Associate Director, Clinical Study Startup, Clinical Safety and Pharmacovigilance
: Job Details :

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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 works with the Director, Clinical Study Startup to establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations. This position oversees the creation of SAE Flow Plans and may perform final review. This position provides 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. 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 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.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 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) 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.

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 degree required
• Master's Degree preferred or
• PharmD preferred or
• RN degree preferred

Experience Qualifications

• 4 or More Years drug safety experience with technical experience in Electronic Data Capture and Safety Reporting. required
• 10 or More 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.