Patient Safety ICSR Manager
4 weeks ago
Patient Safety ICSR Manager page is loaded
Patient Safety ICSR Manager
Apply
locations
Boston, MA
time type
Full time
posted on
Posted 30+ Days Ago
job requisition id
REQ-21425
Job Description
The Patient Safety Individual Case Safety Report (ICSR) Manager is responsible for performing Individual Case Safety Report (ICSR) processing activities, including narrative writing, event coding, and pursuit of follow-up information. The Patient Safety ICSR Manager works with a high degree of independence and is proficient at troubleshooting problems to create and execute improved internal procedures, and to ensure compliance with applicable regulatory requirements. This role ensures that all work performed is in accordance with relevant regulatory guidelines. Provides guidance to others for ICSR processing.
Key Duties and Responsibilities:
Reviews and interprets all new and follow-up safety information to determine the appropriate information to enter into the Global Safety Database
Manages the process of all assigned ICSRs from receipt to ICSR closure, including follow-up requests
Performs triage activities for incoming ICSRs
Ensures that all international regulations are followed regarding pharmacovigilance (PV) procedures
Interfaces with study sites to confirm complete, accurate, and timely reporting of safety information
Performs periodic Global Safety Database searches to support inquiries from stakeholders as required
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
Assists in the training and development of other staff members in key processes and procedures
May conduct presentations of safety issues, initiatives and projects
Provides input on effectiveness of the safety management system and when applicable, provide suggestions for improvement of ICSR processing efficiency
Reviews and may be responsible for authoring, Standard Operating Procedures (SOPs) and Working Instructions, with minimal supervision
Helps to identify key departmental needs and provides constructive input on solutions
Participates as a cross-functional team member of Study Execution Teams
Participates in Serious Adverse Event (SAE) reconciliation activities
Assists in developing and maintaining PV agreements and manage relationships with Vendors/Business Partners
Identify, select, and manage relationships with Clinical Research Organizations for project management and related ICSR processing activities
Provide input on protocol development, as well as the development of Case Report Forms and Consent Forms
Mentors other Specialists and GPS staff
performs other duties as assigned
Knowledge and Skills:
Ability to work within a matrixed environment
Highly-skilled at multi-tasking with a keen attention to detail
Strong written and verbal communication skills to exchange sensitive/difficult information
Advanced understanding of established procedures and can communicate those procedures to others
Proficiency in Microsoft Office applications
Proficiency in safety database navigation including understanding of various medical coding applications
Comprehensive understanding of general PV concepts and practices
Education and Experience:
Bachelor's degree in a related field
4+ years of experience or the equivalent combination of education and experience
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.
Similar Jobs (2)
Executive Medical Director, Global Patient Safety
locations
Boston, MA
time type
Full time
posted on
Posted 30+ Days Ago
Senior Medical Director, Patient Safety
locations
Boston, MA
time type
Full time
posted on
Posted 30+ Days Ago
#J-18808-Ljbffr
-
Boston, United States Xenon Pharmaceuticals Inc. Full timeWho We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and...
-
Boston, United States Xenon Pharmaceuticals Inc. Full timeWho We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and...
-
Boston, United States Xenon Full timeWho We Are:Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and...
-
Boston, United States Xenon Full timeWho We Are:Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and...
-
Boston, MA, United States Xenon Pharmaceuticals Inc. Full timeDirector/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist) Boston, MA, USA Req #236 Friday, March 8, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of...
-
Manager, Safety Operations
4 weeks ago
Boston, Massachusetts, United States Cerevel Therapeutics Full timeCompany OverviewCerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central...
-
Medical Director, GDS
2 months ago
Boston, United States Alexion Pharmaceuticals, Inc. Full timeThis is what you will do: The Medical Director, Global Patient Safety (GPS) is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion's products by patients and healthcare providers. The Medical Director will be...
-
Medical Director, GDS
3 weeks ago
Boston, United States Alexion Pharmaceuticals, Inc. Full timeThis is what you will do: The Medical Director, Global Patient Safety (GPS) is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion's products by patients and healthcare providers. The Medical Director will be...
-
Medical Director, GDS
1 month ago
Boston, United States AstraZeneca Full timeThis is what you will do: The Medical Director, Global Patient Safety (GPS)is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion’s products by patients and healthcare providers. The Medical Director will be...
