Associate Director, PV Safety Database Management & Analytics at Daiichi Sankyo, Inc.

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 125 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. 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 disorders.   

Summary

This position manages the relationship and oversight of technology Service Providers and vendors. This position is also responsible for the delivery of systems, configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests.

Responsibilities

Change Requests for PV Systems

• 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 assisting with assessing the costs associated with the change.
• Suggest alternate solutions and provide technical recommendations for Changes and process improvements.
• Provide oversight, Manage Implementation and documentation of PV Safety systems Change Request supporting documents and evidence
• Review of Change Request, impact analysis, supporting documents and evidence
• Support with implementing and ensuring global DBMA quality standards for Change requests

IT Vendor Oversight and Management

• Managing CSPV IT Budget for Local DSI CSPV Systems
• Monitoring disruptions in customer service and internal operations, while ensuring the highest level of quality
• Collaborate with internal stakeholders — including IT and business resources, contracts, and procurement — to develop criteria and best practices for vendor selection.
• Establish and/or approve internal and external policies, standards, and processes for vendor interaction
• Serve as the leadership-level point of contact between the vendor organization and internal customers consuming vendor services and solutions
• Manage vendor relationships as the key point of contact between specified vendors and the business
• Evaluating, communicating, and mitigating potential risks.

Implementation of new CSPV Systems

• Responsible for ensuring the design of the CSPV solution that satisfies the business process vision
• Lead platforms and systems design and optimization to deliver best-in-class solutions

Change Requests for PV Systems

• Work cross-functionally and be the voice of CSPV on key system and business process decisions, informed by a deep understanding of the current operating model
• Drive key project deliverables, including requirements definition, process design, solution design, test planning and execution, data readiness, cutover planning and execution, and post-go-live support
• Advocate change management within CSPV department by assessing org impact, proactively communicating updates and changes, facilitating delivery of training, and ensuring training materials enable continuous education, and driving process and system adoption within CSPV
• Collaborate cross-functionally with other business leads and SMEs to achieve the best system, business process solution, and customer experience

Querying and Reports

• Develop complex ad hoc safety database searches and report output.
• For all data requests, perform self-QC of data to ensure quality of results.

Service Provider Oversight & Management

• Oversight of Data Request processing by Service Providers
• Training and development of Service Provider resources
• Facilitates and participates in vendor and PV oversight activities such as vendor meetings
• Determines priorities and resource load balancing to manage workload backlogs, action items, and business as usual.
• Leads or assists in the tracking and investigation of quality and compliance issues

Other

• Review and update of DMA Procedures
• 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 Technology field required

Experience Qualifications

- 7+ years of experience specific to managing PV System Implementation and validation processes, database business configuration, and data querying.

Core Competencies

Strongly preferred:

• Experience with administration of Argus Safety 8.4.x, 8.0.x and 7.0.x Patches.
• Experience with SQL programming/querying, custom report design/development from Argus Safety backend database.
• Strong knowledge of Oracle Argus Safety System ,PV Case Intake, PV Reports, Signal Detection and Analytics Reporting module is preferred
• Proficient ability to identify issues independently and thoroughly understands the causes of those issues; understands the impact within the team; provides suggestions for resolution and management of solution implementation
• Has a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical Trials
• Ability to extract configurable data fields from a study protocol
• Proficient in FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs. Understanding of global regulations preferred
• Good knowledge of Good Documentation Practices
• Effectively manages shifting priorities; skillfully aligns resources as applicable to priorities that require immediate action
• Understanding of ICH guidelines on Pharmacovigilance
• Understanding of MedDRA structure
• Understanding and application of guidelines detailed in FDA 21 CFR Part 11, including system validation requirements
• Advanced understanding of database structure (Argus Safety Database required, PV Reports, Signal Detection and Analytics Reporting module preferred)
• High level of proficiency with MS Office applications
• Solid written, verbal communication, and interpersonal skills
• Time management and ability to prioritize workload
• Quality orientation: attention to detail, accuracy
• Ability to exhibit project management skills

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.