Responsibilities

  • Act as local safety officer/ local QPPV / local PV representative for MAH products in the territory.
  • Main contact and communication for health authority and the MAH.
  • Nomination of the details with the local health authority
  • Participation in audits
  • Revison of PhV contracts
  • Monthly reconciliations with partners
  • Weekly or monthly (depending on the frequency of publication)surveillance of local journals
  • Monthly surveillance of local Health Authority website for identification of safety related data.
  • Answering calls from the patients/consumer/partners
  • PV mailbox management
  • Local case management activities, including translation and follow-up of PV cases in local language
  • Able to support QPPV and take back-up QPPV role

Education & Experience

  • Science degree, Ph D, Healthcare professional (Nurse, dentist, Pharmacist or medical degree)
  • 0-6 years of experience in Pharmacovigilance/drug safety
  • EU GVP and ICH/GCP understanding
  • Experience in case management or medical information and literature or medical writing in English
  • Knowledge of the relevant local regulation and EU GVP

Skills

  • Czech and Slovak or additional EU languages
  • Agility and analytical
  • 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

Publish Date

06 September, 2023

Spontaneous Application

Vigilance Specialist 978

New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.

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