Director, Patient Safety ICSR

Key Duties And Responsibilities

• Builds and leads an initiative-taking, efficient, and effective team.
• Collaborates with cross-functional teams to establish, implement, and oversee processes for drug-device combination product quality complaint triage and adverse event reporting.
• Contributes 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 pharmacovigilance (PV), 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).
• 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.
• Supports key GPS operational goals and objectives.

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.
• Able 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

Disclosure Statement

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation Remote-Eligible Flex Eligibility Status In this Remote-Eligible role, you can choose to be designated as: Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select Hybrid: work remotely up to two days per week; or select 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. 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