Johnson & Johnson Careers

PROGRAM COORDINATOR

Fort Washington, Pennsylvania
Drug & Product Safety Operations


Job Description

Requisition ID: 6828190611

The Johnson & Johnson Group of Consumer Companies (JJGCC), is recruiting for a Program Coordinator located in Skillman, NJ, OR Washington, PA OR North America. 

 

The Program Coordinator, Central Pharmacovigilance HUB, coordinates the safety data management process for Market Research, Patient Support Program, and Real-World Evidence activities performed globally which includes verifying key safety supporting documentation is in place.

 
The Program Coordinator will:
 
  • Coordinate operational and training activities globally to ensure safety data is collected and analyzed by appropriate medical safety group
  • Collaborate and coordinate activities with key functional partners within J&J Pharmaceutical Sector such as Global International Pharmacovigilance (IPV), Global Commercial Strategy Organization (GCSO), Call Center and Local Safety Officers
  • Initate and follow-through of Investigations and CAPAs
  • Work with key functional partners to manage Investigations and CAPAs
  • Review and approve market research, patient support programs, and real-world evidence studies program safety data management plans as per SOPs/WIs
  • Liaise with Local Safety officers to ensure safety data is adequately collected
  • Ensure safety data reconciliation process is completed on time as per SOP
  • Collect quality and compliance metrics related to safety data management process
  • Liaise with external vendor as required for the coordination of the safety data management plan, reconciliation activities, contract verification or other related activity as outlined in Company policies and procedures
  • Interact with training vendor/function as required to ensure that safety data management training is complete for individuals involved in market research, patient support program and real-world evidence activities
  • Collaborate with IPV, GCSO, and Market Research organizations to streamline systems and
  • Processes
  • Establish relationships with IPV, GCSO, Call Center and Local Safety Officers, etc. to drive
  • operational excellence
  • Author standard operating procedures, work instructions and training materials for Market
  • Research, Patient Support Program, and Real-World Evidence AE/PQC activities
  • Performing root cause analysis techniques to support Investigations including but not limited
  • to: Brainstorming, data analysis and collection tools, 5 Whys, Fishbone (Cause and Effect),
  • FMEA, and DMAIC
  • Experience with tools and techniques supporting qualitative risk analysis including but not
  • limited to: Probability and impact assessment (likelihood of recurrence and potential effect),
  • probability and impact matrix (risk ratings, rating rules), and risk
  • Coordinate process improvements to drive efficiencies
  • Liaise with Market Research, IPV, GCSO and Local Safety Organizations
  • Balance interests of stakeholders to achieve performance and quality
  • Assist in the implementation of strategies supporting sustainable (financially rational, risk balanced, efficient, and high quality) delivery
  • Deals with issues using deductive reasoning, critical analysis skills and systematic approaches
  • Thinks in a clear, decisive manner, remains calm under adverse conditions, and reaches independent, reasoned decisions and solutions when required
  • Strong influence and negotiation skills
  • Role must have demonstrated critical thinking, leadership skills, and ability to interact with Regulatory Authorities
 


Qualifications

Qualifications

  • BS Degree in health-related field or other related scientific degree/qualification required
  • Minimum of 2 years of pharma or clinical experience preferred
  • Excellent communication skills, both written and verbal
  • Must be able to travel up to 10%
 
 
 
 


Primary Location
United States-Pennsylvania-Fort Washington-
Other Locations
North America
Organization
J & J Consumer Inc. (6101)
Job Function
Drug & Product Safety Operations
Requisition ID
6828190611