Associate Director, Clinical Study Startup, Clinical Safety and Pharmacovigilance

Position: Clinical Study Startup Specialist

Company Overview:

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. The Group's 2025 Vision is to become a "Global Pharma Innovator with Competitive Advantage in Oncology," primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Description:

• Work with the Director, Clinical Study Startup to establish strategy for global Clinical Study Start-Up activities for PV Safety Operations.
• Oversee the creation of SAE Flow Plans and perform final reviews.
• Provide input on electronic data capture (EDC) Safety report outputs.
• Review clinical study and post-marketing protocols and the Clinical Study Oversight Plan.
• Manage 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.

Responsibilities:

• Represent PV Operations at multidisciplinary study meetings providing guidance on safety operations, oversight of initiatives, and troubleshooting issues.
• Act as a liaison for CS Physician and Data Management for study-related safety reporting.
• Assist Leadership to ensure compliance with protocol and internal/external standards.
• Identify and drive strategy for process improvement initiatives.
• Review and provide input to SOPs, SOIs, and process guides.
• Review clinical study protocols to ensure consistency in safety requirements across studies.
• Develop and oversee maintenance of the study-specific SAE Flow Plan.
• Collaborate on study-related documentation including DMP, SOWs, PVAs, Clinical Study Oversight Plans, and management of DS Safety Notification Letter (SNL) System.
• Establish EDC strategy at the project and/or study level with Data Management.
• Identify and manage risks at the project and/or study level related to data capture and reporting.
• Establish EDC standards for reporting to ensure quality and compliance in safety reporting.

Requirements:

• Bachelor's degree in Science required; Master's degree, PharmD, or RN degree preferred.
• 4 or more years of drug safety experience with technical experience in Electronic Data Capture and Safety Reporting required.
• 10 or more years of total pharmaceutical industry experience in areas such as Drug Safety, Epidemiology, and Clinical Development preferred.

Commitment to Diversity:

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.