Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 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. Job Summary:
This position is responsible for processing, evaluating, and submitting adverse event reports in accordance to DSI policy and regulatory authority requirements. This position includes the assignments of bulk reporting and triage function including SME's in the assigned role. This level interacts within CSPV for the majority of the time, which includes interactions with other DSPD sites and giving ICSR notifications to partners. This position is expected to handle ICSR issues in accordance with SOPs, SOIs, and experience and escalate more complex problems to Level III. Responsibilities:
Case Processing: Adverse event case processing for clinical and spontaneous cases, including case data collection and entry into the global safety database. Entry includes medical history, laboratory data, and concomitant and co-suspect drug products. Includes the review and evaluation of event(s) to determine seriousness criteria and listedness according to DSI product information. Requires knowledge and use of MedDRA and WHO-Drug dictionaries for coding of adverse events, medical history, lab data and co-suspect and concomitant medications. Ensures case details are complete, initiates follow up on reports as needed, and prepares adverse event reports, including Analysis of Similar Events (AOSE) as applicable. Performs review of cases entered by vendors. Supports ICSR CAPA generation.
Triage Designee: Includes the daily review and evaluation of potential adverse event(s) in Triage workflow to determine case seriousness, priority and reportability. Includes the assignment of cases to internal DSI team and CRO for Data Entry and/or review. Includes the management of queries received from CROs, partners, and DS affiliates.
Bulk Reporting Designee: Includes the daily review and evaluation of DSI bulk reporting and local labeling workflows. Includes submission of all DSI responsible regulatory reports, partner notifications and required local labeling for DSI affiliate reports.
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/Experience:
Bachelor’s Degree in nursing, pharmacy, or healthcare related field required
1 or More Years of PV experience and knowledge of FDA regulations 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.