Manager, PV Case Management in Basking Ridge, New Jersey at DSI

Date Posted: 11/5/2019

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 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 hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

This position performs and functions as the subject matter expert in ICSR processing, workflow monitoring, and ICSR Quality Control. This position has potential primary responsibility for the daily workflow monitoring of incoming ICSRs, in-line QC of ICSRs, and daily ICSR inquiries from CROs/vendors. Assists Vendor Coordinator with CRO Case Processing Oversight previously done by Vendor Management including case mentorship; training material development in conjunction with CS Physicians. This level interacts with the CSPV team and has interactions with other DS affiliate sites. Responsible for line listing quality review of ICSRs for internal and CRO processed cases. This level also interacts and participates on interdepartmental teams and reviews and troubleshoots CRO/vendor case processing. This position is responsible for handling complex spontaneous and clinical ICSR issues, internal and external case processing inquiries according to experience, escalating problems to PV management as needed. Supervisory/management/project manager experience preferred. This position also performs SAE reconciliation, and contributes to ICSR CAPA generation.

Responsibilities:
  • Case Processing: Serves as the subject matter expert for this area, conducts complex case processing, review, and submission of ICSRs. Performs Triage and review of Local Labeling and Bulk Reporting Argus functions. 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, and submissions to partners, investigators, and as required ensuring compliance with regulatory reporting.
  • CRO/Vendor Case Processing Oversight: Assists with CRO Case Processing Oversight including review of cases processed by vendors, participation in operation meetings with CROs/Vendors, case mentorship; training material development in conjunction with CSPV sub teams according to business need and experience.
  • Workflow Monitoring Designee: Monitors incoming cases received from CROs, cases in active workflow including pending follow-up, and facilitates timely completion of case processing activities.
  • Case Processing Training: Participates in developing and delivering case processing training to case processing staff, mentoring new hires and vendors as needed.
  • ICSR Quality Control Designee: Performs in-line quality control of cases within the Argus workflow, documents QC findings, provides feedback of QC findings, compiles monthly QC metrics, offers insights for continuous case processing improvement.
  • Case Processing Policies and Procedures: Participates in development and update of case processing process guides, SOP/SOIs.
Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Bachelor’s in nursing, pharmacy, or healthcare related field
  • Minimum of four (4) years of senior level PV experience and strong knowledge of FDA regulations, clinical, and safety databases
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.