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Daiichi Sankyo, Inc.

Senior Scientist Pharmacovigilance

Post Date:Dec 27, 2017Type:Full-Time
Start Date:12/27/2017Salary:
Location:US-NJ-Bernards Job Reference:9050BR

Job Description:
Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo, Inc. is the U.S. subsidiary of Daiichi Sankyo, Co., Ltd. The Company currently markets therapies in hypertension, dyslipidemia, diabetes, acute coronary syndrome, thrombotic disorders, stroke risk reduction, opioid-induced constipation, IV iron therapy and metastatic melanoma.

Job Summary

This position performs and functions as the subject matter expert in ICSR processing. This position has primary responsibility for the daily triage of incoming ICSRs, bulk reporting assignment, and daily ICSR inquiries from CROs/vendors. This position may also include serving as PV Representative on study teams, compiling SAE section of IND report and compiling and reviewing assigned NDA PADERs. This level interacts with the CSPV team and has interactions with other DSPD sites. This level also interacts and participates on interdepartmental teams and reviews and troubleshoots vendor case processing. This position is responsible for handling complex ICSR issues, vendor case processing inquiries according to experience, escalating problems to Level III as needed.


1. Case Processing: Serves as the subject matter expert for this area, conducts complex case processing, review, and submission of ICRs; and 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. Review of cases processed by vendors.
2. Vendor Case Processing Oversight: In addition to review of vendor prepared cases assigned, is daily point of contact for ICSR case processing inquiries from vendors on coding and data entry conventions. May collaborate with PV sub teams to develop and present vendor training (and retraining as indicated) according to business need and experience.
3. PV Representative on Study Teams: Representative on Phase 2—3 study teams which includes attendance and participation in multidisciplinary study team meetings, providing updates to team and CSPV group as needed and escalating PV issues identified by the study team as required. May participate in study startup activities including case review and feedback. This assignment would include query oversight and SAE reconciliation as applicable.
4. Case Processing Training: Participates in developing and delivering case processing training to case processing staff , new hires and vendors as needed.
5. Aggregate Reports: Compiles SAE section of IND report and compiles and reviews assigned NDA PADERs.
6. Case Processing Policies and Procedures: Participates in development and update of case processing process guides.


Education and Experience
  • Bachelor’s in nursing, pharmacy, or healthcare related field, minimum of four (4) years of PV experience and knowledge of FDA regulations, clinical, and safety databases

1. Consistently monitors individual and vendor/CRO work to ensure timely completion of high quality deliverables.
2. Suggests innovative solutions to improve efficiency at the functional level.
3. Investigates complex issues thoroughly and formulates multiple potential solutions.
4. Possesses a proficient knowledge of pharmacology, clinical research and medical terminology, global data entry conventions and systems for application in daily work and within study teams.
5. Communicates effectively within team, cross functionally and consistently demonstrates clear verbal and written communication skills with internal and external stakeholders.
6. Effectively manages shifting priorities.
7. Demonstrates a comprehensive understanding of the functional roles within the clinical trial process.

Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.

Contact Information
Daiichi Sankyo, Inc.

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