Responsibilities

  • Ability to support the QPPV Line of Business
  • Ability to support in PV audit and inspection
  • Ability to take the role of France responsible person for Pharmacovigilance. (LRPPV)
  • Ability to take on EUQPPV and UK QPPV responsibilities: − Main contact and communication for health authority and the MAH. − Revison of PhV contract/SDEA − Monthly reconciliations with partners − Monthly surveillance of local Health Authority websites for identification of safety related data. − PSMF preparation, review and finalization − Technical agreement redaction/review

Education & Experience

  • Life sciences degree or Healthcare professional (Pharmacist, dentist, or medical degree is a plus)
  • 2-8 years of experience in Pharmacovigilance/drug safety
  • Experience in case management or medical information and literature or medical writing in English
  • Knowledge of the relevant European and French regulation and EU GVP
  • Experience as a deputy EUQPPV or working closely with the QPPV office would be an advantage

Skills

  • Ability to take on EU-QPPV and UK QPPV responsibilities
  • EU GVP and ICH/GCP understanding
  • Agility and analytical
  • Good interpersonal skills, team player and excellent communication skills
  • Ability to attend customer facing teams & F2F meetings
  • Proficiency in professional and technical Organization, initiative, anticipation and adaptability
  • French speaker and any other European language would be desirable

Publish Date

02 September, 2023

Spontaneous Application

Vigilance Specialist 961

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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