Manager, PV Database Management & Analytics

Join a Legacy of Innovation – 125 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 18,000 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.

This position manages delivery of configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Systems and fulfillment of data requests. The position acts as the Clinical Safety and Pharmacovigilance (CSPV) Local Liaison for configuration activities, including reviewing global validation evidence and leading/overseeing PQ activities.

This position assists the PV Data Management & Analytics team in liaising with the Information Technology Informatics and Service Delivery team. It is responsible for regular communication within local DSI CSPV teams and Global DS CSPV teams, providing updates on safety systems and status reports on various PV Systems activities. The role independently handles the most complex technical problems and supports decision-making on database-related activities.

Application Management

• Act as Business Project Manager for all technology implementations in the CSPV Department.

• Manage and oversee the day-to-day running of IPOS Systems to sustain CSPV objectives.

• Act as Business Representative on IPOS Systems installation, configuration, and integration with different Argus Suite of products.

• Liaise with the Application Managed Services (AMS) vendor for troubleshooting IPOS Systems.

• Oversee configuration of IPOS Systems modules with the AMS vendor:

  • Interchange Module – E2B R2, E2B R3

  • Argus Console Configuration

  • AG Service Configuration

  • ESM Configuration

  • Axway Configuration

  • ConvergeHEALTH Safety System Configurations

• Provide business requirements and recommendations around IPOS Systems configuration.

• Work in coordination with the Global AMS team on Oracle SRs.

• Support Drug Safety Dictionary version management, including MedDRA, WHO dictionaries, and required upgrades for CSPV Operations.

Change Requests

• Collaborate cross-functionally to understand and analyze the scope of change.

• Conduct impact analysis of changes to IPOS Systems, identifying risks, benefits, and associated costs.

• Suggest alternate solutions and provide technical recommendations.

• Manage implementation and documentation of Change Request supporting documents and evidence.

• Review Change Requests, supporting documents, and validation evidence.

KPI Management

• Measure KPIs on a periodic basis.

• Perform trend analysis, report on KPIs, and monitor trends.

• Coordinate with the Quality and Compliance group to take necessary action based on trends.

• Document KPI reports.

Other Responsibilities

• Create and maintain schedules for CSPV System Projects.

• Provide status reports on projects.

• Ensure compliance with relevant policies and procedures.

• Support the investigation and resolution of complex, cross-functional issues using strong problem-solving abilities.

Education Qualifications (from an accredited college or university)

• Bachelor's Degree in a relevant technical discipline required.

Experience Qualifications

• 7+ years of experience in Drug Safety and Pharmacovigilance required

• 4+ years of experience in database validation processes, database business configuration, and data querying 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.