Associate Director of Medical Safety Performance - High Wycombe, United Kingdom - Kenvue

Kenvue
Kenvue
Verified Company
High Wycombe, United Kingdom

4 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

Associate Director of Medical Safety Performance and Compliance W


Description

Johnson & Johnson New Planned Consumer Health Company, based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S Baby, BAND-AID, NEUTROGENA, TYLENOL, MOTRIN, and LISTERINE. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.


The Associate Director of Medical Safety Performance and Compliance is responsible for supervising the effective monitoring and identification of improvements for the compliance of individual adverse event and aggregate adverse event report submissions to Health Authorities (HA) worldwide, and for the quality and accuracy of information contained within these reports.

This includes work performed by internal functions, alliance partners and vendors.


The Associate Director supports the Director of Medical Safety Performance and Compliance in identifying and addressing opportunities for improvement of cross-functional compliance, quality, and processes within the product vigilance (PV) system.


Responsibilities:

Develop and evolve processes to ensure effective oversight of PV system performance and compliance, including:

  • Compliance monitoring of global HA reporting of individual case safety reports (ICSRs), aggregate reports and emerging safety information (ESI)
  • Design and implementation of appropriate metrics and thresholds to measure report quality, submission timeliness and compliance performance
  • Development and storage of compliance deviation data
  • Ensuring monitoring of local operating companies in reporting AEs to central operations
  • Oversight of safety report exchange with PV agreement partners
  • Provision of independent compliance oversight for PV vendors and alliance partners who conduct activities in areas of PV submissions and/or other relevant PV related functions.
  • Ensuring monitoring and assessment of ICSRs quality and certain aggregate reports
  • Leading Compliance and Performance oversight fora when required, as delegated by the Director of Medical Safety Performance and Compliance
  • Manage the teams responsible for the execution of the performance and compliance processes.

Instigation of PV Compliance and Performance improvements;

  • Lead or support investigations into emerging quality or compliance trends.
  • Identify areas for improvement to ensure meaningful metrics to support operational oversight and in partnership with the QPPV, of the PV system.

Decision Making and problem solving;

  • Provide guidance and support to colleagues, including vendors and local safety units, in addressing issues related to performance, compliance and Medical Safety processes.
  • Guide Medical Safety and related functions in critical assessment of existing processes to identify areas for improvement and identification of interdependencies between functional processes.
  • Provide recommendations for systemic changes based on trend analysis.

Reporting Line;
Direct reporting relationship to the Director of Medical Safety Performance and Compliance.


Working relationships;

  • Global Head of Medical Safety Compliance, Policy and Oversight
  • QPPV frequent interaction in oversight of pharmacovigilance system quality and compliance
  • NCHC Quality collaborate with leadership and other members of the Quality function.

Qualifications

Education and Experience requirement;

  • A minimum of a university/bachelor's degree is required. An advanced businessrelated degree (MPH, M.B.A., J.D.) or an advanced health sciences degree (Ph.
D.) is preferred.

  • 5+ years of demonstrated experience in pharmacovigilance, experience in quality and compliance monitoring preferred.
  • Knowledge of global PV laws and regulations.
  • Experience with PV case processing and reporting preferred.
  • People leadership experience.
  • Ability to lead global work streams, drive teams to make decisions, achieve deliverables and manage and resolve issues independently.
  • Understanding of and experience with multicultural working preferred.
  • Excellent track record with negotiation and collaboration.
  • Process excellence, lean six sigma experience preferred.

Primary Location Europe/Middle East/Africa-United Kingdom-England-High Wycombe


Organization Johnson & Johnson Consumer Services EAME Ltd.


Job Function Drug & Product Safety Operations
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