At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Job Summary

• Will work with the Director, Clinical Study Startup to establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations. 
• Oversees the creation of SAE Flow Plans and may perform final review. 
• Provide input on electronic data capture (EDC) Safety report outputs, reviews clinical study and post-marketing protocols and the Clinical Study Oversight Plan, day-to-day management of DS Safety Notification Letter (SNL) System and oversee TMF activities. 
• Interact with global study teams and represent PV operations in global interactions with CS Physicians and other study team members. 
• Oversee and may engage within CSPV and with CROs to execute study start up processes. 
• This level will handle problems requiring escalation from others and make decisions where appropriate and escalate any complex problems to the Director, Clinical Study Startup.
• This position requires strong organization and interpersonal skills and is able to work effectively with people at different levels of an organization and different cultures.

Job Description

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 act as PV Operations SPOC for study teams to ensure consistency and compliance across clinical study safety reporting and activities.

Global Management Strategy and Goals and Procedure Development:

• Assist Leadership to ensure compliance with protocol and internal/external standards.
• Identifies and drives strategy for process improvement initiatives.
• Reviews and provides input to SOPs, SOIs, and process guides.

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 oversees the maintenance of the study specific SAE Flow Plan and collaborates with on behalf of CSPV Operations any other study related documentation such as the DMP, SOWs, PVAs, Clinical Study Oversight Plans, day-to-day management of DS Safety Notification Letter (SNL) System and presentations and documents.

Electronic Data Capture (EDC):

• 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.

Qualifications

Education Qualifications

• Bachelor of Science degree required 
• Master's degree, RN or PharmD preferred

Experience Qualifications

• 4+ years of drug safety experience with technical experience in Electronic Data Capture and Safety Reporting required.
• 10+ years 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.

Salary Range:

USD$150,800.00 - USD$226,200.00