Johnson & Johnson Careers

MANAGER GLOBAL AGGREGATE REPORTS

Fort Washington, Pennsylvania; Skillman, New Jersey
Drug & Product Safety Operations


Job Description

Requisition ID: 8473181130

Janssen Research & Development, LLC, a member of the J&J Family of Companies, is recruiting for a Manager Global Aggregate Reports to work in Fort Washington, PA or Skillman, NJ.

 

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine

 

The Manager Global Aggregate Reports supports the Associate Director in all activities associated with the aggregate analysis and regulatory activities. She/he will be responsible for core safety deliverables including scheduled and unscheduled aggregate reports, Risk Management plans (RMPs) and Company Core Data Sheets (CCDS) and will serve as the report owner for assigned reports. The manager is an aggregate reporting expert and will have in-depth product knowledge to support daily activities including planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, project management/coordination of strategic safety documents, and oversight of deliverables produced by other team members. The manager 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. She/he will partner with team members, stakeholders including Medical Safety Officers (MSOs), Qualified Person for Pharmacovigilance (QPPV) as appropriate, Global Case Management, Epidemiology, Regulatory Affairs, Clinical and Medical Affairs, Safety Data Analytics, Local Safety Officers (LSOs), and contracted vendor organizations.

 
 
  • Ensure timely, quality reports/safety analyses related to core deliverables as appropriate:
    • Collaborate with report physician, QPPV (where applicable) and other stakeholders on strategy development
    • Provide oversight of staff involved in aggregate reporting
    • Develop quality systems and procedures for the aggregate analysis and reporting of adverse effects related to Consumer products, to assure regulatory compliance with company standards and regulatory requirements
    • Initiate/Conduct/Oversee searches of internal and external databases
    • Perform management review of all vendor produced materials (e.g. draft reports and assessment responses); and/or lead aggregate safety analysis and case level review
    • Author, contribute, and coordinate the preparation of core safety deliverables
    • Prepares global aggregate reports for local authorities
    • Ensure compliance (quality, procedures, regulations, consistency) and commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met, where applicable
    • Partner with vendor to develop reports/deliverables
     
                                     
  • Training/Meetings/Audits/Inspections
 
    • Participate in cross-functional training of relevant stakeholders
    • Act as product or process Subject Matter Expert (SME) during audits/inspections
    • Daily management of vendor activities and responsibility for compliance with SOPs/WIs, global regulations/guidelines by either onsite or offshore resources
    • Develops and coordinates processes for offshore vendor
    • Performs training, onboarding, and oversight of offshore vendor
    • Trains, self, employee, and contractors on the pharmacovigilance responsibilities prior to work engagements; updates training of self and others as required in compliance with schedules and regulations
 
  • Department initiatives
    • Participate or lead· department and/or cross-functional initiatives
    • Contributes metrics and ensures reports’ accuracy and timelines are met
 
  • Recognize potential issues and or safety issues and escalate appropriately per Company policy
  • Ability to understand nature of adverse drug reactions and complex associations
  • Insight and examples of application of management skills required to lead global, outsourced operations
  • Advanced level working knowledge of safety databases to identify inefficiencies or the need for system enhancements High level of flexibility and ability to (re)prioritize work of oneself and others
  • Attention to detail and ability to analyze data in broader context
  • Ability to work across multiple functions and therapeutic areas
  • Review regulatory assessor comments/requests and address as appropriate
  • Manage vendor activities and resolves potential issues
 


Qualifications
Qualifications:
 
  • A mininm of 3 years of aggregate reporting related experience required
  • Bachelor degree in life-sciences or health-care field or advanced degree (e.g., MS, MPH, PharmD, or PhD), preferred with 2 years of experience in Pharmacovigilance or related industry.
  • Proven experience working in matrix environment and cross-functional teams
  • In-depth working knowledge of AE safety databases to identify system enhancements and efficiencies
  • Comprehensive clinical/medical writing experience
  • Strong English verbal and written communication skills
  • Scientific Skillset: Comprehensive Analytic and Conceptual Skills
  • Independence: Moderate independence or Independent; (Contributor/Co-lead/Lead)
  • SME with in-depth product knowledge of assigned products; knowledge and hand-on experience in aggregate reports writing and compliance management
  • Working knowledge of applicable global, regional, and local regulatory requirements (eg, ICH guidelines)
  • Up to 10% travel required
 

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

 


Primary Location
United States-Pennsylvania-Fort Washington-1100 Virginia Drive
Other Locations
United States-New Jersey-Skillman
Organization
J & J Consumer Inc. (6101)
Job Function
Drug & Product Safety Operations
Requisition ID
8473181130