GLOBAL PATIENT SAFETY JOB DESCRIPTION
TITLE/ROLE: Global Patient Safety Individual Case Safety Report (ICSR) Specialist
GENERAL POSITION SUMMARY
The Global Patient Safety Individual Case Safety Report (ICSR) Specialist is responsible for performing Individual Case Safety Report (ICSR) processing activities, including narrative writing, event coding, and pursuit of follow-up information. The Global Patient Safety ICSR Specialist applies technical proficiency and attention to detail in ICSR processing as well as the ability to interpret and execute projects, with minimal guidance. This individual ensures that all work performed is in accordance with relevant regulatory guidelines.
GENERAL RESPONSIBILITIES AND REQUIRED SKILLS
• Sound ability to communicate effectively in a matrix environment
• Ability to multi-task
• Solid written and oral communication skills
• Sound attention to detail
• Strong sense of responsibility and an ability to work autonomously, as well as act as a strong team player
• Displays ability to understand established procedures and communicate those procedures to others
• Ability to prioritize workload
• Proficiency in Office environment computer applications
• Proficiency in safety database navigation including understanding of various medical coding applications
KEY RESPONSIBILITIES
• Reviews and interprets all new and follow-up ICSR source documentation to determine the appropriate information to enter into the Global Safety Database
• Responsible for the management of all assigned ICSRs from receipt to ICSR closure, including follow-up requests
• Ensures that all international regulations are followed regarding PV procedures.
• Participates as a cross functional team member of Study Execution Teams
• Interfaces with study sites to ensure complete, accurate and timely reporting of safety information
• Participates in Serious Adverse Event (SAE) Reconciliation activities
• Performs periodic Global Safety Database searches to support inquiries from stakeholders as required
• May assists in the creation of ad hoc safety reports for submission to relevant stakeholders
• May assist more senior department members with signal detection activities, as needed
• May conduct presentations of safety issues, initiatives and projects
• Reviews and may be responsible for authoring Standard Operating Procedures (SOPs) and Working
Instructions, with minimal supervision
• Performs other duties as assigned
PREFERRED EDUCATION AND EXPERIENCE
• B.S. in a scientific or allied health field (or equivalent degree) and 3 – 5 years of relevant work experience, or
• PharmD, M.S.N (or equivalent degree) and 2 – 4 years of relevant work experience, or relevant comparable backgroundGLOBAL PATIENT SAFETY JOB DESCRIPTION
TITLE/ROLE: Global Patient Safety Individual Case Safety Report (ICSR) Specialist
GENERAL POSITION SUMMARY
The Global Patient Safety Individual Case Safety Report (ICSR) Specialist is responsible for performing Individual Case Safety Report (ICSR) processing activities, including narrative writing, event coding, and pursuit of follow-up information. The Global Patient Safety ICSR Specialist applies technical proficiency and attention to detail in ICSR processing as well as the ability to interpret and execute projects, with minimal guidance. This individual ensures that all work performed is in accordance with relevant regulatory guidelines.
GENERAL RESPONSIBILITIES AND REQUIRED SKILLS
• Sound ability to communicate effectively in a matrix environment
• Ability to multi-task
• Solid written and oral communication skills
• Sound attention to detail
• Strong sense of responsibility and an ability to work autonomously, as well as act as a strong team player
• Displays ability to understand established procedures and communicate those procedures to others
• Ability to prioritize workload
• Proficiency in Office environment computer applications
• Proficiency in safety database navigation including understanding of various medical coding applications
KEY RESPONSIBILITIES
• Reviews and interprets all new and follow-up ICSR source documentation to determine the appropriate information to enter into the Global Safety Database
• Responsible for the management of all assigned ICSRs from receipt to ICSR closure, including follow-up requests
• Ensures that all international regulations are followed regarding PV procedures.
• Participates as a cross functional team member of Study Execution Teams
• Interfaces with study sites to ensure complete, accurate and timely reporting of safety information
• Participates in Serious Adverse Event (SAE) Reconciliation activities
• Performs periodic Global Safety Database searches to support inquiries from stakeholders as required
• May assists in the creation of ad hoc safety reports for submission to relevant stakeholders
• May assist more senior department members with signal detection activities, as needed
• May conduct presentations of safety issues, initiatives and projects
• Reviews and may be responsible for authoring Standard Operating Procedures (SOPs) and Working
Instructions, with minimal supervision
• Performs other duties as assigned
PREFERRED EDUCATION AND EXPERIENCE
• B.S. in a scientific or allied health field (or equivalent degree) and 3 – 5 years of relevant work experience, or
• PharmD, M.S.N (or equivalent degree) and 2 – 4 years of relevant work experience, or relevant comparable background
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
Location/Region: Boston,MA