Vertex
Senior Manager, Clinical Trial Safety Surveillance (Remote)
Vertex, Boston, Massachusetts, us, 02298
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
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 select2.
Hybrid : work remotely up to two days per week;
or select3.
On-Site : work five days per week on-site with ad hoc flexibility.
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.
#J-18808-Ljbffr
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
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 select2.
Hybrid : work remotely up to two days per week;
or select3.
On-Site : work five days per week on-site with ad hoc flexibility.
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.
#J-18808-Ljbffr