Data Coordinator, 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 is responsible for carrying out case receipt and data entry of post-marketing and clinical SAEs, and for tracking and reconciling SAE exchange. This position understands safety database and workflow and basic regulatory requirements, and may assist in generating standard database queries. This position may assist in the monthly maintenance and reconciliation of departmental submissions trackers (such as regulatory submissions). This position also carries out some administrative tasks (e.g., creating files, pulling folders from file room). 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 handles straightforward problems with supervision and decisions are limited to data entry processes and often require manager approval.Responsibilities

• Case Receipt/Book-In: Primarily responsible for case receipt/book-in processes. This includes monitoring of e-mail boxes for new cases, performing duplicate checks, booking cases into the safety database and attaching electronic source documents, as well as creating/retrieving case file folders.
• Data Entry: Primarily responsible for data entry of post marketing and clinical SAEs under strict regulatory and internal timelines. This requires a basic knowledge of regulatory reporting requirements, as well as the ability to interpret source documents to accurately enter the information into the safety database.
• Reconciliation: Performs monthly maintenance and reconciliation of trackers for safety data exchanged with license partners and CROs.
• Querying/Reporting: Performs standard database searches/output in support of clinical-safety database reconciliation, as well for routine recurring monthly requests safety data.
• Submissions Trackers: May assist with monthly maintenance and reconciliation of departmental submissions trackers, such as expedited regulatory submissions and Safety Notification Letters.

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)

• High School Diploma required

Experience Qualifications

• 1 or More Years of experience in pharmaceutical safety required

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.