Associate Director, PV Safety Database Management
4 weeks ago
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.
-
new jersey, United States Daiichi Sankyo, Inc. Full timeJoin 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...
-
new jersey, United States Daiichi Sankyo, Inc. Full timeJoin 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...
-
Director, PV Strategic Partner Management NJ
4 weeks ago
new jersey, United States Daiichi Sankyo, Inc. Full timeJoin 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...
-
Senior PV Director
1 hour ago
New York, New York, United States Lifelancer Full timeSenior PV Director Job Summary:The Senior PV Director will lead the development and execution of global pharmacovigilance processes and deliverables, supporting ongoing clinical trials and vendor oversight.This position requires expertise in pharmacovigilance, with knowledge of FDA, EMA, and other regulatory adverse event reporting regulations and the...
-
new jersey, United States Daiichi Sankyo, Inc. Full timeJoin 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...
-
new jersey, United States Daiichi Sankyo, Inc. Full timeJoin 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...
-
new jersey, United States Daiichi Sankyo, Inc. Full timeJoin 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...
-
new jersey, United States Daiichi Sankyo, Inc. Full timeJoin 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...
-
Jersey City, United States Mitsubishi Tanabe Pharma America Full timePharmacovigilance (PV) Audit Manager (P/T Consultant)ContractEntrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach –...
-
Associate Director
2 days ago
New York, United States Lifelancer Full timeJob DescriptionJob DescriptionJob Title: Associate Director - PharmacovigilanceJob Location: New York, NY, USAJob Location Type: RemoteJob Contract Type: ContractJob Seniority Level: Mid-Senior levelDescriptionThe PV Associate Director is accountable for the development and execution of global pharmacovigilance processes and deliverables. This position will...
-
Director of Outsourced Partner Services
3 weeks ago
new jersey, United States Daiichi Sankyo, Inc. Full timep>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...
-
Manager of Safety Data Exchange and Compliance
4 weeks ago
New York, New York, United States Daiichi Sankyo, Inc. Full timeCareer OpportunitiesThe Manager of Safety Data Exchange and Compliance at Daiichi Sankyo, Inc. plays a critical role in ensuring the company's compliance with global PV regulations and guidelines. This includes developing and maintaining strategic partnerships with vendors, negotiating and revising contracts, and providing oversight of ICSR processing...
-
Clinical Director for Global Patient Safety
1 month ago
New York, New York, United States Lifelancer Full timeRole OverviewLifelancer is a talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, and IT. We are seeking a skilled Clinical Director to join our team.Job SummaryThe successful candidate will oversee the safety profile of assigned Lundbeck products according to FDA and global regulatory Pharmacovigilance...
-
Construction Safety Manager
7 days ago
New Albany, United States HazTek Safety Management Full timeJob DescriptionJob DescriptionThe Safety Manager supports specific project needs by ensuring best practices are implemented, safety compliance requirements are met, and enhance a culture of safety.Oversee all aspects of a commercial construction project ensuring OSHA complianceConduct daily safety meetingsComplete accident reports and conduct accident...
-
Global Pharmacovigilance Systems Manager
4 hours ago
New York, New York, United States Daiichi Sankyo, Inc. Full timeAbout UsDaiichi Sankyo Group is a leading pharmaceutical company dedicated to delivering innovative therapies that improve patient outcomes and address unmet medical needs. With over 125 years of scientific expertise, we have established a presence in over 20 countries and employ 18,000 people worldwide.Job Title: Global Pharmacovigilance Systems ManagerWe...
-
Database Manager
2 days ago
New Haven, United States The Community Foundation for Greater New Haven Full timeNOTE: APPLICANTS MUST FOLLOW THE APPLICATION INSTRUCTIONS LISTED IN THIS JOB DESCRIPTION TO BE CONSIDERED. The Community Foundation for Greater New Haven, the region's largest grant maker and permanent charitable endowment, is seeking a qualified candidate for the position of Database Manager. The Community Foundation's mission is to inspire, support,...
-
Database Director
2 weeks ago
New York, New York, United States City of New York Full timeJob OverviewThe City of New York is seeking a highly skilled Director of Database Administration to join its team. As a key member of the Department of Social Services (DSS), this role will be responsible for providing strategic operational, analytical, and systems support services.
-
Associate Director, Lab Operations
5 days ago
New York, United States NewYork BIO Full timeassociate director lab operations safety 0Associate Director, Lab Operations & SafetyDevelop and oversee general laboratory policies and proceduresOversee equipment sourcing and logistics, including coordination with finance teams for quoting and required specificationsDevelop and oversee organization and general upkeep strategies for the labOversee EH&S...
-
Director, Pharmacovigilance Scientist
3 days ago
New Providence, NJ, United States ADC Therapeutics Full timeNew Providence, NJJob TypeFull-timeDescriptionDirector, Pharmacovigilance ScientistNew Providence, NJ/HybridTransforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission.Why ADC TherapeuticsADC Therapeutics (NYSE): is a...
-
Solar PV Origination Expert
4 weeks ago
New York, New York, United States UGE International Full timeWe are seeking a highly motivated and experienced Director of Commercial & Industrial Development to join our team at UGE International. As a key member of our commercial and industrial solar development team, you will be responsible for leading our efforts to develop and execute a strategy to source and secure C&I solar and storage projects that meet our...
