detection and management activities.
• Ensure compliance with global regulations and internal procedures; lead QA/QC improvements and enhance inspection preparedness in collaboration with PV Compliance and ICSR Teams.
• Refine and monitor KPIs/SLAs for medical review timeliness, accuracy, and consistency; drive process enhancements and support automation efforts with both internal and vendor staff.
• Oversee vendor performance and harmonize medical review training and processes for internal/external teams.
• Collaborate cross-functionally within GPS to ensure medical insights inform safety reports and risk management plans.
• Maintain governance documentation and deliver metrics and analyses to leadership.

Qualifications

• MD or DO Required; board certification preferred.
• 10+ years in Pharmacovigilance, 5+ in global medical review management.
• Strong knowledge of PV regulations, inspection, and audit processes.
• Proficient with Argus Safety Database and vendor management/oversight.
• Experience integrating medical review of ICSRs into signal detection and management.

Skills

• Expert clinical judgment and narrative writing.
• Deep regulatory and compliance expertise.
• Proven operational leadership and change management.
• Systems/data skills, especially Argus and E2B(R3).
• Effective communicator and cross-functional collaborator.

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