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MANAGER GLOBAL AGGREGATE REPORTING RM

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Job Description


Johnson & Johnson is recruiting for a Manager, Global Aggregate Reporting & Risk Management, located in Fort Washington, PA/Skillman, NJ.


The Manager, Global Aggregate Reporting & Risk Management will support 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.


The Manager, Global Aggregate Reporting & Risk Management will:

  • 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
  • Participate or lead department and/or cross-functional initiatives
  • Contributes metrics and ensures reports’ accuracy and timelines are met


Qualifications
Qualifications
  • Bachelor degree in health-care field or advanced degree (e.g., MS, MPH, PharmD, or PhD) required
  • A minimum of three years of experience in Pharmacovigilance or relevant industry required
  • A minimum of three years of experience in Pharmacovigilance, Clinical or Regulatory medical writing required
  • Scientific Skillset: Comprehensive Analytic and Conceptual Skills
  • 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
Johnson & Johnson Consumer Inc. (6101)
Job Function
Pharmacovigilance
Requisition ID
9455191108