Job Description
GENERAL POSITION SUMMARY
The Clinical Trial Safety Surveillance Sr. Manager works closely with the GPS physician and clinical medical directors to monitor the safety of ongoing clinical trials. The primary responsibility is reviewing and compiling all clinical trial safety data, including serious adverse events (SAEs) reported to global safety database, and adverse event (AE) and safety assessment results reported in the clinical database. The Clinical Trial Safety Surveillance Sr. Manager will raise any potential safety issues for Disease Area Safety Team (DAST) assessment.
GENERAL RESPONSIBILITIES AND REQUIRED SKILLS
Demonstrates strong ability to communicate effectively in a matrix environment
Exhibits ability to multi-task effectively
Demonstrates solid project management skills and strong attention to details
Ability to complete work in a resourceful, self‑sufficient manner while maintaining a strong mentality
Demonstrates solid written and oral communication skills and sound attention to detail
Ability to analyze, interpret, and summarize complex data with oversight
Exhibits firm comprehension of established procedures and shows initiative to solve routine issues
Demonstrate good knowledge of GCP, ICH, and global regulations
Possesses computer skills to support use of electronic systems and development of writing deliverables
KEY RESPONSIBILITIES
Work with GPS, Clinical Development, and Translational Medicine physicians to monitor the safety of ongoing clinical trials
Perform ongoing review of emerging safety data from clinical trials including, but not limited to, AEs/SAEs, laboratory, electrocardiogram, and vital sign results to identify any potential safety issues
In collaboration with physicians, prepare material for and present at the clinical trial safety review meeting
Ensure timely identification and communication of any potential safety issues emerging from ongoing clinical trials to the DAST Lead/Chair
Support DAST meeting as necessary
Participate in first-in-human safety data review and dose escalation meetings
Support safety-related documents/sections in the clinical program development (e.g., CSR narratives, drug authorization applications)
Support data review and presentation development for data monitoring committee meetings
Support other clinical development related activities as appropriate
Develop and maintain Informed Consent Product Safety Language for assigned products
Support other safety related activities
PREFERRED EDUCATION AND EXPERIENCE
Bachelor of Science or other advanced healthcare degree
At least 3 years Pharmaceutical industry experience
Pay Range $132,900 – $186,100 USD annually
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.
#LI-AR1 #LI-R
Pay Range: $132,080 – $198,120
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:
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 [email protected]
Vertex Pharmaceuticals
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