Patient Safety ARRM Manager

Job Description

General Summary:

The Patient Safety Aggregate Reports and Risk Management (ARRM) Manager will be responsible for the preparation of aggregate safety reports, including PSURs, PADERs, and DSURs, for assigned Vertex products, marketed or in development. The Patient Safety ARRM Manager will collaborate closely with Global Patient Safety Physicians on product safety teams and supporting risk management activities, including signal detection and tracking, Regulatory Authority requests, and maintenance of risk management plans (RMPs).

Key Duties and Responsibilities:

• Contributes to ARRM activities for Vertex products, marketed or in any phase of development
• Prepares aggregate safety reports, including establishment of timelines, content and project management, safety database report requests, review of data/information, and compilation of information
• Supports Disease-area Safety Team (DST) through meeting preparation and conduct, signal detection/tracking, Development RMP and RMP maintenance, and other DST risk management activities
• Plans and reviews literature search results, in collaboration with the applicable GPS Safety Physician, for identification of potential safety issues/signals and inclusion in applicable aggregate safety reports
• Collaborates with Regulatory Affairs and other functions to coordinate submission of aggregate safety reports
• Collaborates with Quality, Standards & Training to ensure aggregate safety report procedures, training, and activities are sufficiently defined and maintained.
• Participates in departmental development activities including SOP and Work Instruction development, Audits and Inspections.
• Performs other duties as assigned

Knowledge and Skills:

• Demonstrates strong ability to communicate effectively to exchange complex information with others
• Exhibits ability to multi-task effectively
• Demonstrates solid written and oral communication skills, and sound attention to detail
• Ability to analyze, interpret, and summarize moderately complex data with general oversight
• Exhibits firm comprehension of established procedures
• Applies good understanding of industry practices for drug development and pharmacovigilance
• Demonstrates basic knowledge of related disciplines, and an understanding of general concepts and experiential detail within those areas
• Possesses computer skills to support use of electronic systems and development of writing deliverables

Education and Experience:

• PharmD, PhD, MPH, advanced healthcare degree, or equivalent professional experience
• Typically requires 3 years of experience in pharmacovigilance or relevant experience with, data analysis and medical/scientific writing

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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.

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