Manager, Global Aggregate Reporting - Bernards, United States - Daiichi Sankyo, Inc.
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 16,000 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 will support Daiichi-Sankyo global aggregate reporting (AR) for investigational and post-marketed medicinal products within the Clinical Safety and Pharmacovigilance (CSPV) department. Since a global vendor has been engaged to manage aggregate reporting for the Daiichi Sankyo portfolio, this position is responsible for providing managerial leadership and oversight of AR activities and workflow (e.g. scheduling, kick-off meeting, generation of data, preparation, distribution, submission compliance tracking etc.) for the Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER), and Periodic Benefit-Risk Evaluation Report (PBRER), including but not limited to processes for periodic line listings. This position provides subject matter expertise and technical guidance on functional requirements and enhancements to meet emerging global regulatory requirements and implementation of global aggregate reporting solutions and training; monitors compliance metrics; and implements corrective and preventative actions to remediate non-conformance issues. This role is also responsible for managing the scheduling and workflow of aggregate reports through the established Company process that includes but not limited to ensure timely, consistent, and accurate development of aggregate reports in accordance with International Council for Harmonisation (ICH) & Food and Drug administration (FDA) and other applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs). Additionally, currently CSPV, like other functions at Daiichi-Sankyo, is undergoing globalization. Therefore, this candidate will be required to provide operational as well as strategic support to the aggregate report leadership in ongoing globalization of aggregate reporting at the 3 major business units in Japan, Europe and the US.
Responsibilities
- Aggregate report generation and managementOversight of all aggregate report activities (e,g. scheduling, chairing kickoff meeting, distribution etc), primarily the DSUR, PADER, PBRER, and including but not limited to processes for other periodic line listings.Manages aggregate report/periodic line listing process from preparation until approval and distribution of final report for regulatory submissions by collaborating with internal/external stakeholders.Controls and assures the quality of the scientific and material content of any documents, files, or other materials sent to regulatory agencies. Performs management review of all strategic partner produced materials, i.e., draft reports. Represents Aggregate Reports in cross-developmental and cross-company teams.Maintains oversight of vendor(s) sourced to prepare and complete aggregate reports. This includes management of training, contracts and relationship maintenance, and conducting trainings, mentoring onboarding of vendors as needed. Ensures vendor compliance with DS procedures and Key Performance Indicators. Assist aggregate report leadership in making adjustments and improvements as needed.Committed to continuous improvement around development of new aggregate report workflow/process, updates to aggregate report templates and aggregate report procedural documents (e.g. SOPs) as appropriate.
- Aggregate report ComplianceDaily project management of strategic partner activities and responsibility for compliance with SOPs and global regulations.Leads AR compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance for aggregate reports.Develops quality systems, tools, and procedures for the aggregate report activities to assure regulatory compliance and meet regulatory reporting timelines.Controls and assures the quality of the material content of any documents sent to regulatory authorities.Ability to accurately generate and provide aggregate report compliance metrics to senior management.
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 preferably in healthcare or life sciences required
- Master's Degree preferred
Experience Qualifications
- 7 or More Years of pharmaceutical industry experience required
- 4 or More Years experience in Pharmacovigilance required
- 1 or More Years experience in authoring and developing aggregate safety reports (e.g. DSUR, PADER) preferred
- Possess knowledge and expertise of ICH guidelines and global regulations (e.g. GCP/GPvP). required
- Project management experience 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.