BioSpace, Inc.
Associate Director, Data Management & Analytics
BioSpace, Inc., Basking Ridge, New Jersey, us, 07920
Job Details
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 thedelivery of systems, configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests.
Responsibilities
Change Requests for PV SystemsCollaborate 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 evidenceReview of Change Request, impact analysis, supporting documents and evidenceSupport with implementing and ensuring global DBMA quality standards for Change requestsIT Vendor Oversight and Management
Managing CSPV IT Budget for Local DSI CSPV SystemsMonitoring disruptions in customer service and internal operations, while ensuring the highest level of qualityCollaborate 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 interactionServe as the leadership-level point of contact between the vendor organization and internal customers consuming vendor services and solutionsManage vendor relationships as the key point of contact between specified vendors and the businessEvaluating, communicating, and mitigating potential risks.Implementation of new CSPV Systems
Responsible for ensuring the design of the CSPV solution that satisfies the business process visionLead platforms and systems design and optimization to deliver best-in-class solutionsChange 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 modelDrive key project deliverables, including requirements definition, process design, solution design, test planning and execution, data readiness, cutover planning and execution, and post-go-live supportAdvocate 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 CSPVCollaborate cross-functionally with other business leads and SMEs to achieve the best system, business process solution, and customer experienceQuerying 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 ProvidersTraining and development of Service Provider resourcesFacilitates and participates in vendor and PV oversight activities such as vendor meetingsDetermines 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 issuesOther
Review and update of DMA ProceduresMaintain compliance with relevant policies and proceduresSupport the investigation and resolution of complex, cross-functional issues using strong problem-solving abilitiesQualifications:
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 preferredProficient 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 implementationHas a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a study protocolProficient in FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs. Understanding of global regulations preferredGood knowledge of Good Documentation PracticesEffectively manages shifting priorities; skillfully aligns resources as applicable to priorities that require immediate actionUnderstanding of ICH guidelines on PharmacovigilanceUnderstanding of MedDRA structureUnderstanding and application of guidelines detailed in FDA 21 CFR Part 11, including system validation requirementsAdvanced understanding of database structure (Argus Safety Database required, PV Reports, Signal Detection and Analytics Reporting module preferred)High level of proficiency with MS Office applicationsSolid written, verbal communication, and interpersonal skillsTime management and ability to prioritize workloadQuality orientation: attention to detail, accuracyAbility 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.
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 thedelivery of systems, configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests.
Responsibilities
Change Requests for PV SystemsCollaborate 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 evidenceReview of Change Request, impact analysis, supporting documents and evidenceSupport with implementing and ensuring global DBMA quality standards for Change requestsIT Vendor Oversight and Management
Managing CSPV IT Budget for Local DSI CSPV SystemsMonitoring disruptions in customer service and internal operations, while ensuring the highest level of qualityCollaborate 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 interactionServe as the leadership-level point of contact between the vendor organization and internal customers consuming vendor services and solutionsManage vendor relationships as the key point of contact between specified vendors and the businessEvaluating, communicating, and mitigating potential risks.Implementation of new CSPV Systems
Responsible for ensuring the design of the CSPV solution that satisfies the business process visionLead platforms and systems design and optimization to deliver best-in-class solutionsChange 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 modelDrive key project deliverables, including requirements definition, process design, solution design, test planning and execution, data readiness, cutover planning and execution, and post-go-live supportAdvocate 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 CSPVCollaborate cross-functionally with other business leads and SMEs to achieve the best system, business process solution, and customer experienceQuerying 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 ProvidersTraining and development of Service Provider resourcesFacilitates and participates in vendor and PV oversight activities such as vendor meetingsDetermines 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 issuesOther
Review and update of DMA ProceduresMaintain compliance with relevant policies and proceduresSupport the investigation and resolution of complex, cross-functional issues using strong problem-solving abilitiesQualifications:
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 preferredProficient 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 implementationHas a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a study protocolProficient in FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs. Understanding of global regulations preferredGood knowledge of Good Documentation PracticesEffectively manages shifting priorities; skillfully aligns resources as applicable to priorities that require immediate actionUnderstanding of ICH guidelines on PharmacovigilanceUnderstanding of MedDRA structureUnderstanding and application of guidelines detailed in FDA 21 CFR Part 11, including system validation requirementsAdvanced understanding of database structure (Argus Safety Database required, PV Reports, Signal Detection and Analytics Reporting module preferred)High level of proficiency with MS Office applicationsSolid written, verbal communication, and interpersonal skillsTime management and ability to prioritize workloadQuality orientation: attention to detail, accuracyAbility 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.