Vigilance Coordinator 463

ProductLife Group is looking for a Vigilance Specialist to join our dynamic teams as soon as possible and contribute to improve patient’s life.

About us

Group 10
Responsibilities

  • will be involved in QPPV role
  • writing of PV documents (PSMF, SDEA, PV SOPs,…) and PV training
  • will be facing the customer
  • deputy or working closely with the QPPV office would be an advantage
  • Audit and Inspection Participation experience
  • Check that all files are properly handled as the day progresses and ensure that the workload is reorganized as necessary
  • Ensure that all necessary information is disseminated to the relevant staff to ensure that the BU’s activities are handled correctly and within the required timeframe
  • Acts as a facilitator for the activity(ies) of the LoB he/she belongs to

 

Group 13
Profile

  • Ability to take on EU QPPV role & deputy roles
  • Decision-making and alert ability
  • Rigor, analysis and method
  • Proficiency in professional and technical Organization, initiative, anticipation and adaptability
  • Good interpersonal skills, team player and excellent communication skills
  • Ability to attend customer facing teams & F2F meetings
  • Ability to participate to clients audits and inspections

Technical Knowledge

  • 3-7 years of experience as a drug safety or Pharmacovigilance assimilated
  • Experience in case management (from collection to submission), RMP, SDEA, PSUR and Signal
  • Experience in Eudravigilance
  • Knowledge of the relevant EU regulations and GVP
  • Audit and Inspection Participation experience would be an advantage
  • Experience as a deputy or working closely with the QPPV office would be an advantage

Vigilance Specialist 506