Group 10
Responsibilities

  • Ensuring on behalf of clients the positions of Pharmacovigilance responsible person/National contact person, such as (but with no limitation):
    • UK QPPV
    • UK National Contact Person
  • Ensure the follow-up and continuity of service for the activities inherent to the vigilance responsibilities delegated to PLG
  • Carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports for the clients delegating the responsibility of vigilance to PLG
  • Ensure the drafting / revision of all the quality document inherent in the vigilance responsibilities delegated to PLG employees, including and not limited to
    • Vigilance training support
    • Pharmacovigilance System Master File (PSMF)
    • Safety Data Exchange Agreement (SDEA) / Pharmacovigilance Agreement (PVA)
    • Vigilance procedures/ Standard operating procedures
    • PV training presentations both internal and external
  • Coordinate and ensure meetings with customer representatives in the context of responsibility delegation shoulder by the staff member himself
  • Represent the appointed PLG staff members during meetings with client if they are not present
  • Analyse the informative documents provided by customers in the context of the Responsibility delegation and send it to the PLG staff member namely appointed if not oneself
  • Review and approve the documents related to the assessment of the risk benefit balance of the products (PSUR type, signal management report, etc.) for the portfolios for which the responsibility is entrusted to a PLG employee and send it to the PLG staff member namely appointed if not oneself
  • and support to local QPPV/contact person on assigned projects
  • Help drafting the specifications for the part of the activities supported
  • Contribute to the establishment of the quality control system for the tasks performed, the monitoring of results and propose improvement actions
  • Help guarantee the regulatory compliance of client laboratories through, among other things, regulatory monitoring.
  • Participate in audits / inspections and resulting action plan

Group 10
Skill

REQUIRED TRAINING (S):

  • Life sciences degree (vigilance or medical is a plus)

REQUIRED SKILLS) :

  • 3-7 years of experience as a drug safety officer or assimilated
  • Experience in case management (from collection to submission)
  • Knowledge of the relevant UK regulations
  • Decision-making and alert ability
  • Rigor, analysis and method
  • Proficiency in professional and technical English
  • Organization, initiative, anticipation and adaptability
  • Audit and Inspection Participation experience
  • Experience deputy or working closely with the QPPV office would be an advantage

Vigilance Specialist 416