Mgr Aggregate Report in Bernards, NJ at DSI

Date Posted: 11/15/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Bernards, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/15/2018
  • Job ID:
    9386BR

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 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 hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary
This position supports the Strategic Partner Manager in all activities associated with aggregate safety reporting for investigational and post-marketed medicinal products. This position is responsible for oversight of aggregate report activities, primarily the Development Safety Update Report (DSUR) and Periodic Adverse Drug Experience Report (PADER) preparation and distribution process, and including but not limited to processes for other periodic line listings. This position serves as aggregate reporting expert in the review, analysis and regulatory reporting of aggregate adverse event reports. Additionally, this position provides technical as well as managerial leadership to a global staff of internal personnel and offshore strategic partner. 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 ICH & FDA guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs).

Responsibilities

Aggregate Reports Management:
  • Oversight of aggregate report activities, primarily the Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER), Investigational New Drug (IND) Annual Report preparation and distribution process, and including but not limited to processes for other periodic line listings.
  • Develop quality systems and procedures for the aggregate reporting activities to assure regulatory compliance with company standards and regulatory requirements.
  • Manages and publishes aggregate reports schedule in collaboration with other internal DS departments (Regulatory Affairs, Clinical Operations etc).
  • Chairs the Aggregate Reports Kick off meetings and coordination meetings
  • Manages aggregate report/periodic line listing process from preparation until approval and distribution of final report for regulatory submissions by collaborating with internal and external stakeholders
  • On boards new associates of Strategic Partner involved in authoring the aggregate reports to Daiichi Sankyo environment.
  • Performs training/mentoring, onboarding, and oversight of strategic partner.
  • Daily project management of strategic partner activities and responsibility for compliance with SOPs and global regulations.
  • Develops and coordinates processes for strategic partner for Aggregate Reports.
  • Provide oversight of internal personnel and strategic partner involved in aggregate reporting for investigational and post-marketed medicinal products.
  • 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.
  • Ensures the reports are generated in accordance with ICH & FDA guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs).
  • Ensures reporting timelines are met and reported internally.
  • Provide Aggregate Reports’ compliance metrics to management
  • Schedule and lead 'lessons learned' meeting following Aggregate Reports’ submission, as necessary
  • Contribute to development of new Aggregate Reports workflow or process as appropriate
  • Contribute to establishment or updates to conventions and templates
  • Contribute to continuous improvement

Qualifications

Education and Experience
  • Bachelor’s degree at minimum required preferably in healthcare or life sciences with minimum of seven (7) years of pharmaceutical industry experience.
  • Minimum of five (5) years experience in Pharmacovigilance.
  • Must possess at least one to two years of experience in authoring and developing aggregate safety reports (e.g. DSUR, PADER).
  • Must possess knowledge and expertise of ICH guidelines and global regulations (e.g. GCP/GPvP). Project management experience is preferred.
Competencies
  • Consistently monitors and assesses individual, team and/or vendor/strategic partner work to provide high quality deliverables that meet/exceed expectations; provides guidance to others within the function.
  • Suggests innovative solutions to improve efficiency/effectiveness at the functional level; solicits input and evaluates suggestions from others within the function.
  • Investigates complex issues thoroughly and formulates multiple potential solutions.
  • Maintains high level of expertise in ICH guidelines and global regulatory requirements (e.g. GCP/GPvP), and policies and procedures within the organization as well as Pharmacovigilance processes.
  • Possesses proficient knowledge such as pharmacology, clinical research, medical terminology, validated systems, and in Good Documentation Practices.
  • Communicates effectively within the team, cross-functionally, regionally and globally as applicable; demonstrates clear written communication skills with internal and external team/stakeholders.
  • Effectively manages shifting priorities; collaborates and communicates across functions to achieve critical priorities.
  • Possesses a comprehensive understanding of the functional roles within the clinical trial process.
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.