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PV Case Management and Quality Lead

PV Case Management and Quality Lead

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PV Case Management and Quality Lead

  • Location:

    United States of America

  • Sector:

    Pharmacovigilance - Pharma

  • Contact:

    Denise Carroll

  • Salary:


  • Job type:

    Permanent - full time

  • Contact email:

  • Job ref:


  • Published:

    14 days ago

  • Startdate:


MSI Pharma are working with a global pharmaceutical company to source an experienced PV professional to join their team and lead their case management division.

Main Responsibilities:

  • Responsible to monitor vendor case processing quality for all global CHC cases
  • To implement inline quality check process and effectiveness of the CAPAs for quality issues
  • Investigates and documents scores below quality thresholds.
  • Partners with the operations teams, global case processing centres, and Affiliates/CSH to develop strategies for quality improvements.
  • Documents, monitors, and trends reasons for late submissions and opening Quality Investigations for identified trends.
  • Develops, reviews, implements, and/or validates new metrics presentations, visualizations, and reports.
  • 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.
  • Participate in audits and inspections as Subject Matter Expert (SME) for PV submissions and Quality activities, performing User Acceptance Testing (UAT) of reports, and visualizations, as necessary.
  • Responsible for US case management activities and other PV ops related activities including but not limited to Inbound & outbound reconciliation, submission, late case analysis, inspection support for USFDA.
  • Case information received by the local PV and by global intake teams is registered, in the PV Database according to the case management SOP.
  • To automate the case intake for all sources IN US
  • Case relevant information processed in the system is distributed and reported according to the case management SOP to fulfil legal and partner agreement compliance requirements.
  • To ensure the local requirements which are configured in the safety database, for automated and manual distribution are accurate for their Health Authority and local partners.
  • Responsible for USFDA HA inspections and US country PV audits for case management related activities and other activities under PV ops scope
  • To drive business improvement for the tasks in collaboration with the involved staff and provide input to the updates of quality documents.
  • To generate user requirements for technology enhancements for inbound processing and lead the implementation from a business perspective.
  • Responsible to manage submissions to USFDA from safety database.
  • 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.
  • To identify outsourcing opportunities and lead the transfer of knowledge to the vendor.
  • To design a Hub case intake oversight approach in alignment with global expectations
  • To ensure follow up to ICSRs is performed according to WIN, and when applicable to supervise the team responsible for outbound calls during which sensitive cases are medically documented.
  • Analyses trends for reasons of late submissions to HA or LP and Works with key stakeholders to ensure robust corrective/preventative and effectiveness checks are implemented.