-
Construction Safety Manager
2 months ago
Boston, United States Environmental and Safety Solutions, Inc. Remote Work Freelance Full time $38 - $48ESS-051Location: Billerica, MA area - PER DIEM AVAILABLE!PAY RANGE: $35-48/hr. based off experience! OT AVAILABLE!Environmental and Safety Solutions Inc. is in search of a Construction Safety Manager with experience in the pharmaceutical industry. The ideal candidate will be comfortable in front of business owners, project management, and craft while in the...
-
Medical Director, GDS
2 months ago
Boston, MA, United States AstraZeneca GmbH Full timeThis is what you will do: The Medical Director, Global Patient Safety (GPS)is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion’s products by patients and healthcare providers. The Medical Director will be...
-
Patient Safety
2 weeks ago
Boston, United States Brigham & Women's Faulkner Hospital(BWFH) Full time**Patient Safety & Risk Specialist** - (3286476) The Patient Safety and Risk Specialist will support the Sr. Manager of Patient Safety and Risk at BWH/BWFH to oversee and manage hospital-wide patient safety and risk initiatives and daily work at BWH and BWFH. The Patient Safety and Risk Specialist will be responsible for keeping the institution current with...
-
Quality and Patient Safety Specialist
3 weeks ago
Boston, United States Boston Medical Center (BMC) Full timeQuality and Patient Safety Specialist ($130K)Boston Medical CenterRequirement:Masters or Bachelors DegreeExperience within Quality and Patient Safety Departments3-5 years’ experience combined with healthcare administration; minimum 1 year experience in clinical quality/patient safety.CPPS or CPHQ preferredPOSITION SUMMARY:The Quality & Patient Safety...
-
Quality and Patient Safety Specialist
2 months ago
Boston, United States Boston Medical Center (BMC) Full timeQuality and Patient Safety Specialist ($130K)Boston Medical CenterRequirement:Masters or Bachelors DegreeExperience within Quality and Patient Safety Departments3-5 years’ experience combined with healthcare administration; minimum 1 year experience in clinical quality/patient safety.CPPS or CPHQ preferredPOSITION SUMMARY:The Quality & Patient Safety...
-
Quality and Patient Safety Specialist
3 weeks ago
Boston, United States Boston Medical Center (BMC) Full timeQuality and Patient Safety Specialist ($130K)Boston Medical CenterRequirement:Masters or Bachelors DegreeExperience within Quality and Patient Safety Departments3-5 years’ experience combined with healthcare administration; minimum 1 year experience in clinical quality/patient safety.CPPS or CPHQ preferredPOSITION SUMMARY:The Quality & Patient Safety...
-
Quality and Patient Safety Specialist
2 months ago
Boston, United States Boston Medical Center (BMC) Full timeQuality and Patient Safety Specialist ($130K)Boston Medical CenterRequirement:Masters or Bachelors DegreeExperience within Quality and Patient Safety Departments3-5 years’ experience combined with healthcare administration; minimum 1 year experience in clinical quality/patient safety.CPPS or CPHQ preferredPOSITION SUMMARY:The Quality & Patient Safety...
-
Quality & Patient Safety Specialist
3 weeks ago
Boston, Massachusetts, United States Capstone Search Group Full timeAbout the RoleServing the Boston area for over 150 years, this medical center offers an opportunity to join their Quality & Patient Safety team. The Quality & Patient Safety Specialist plays a key role in supporting the development, implementation, management, and sustainment of an organization-wide system of quality and safety.Duties &...
-
Quality & Patient Safety Specialist
2 months ago
Boston, Massachusetts, United States Capstone Search Group Full timeAbout the RoleServing the Boston area for over 150 years, this medical center offers an opportunity to join their Quality & Patient Safety team. The Quality & Patient Safety Specialist plays a key role in supporting the development, implementation, management, and sustainment of an organization-wide system of quality and safety.Duties &...
-
Patient Safety
2 weeks ago
Boston, United States Mass General Brigham Full timePatient Safety & Risk Specialist-(3286476) Description The Patient Safety and Risk Specialist will support the Sr. Manager of Patient Safety and Risk at BWH/BWFH to oversee and manage hospital-wide patient safety and risk initiatives and daily work at BWH and BWFH. The Patient Safety and Risk Specialist will be responsible for keeping the institution...
-
Quality & Patient Safety Specialist (RN)
2 months ago
Boston, United States Boston Medical Center Full timePOSITION SUMMARY: The Quality & Patient Safety Specialist plays a role in supporting the development, implementation, management and sustainment of an organization-wide system of quality and safety. Working with the Quality & Patient Safety team and organizational cross-functional teams, the Quality & Patient Safety specialist will support activities to...
