Associate, Case Processing CSPV

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 is responsible for administrative tasks (e.g., mailbox management). This level interacts with internal and interdepartmental teams the majority of the time with occasional communication with external vendors and the global CSPV team. This position assists in the monthly maintenance and reconciliation. This position is expected to handle ICSR issues in accordance with SOPs, SOIs, and experience and escalate more complex problems to management.

Responsibilities:

• Case Receipt/Book-In/ Case Processing: This includes monitoring of e- mail boxes for new cases, performing duplicate checks, entering PQC information/follow up outreach attempts and attaching electronic source documents, as well as creating/retrieving case file folders.

• Reconciliation: Performs monthly maintenance and reconciliation of trackers for safety data exchanged with license partners and CROs. Participates in clinical SAE reconciliation

• Querying/Reporting: Performs standard database searches/output in support of clinical-safety database reconciliation, as well for routine recurring monthly requests safety data.

• Case Processing Policies and Procedures: Participates in development of process guides which are used to ensure consistency and compliance in case processing and adherence to regulatory guidelines.

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 in nursing, pharmacy, or healthcare related field preferred

Experience Qualifications:

• 1 or more years of relevant healthcare experience required

• 1 or more years PV experience required

• Knowledge of FDA regulations. preferred

Competencies:

• Delivers high quality work, assesses individual and vendor/CRO work with minimal supervision

• Executes strategic plans within multiple projects and can prioritize in accordance with strategy.

• Competent in identifying and understanding issues independently and can contribute to remediation plans

• Competent knowledge of pharmacology, clinical research and medical terminology, global data entry conventions and systems and procedures for application in daily work.

• Communicates effectively with team/project members using clear and effective verbal and written communication skills

• Effectively manages own workload to meet multiple deadlines in a timely manner.

• Understands functional role and others’ functional roles within the clinical trial process

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.