Manager, Safety Systems Data Mgmt & Analytics

Company: Daiichi Sankyo, Inc.
Location: Basking Ridge
Posted on: March 19, 2023

Job Description:

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. 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 manages delivery of configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Systems, and fulfillment of data request. The position acts as the Clinical Safety and Pharmacovigilance (CSPV) Local Liaison for configuration activities, including reviewing global validation evidences, and leading/overseeing PQ activities. This position assists PV Data Management & Analytics team in liaising with the Information Technology Informatics and Service Delivery team. This position is responsible for regular communication within local DSI CSPV teams and Global DS CSPV teams with updates to safety systems and providing status reports on various PV Systems activities. This position independently handles the most complex technical problems and assists in making decisions on database-related activities.

Responsibilities

• Application Management:
  • Act as Business Project Manager for all technology implementations in CSPV Department
  • Manage and oversee the day-to-day running of IPOS Systems to sustain CSPV ObjectivesAct as Business representativeon IPOS Systems installation, configuration and integration with different Argus Suite of products.
  • Liaise with the Application Managed Services (AMS) vendor in troubleshooting of IPOS Systems
  • Oversee Configuration of IPOS Systems modules with the AMS Vendor:Interchange module- E2B R2, E2B R3 ModuleArgus Console ConfigurationAG Service ConfigurationESM configuration oAxway ConfigurationConvergeHEALTH Safety System Configurations
  • Provide business requirements and recommendations around IPOS Systems configuration.
  • Working in coordination with Global AMS team on Oracle SRs.
  • Support Drug Safety Dictionary version management, such as MedDRA, WHO dictionaries, and upgrades as required byCSPV Operations.
  • Change Requests:
    • Collaborate Cross functionally to understand and analyze the scope of change.
    • Take part in impact analysis of changes to IPOS Systems identifying the risks, benefits and assist with assessing thecosts associated with the change.
    • Suggest alternate solutions and provide technical recommendations for Changes
    • Manage Implementation and documentation of Change Request supporting documents and evidences
    • Review of Change Request, supporting documents and evidences
    • KPI Management:
      • Measure the KPIs on periodic basis---Perform trend analysis, report on the KPIs and trends---Coordinate with Quality and Compliance group to take necessary action on the trends---Document KPI Reports
      • Other:---Create and maintain schedules for CSPV System Projects---Status reports on the projects---Maintain compliance with relevant policies and procedures---Support the investigation and resolution of complex, cross-functional issues using strong problem solving abilities
        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)
        • Bachelor's Degree in technical field preferred Experience Qualifications
          • 7 or More Years of experience in Drug Safety and Pharmacovigilance. preferred
          • 4 or More Years of experience specific to database validation processes, database business configuration, and data querying. 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.
            

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