Head of Drug Safety & Pharmacovigilance

RBW Consulting Solutions Ltd Ver Empresa

Não especificado
Licenciatura

This expanding Pharma Company is looking to enhance the skills in this critical area and are seeking a medic or PhD with approximately ten years’ experience within Pharmacovigilance to head up this function and manage the team. The main focus of the role is to establish a Pharmacovigilance network within all operating countries and ensure uniform compliance and exchange of drug safety information within these Affiliates, Licensed Partners and CROs.

Responsibilities of the role include:

  • Supervision of security information on the management systems;
  • Oversee the product safety assessments processes;
  • Ensure training is provided throughout the Group on legislation and GPV requirements;
  • Enhance and manage the ADR system to ensure that all suspected cases are effectively collected, evaluated and centrally managed;
  • Ensure a prompt and comprehensive response to any requests for information from authorities;
  • Oversee the quality management system for GVP including quality assurance and control procedures, compliance monitoring, SOPs, training and audits.

The ideal candidate would have:

  • Degree in Medicine or PhD
  • Approximately 10 years’ experience in Pharmacovigilance/Drug Safety
  • Thorough knowledge of GVP, GCP, Epidemiology and Biostatistics
  • Strong leadership skills
  • Ability to plan and manage projects and set priorities for tasks within the division
  • Assertive communicators and good interpersonal skills
  • Knowledge in project management
  • Excellent English command both written and verbal
  • Willing to travel

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