Manager, Clinical Study Start Up, Pharmacovigilance - Daiichi Sankyo Inc.
Basking Ridge, NJ
About the Job
Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study Oversight Plan,day-to-day management of DS Safety Notification Letter (SNL) System and manages uploads to TMF activities. This position will interact with global study teams and represent PV operations in global interactions with CS Physicians and other study team members. This position will also engage within CSPV and with CROs to execute study start up processes.
Responsibilities
+ Global PV Operations Representation on Clinical Study Teams: Represents PV Operations at multidisciplinary study meetings providing guidance on safety operations, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act as PV Operations SPOC for study teams to ensure consistency and compliance across clinical study safety reporting and activities.
+ Global Clinical Study Start-Up Documentation: Reviews all clinical study protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains the study specific SAE Flow Plan and collaborates with on behalf of CSPV Operations any other study related documentation such as the DMP and day-to-day management of DS Safety Notification Letter (SNL) System.
+ Electronic Data Capture (EDC) Responsibility: In conjunction with Data Management, establish the EDC strategy at the project and/or study level. Proactively identifies and manages risks at the project and/or study level as it relates to data capture and reporting. Establishes EDC standards for reporting to ensure quality and compliance in safety reporting.
+ Procedure Development: Supports the process redesign activities to ensure compliance and consistency across clinical study start-up activities. Reviews and provides input to SOPs, SOIs, and process guides.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
+ Bachelor's Degree Science required
Experience Qualifications
+ 4 or more years drug safety experience with technical experience in Electronic Data Capture and Safety Reporting
+ Must have knowledge and expertise in Pharmacovigilance (PV)
+ 7 or more years MS, RN, or PharmD preferred, or total pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferred
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study Oversight Plan,day-to-day management of DS Safety Notification Letter (SNL) System and manages uploads to TMF activities. This position will interact with global study teams and represent PV operations in global interactions with CS Physicians and other study team members. This position will also engage within CSPV and with CROs to execute study start up processes.
Responsibilities
+ Global PV Operations Representation on Clinical Study Teams: Represents PV Operations at multidisciplinary study meetings providing guidance on safety operations, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act as PV Operations SPOC for study teams to ensure consistency and compliance across clinical study safety reporting and activities.
+ Global Clinical Study Start-Up Documentation: Reviews all clinical study protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains the study specific SAE Flow Plan and collaborates with on behalf of CSPV Operations any other study related documentation such as the DMP and day-to-day management of DS Safety Notification Letter (SNL) System.
+ Electronic Data Capture (EDC) Responsibility: In conjunction with Data Management, establish the EDC strategy at the project and/or study level. Proactively identifies and manages risks at the project and/or study level as it relates to data capture and reporting. Establishes EDC standards for reporting to ensure quality and compliance in safety reporting.
+ Procedure Development: Supports the process redesign activities to ensure compliance and consistency across clinical study start-up activities. Reviews and provides input to SOPs, SOIs, and process guides.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
+ Bachelor's Degree Science required
Experience Qualifications
+ 4 or more years drug safety experience with technical experience in Electronic Data Capture and Safety Reporting
+ Must have knowledge and expertise in Pharmacovigilance (PV)
+ 7 or more years MS, RN, or PharmD preferred, or total pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferred
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.
Source : Daiichi Sankyo Inc.
