Job Description

Johnson & Johnson is currently recruiting for a Manager, Pharmacovigilance Compliance and Quality (New Consumer Health Company). This position will be located in Fort Washington, Pennsylvania, or Skillman, New Jersey.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.

With $82.1 billion in 2020 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals.

It is anticipated that, following conclusion of the transaction, this position may be conveyed with New Consumer Health. In that case, details of any planned changes would be provided to the successful candidate by New Consumer Health at an appropriate time and would be subject to any necessary consultation processes.
: The Manager, Pharmacovigilance Compliance and Quality Oversight, is primarily responsible for the operational aspects of the Compliance Strategy and Analytics (CSA), Individual Case Safety Report (ICSR), core End of Line Quality (EOLQ) review process, investigating and documenting late ICSR, Aggregate Report and ESI/SSI submissions to Health Authorities, monitoring the timely exchange of ICSRs with Alliance Partners and, monitoring inbound ICSR performance from multiple sources. The Manager is responsible for seeing the generation, quality review, and distribution of compliance and quality metrics and trending activities. They will participate in audits and inspections as Subject Matter Expert (SME) for PV Compliance and Quality activities, performing User Acceptance Testing (UAT) of reports, and visualizations, as necessary. They must participate in and/or lead cross-functional compliance, quality, and process improvement initiatives while providing input into corrective/preventative actions and effectiveness measures for Corrective and Preventative Action plans (CAPA), as appropriate. The manager will also be responsible for resolving complex issues related to day-to-day activities independently, determining when to escalate issues to senior management, and oversight of vendor resources performing services on behalf of CSA.
Roles and Responsibilities:

• Operational Performance Analysis
  • Manages the PV Quality Review Process
  • Coordinates with Compliance Senior Management and QPPV to ensure consistent fulfillment of the global PV obligations
  • Partners with the operations teams, global case processing centers, and Local Operating Companies/Local Safety Officers to develop strategies for quality and compliance improvements
  • Partners with internal stakeholders to monitor vendor quality
  • Investigates and documents scores below quality thresholds
  • Manages responses to Health Authority Data Quality Reports
• Investigations of Late Health Authority and Alliance Partner Submissions
  • Investigates late ICSR, Aggregate Report, ESI/SSI submissions to Health Authorities (HA)
  • Documents, monitors, and trends reasons for late submissions and opening Quality Investigations for identified trends
  • Monitors Inbound and Outbound PVA compliance to Alliance Partners (AP) and documents reasons for lateness where threshold is met, or late exchange causes late Health Authority Submissions to Health Authorities
  • Analyzes trends for reasons of late submissions to HA or AP
  • Opens Quality Investigations when trend is identified
  • Works with key stakeholders to ensure robust corrective/preventative and effectiveness checks are implemented
  • Monitors ICSR inbound performance from multiple sources to drive high HA compliance and opening QI when trends are identified
• Generation and distribution of Pharmacovigilance Compliance and Quality Metrics
  • Generates, reviews, and distributes compliance and quality metrics for the oversight of the Quality Management System
  • Collaborates with key stakeholders to ensure metrics meet oversight needs
  • Develops, reviews, implements, and/or validates new metrics presentations, visualizations, and reports
    

Qualifications
Position Requirements:

• Minimum of bachelor's Degree in a relevant discipline (Business, Science, Medical, Operations, etc.) with 8 years of pharmaceutical industry experience or advanced academic degree with 5 years of pharmaceutical industry experience
• Minimum of 5 years of experience in PV and/or PV compliance monitoring
• Knowledge of GxP requirements
• Experience with safety processing, clinical study safety reporting, PV, and medical information
• Knowledge of global PV laws and regulations
• Experience in participation, management, or conduct of audits/inspections
• Proficiency in Microsoft Excel and SharePoint
• Problem-solving skills to interpret data & information, analyze, and make recommendations

Preferred Requirements:

• Ability to function in a global matrix environment
• Excellent communication and writing skills
• Ability to lead global work streams, drive teams to make decisions, achieve deliverables and, manage and resolve issues independently
• Understanding of and experience with multi-cultural working
• Ability to evaluate processes and procedures against outcomes to identify methods to improve efficiency, accuracy, and compliance
• Ability to utilize appropriate initiative and autonomy in achieving objectives
• Excellent track record with negotiation and collaboration
• Project Management experience with organizing actions and managing team activities
• Experience developing and conducting presentations for different levels of management with the ability to tailor presentations to the appropriate level of detail

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.

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-7050 Camp Hill Road
Other Locations
North America-United States-Pennsylvania-Horsham, Asia Pacific-Philippines-National Capital-Manila, Asia Pacific-India-Maharashtra-Greater Mumbai, United States-New Jersey-Skillman, United Kingdom-England-High Wycombe
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
2206064890W