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Pharmacovigilance Systems & Innovations Associate

  • Full Time, onsite
  • The Fountain Group
  • South San Francisco, United States of America
Salary undisclosed

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  • Pay: 35.00-42.00/hr.
  • Length of Assignment: 6 months to start with potential for extension or conversion.
  • Hybrid role: 2-3 days a week onsite.
  • The PV Systems Solutions & Innovations Associate provides operational support to the US Patient Safety Clinical and Vendor Oversight teams to ensure proper performance of baseline PV compliance based responsibilities.
  • This is done through implementation and regulation of global processes, local legislation, case investigation, and study management. Responsibilities are performed under the direction of the Senior Manager, PV Systems Solutions of Operations & Innovations.
  • Perform Individual Case Safety Reports (ICSR) Activities.
  • Performs Outbound Submission and Tracking (OST) for literature ICSRs and submits relevant documentation to health authority.
  • Ensure any non-compliance or late ICSR from programs are identified and ensure deviations are filed in accordance with global processes.
  • Assists and collaborates with Global ICSR team to inform on US Affiliate ICSR compliance performance and risks.
  • Performs daily workflow coordination and initial review of cases that are processed by our internal teams.
  • Oversees the enrollment process and proper onboarding of GVP vendor.
  • Vendor Oversight for Outsourced Pharmacovigilance (PV) Activities.
  • Pay: 35.00-42.00/hr.
  • Length of Assignment: 6 months to start with potential for extension or conversion.
  • Hybrid role: 2-3 days a week onsite.
  • The PV Systems Solutions & Innovations Associate provides operational support to the US Patient Safety Clinical and Vendor Oversight teams to ensure proper performance of baseline PV compliance based responsibilities.
  • This is done through implementation and regulation of global processes, local legislation, case investigation, and study management. Responsibilities are performed under the direction of the Senior Manager, PV Systems Solutions of Operations & Innovations.
  • Perform Individual Case Safety Reports (ICSR) Activities.
  • Performs Outbound Submission and Tracking (OST) for literature ICSRs and submits relevant documentation to health authority.
  • Ensure any non-compliance or late ICSR from programs are identified and ensure deviations are filed in accordance with global processes.
  • Assists and collaborates with Global ICSR team to inform on US Affiliate ICSR compliance performance and risks.
  • Performs daily workflow coordination and initial review of cases that are processed by our internal teams.
  • Oversees the enrollment process and proper onboarding of GVP vendor.
  • Vendor Oversight for Outsourced Pharmacovigilance (PV) Activities.