Power point presentation Star approach Local Qualified Person


As the Local Qualified Person (QP) for Pharmacovigilance/Pharmacovigilance Officer you will act as local Qualified Person for customers requiring the services for their product.Responsibilities

  • ??Act as the local Qualified Person in accordance with requirements set out in IQVIA Lifecycle Safety
  • Regulatory Intelligence Database (RID). 
  • ??Availability on a 24/7 basis to receive calls from the local Competent Authority as required. Act as the contact point for pharmacovigilance inspections. Deal directly with the Competent Authority inspectors during statutory inspections.
  • ??Respond fully and promptly to requests from Competent Authorities to evaluate the benefits and risks of a medicinal product to include information regarding sales or prescriptions or post-authorization of safety studies of medicinal I products.
  • ??Verifies that his/her name and contact details have been notified to the Competent Authority upon contract commencement.
  • ??Remain up to date and aware of any changes in local regulatory requirements; verifies the necessary mechanisms and regulatory measures adopted for safety reasons and the risk management plans are carried out.
  • ??Establish and maintain a thorough understanding of each project’s budget and scope of work
    (SOW); set up and maintain project materials such as project files, forms, templates, databases and workflow.
  • ??Provide regular reports to project manager on project metrics, SOW changes, customer requests or concerns.
  • ??Communicate regular monthly updates to the EU

QPPV/designee & complete regulatory reports as required.

Presentation Title: STAR approach (Situation Task Action Result).

Present the skills that are required for the imaginary position.

Provide two situations where you successfully influenced and managed a team to produce positive results

Provide two situations where you had to communicate and drive an unpopular decision 

What is your greatest learning experience in people management/interactions

How would you react in the following situations:

Two of your direct reports have conflict One of your direct reports is underperformance 

One of your direct reports is underperformance and needs to terminate but is very emotional and start crying during delivering of your decision.

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