PV Manager, Case Management
Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: February 22, 2021
PV Manager, Case Management in Basking Ridge, NJ at DSI Job
DescriptionJoin 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
This position performs and functions as the subject matter expert
in ICSR processing and strategic partner/CRO case processing
oversight. This position has potential primary responsibility for
the daily workflow monitoring of incoming ICSRs, in-line QC of
ICSRs, SAE reconciliation, daily ICSR inquiries from CROs/vendors,
ICSR CAPA generation, and support in audits and inspections. CRO
Case Processing Oversight includes case mentorship; case quality
review, training material development. This level interacts with
the CSPV team and has interactions with other DS affiliate sites.
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, escalating problems to PV management as needed.
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
CRO/Vendor Case Processing Oversight:. Mentors and acts as a
subject matter expert in case processing procedures with Strategic
Partners and CROs engaged in case processing activities. Daily
oversight of inquiries, troubleshooting, and coordination of issue
resolution. Samples and reviews cases according to Quality Plans
including the review and evaluation of all case entries to ensure
accuracy. Guides the Strategic Partner in any case related
corrections required. Provides mentorship to the Strategic Partner
and determines mentorship planning and scheduling. Independently
manages all case related issues with the Strategic Partner and CROs
engaged in case processing activities. Escalation to Strategic
Partner Management as appropriate for partnership related issues
(i.e. SLA). Monitors strategic partner and CROs engaged in case
processing activities performance, identifies areas for improvement
and coordinates improvement initiatives.
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. Collaborates with CS Physicians on
protocol related and other training materials.
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.
Ensures consistency with global procedures and applicability to
CRO/vendor case processes to ensure success.
Qualifications: Successful candidates will be able to meet the
qualifications below with or without a reasonable
Bachelor's Degree in nursing, pharmacy, or healthcare related field
Master's Degree/ PharmD preferred
4 or More Years of PV experience and strong knowledge of FDA
regulations, clinical, and safety databases with direct experience
in case processing oversight and vendor relationship
Supervisory/management/project manager experience preferred
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.
Candidates with Disabilities Who Require Assistance Daiichi Sankyo,
Inc. provides reasonable accommodation in job application
procedures for qualified individuals with disabilities and disabled
veterans. If you have a disability that inhibits your ability to
apply for a position through our online application process or you
otherwise need accommodation in connection with the recruiting
process due to a disability, you may use the alternative methods
described below to contact us about your interest in Daiichi
Sankyo, Inc. and/or to request an accommodation. Daiichi Sankyo,
211 Mt. Airy Road Basking Ridge, NJ 07920-2311
Attn: Staffing Dept. By Phone: Phone: 908-992-6400 Equal
Opportunity Employment 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.
Keywords: Daiichi Sankyo, Newark , PV Manager, Case Management, Executive , Basking Ridge, New Jersey
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