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Medical Pharmacovigilance Expert

Jefferson Wells, on behalf of an Italian pharma company, is looking for a Medical Pharmacovigilance Expert.S/he will be responsible for the following pharmacovigilance activities, primarily (but not exclusively), assigned to her/him:

  • Medical review contribution to Serious Adverse Events (SAEs)/Individual Case Safety Reports (ICSRs) assessment, and Follow-up request together with other PV-Operations team members
  • Review of safety cases line listing (LL) and preparation of regulatory documents in accordance with ICH/GVP guidelines and company standards (i.e. PSURs, RMPs, Deficiency Letters, etc.)
  • Perform proactive and on-going signal detection and risk management assessments to ensure a positive risk-management for the Company's products.
  • Support to the development of risk management programs
  • Medical review and assessment of safety profiles for Corporate and Local Products, which include CCSIs, SmPCs, and any other product related information document.
  • Clinical evaluation of relevant scientific and medical literature
  • Report periodic compliance and performance metrics and KPIs to the line manager within the required timelines
  • Contribution to the preparation/update of PV standard operating procedures, working instructions and templates
  • Preparation of medical education programs to healthcare professionals
  • Support the Affiliates in the management of their local products, as appropriate (e.g. ICSR assessment, review/preparation of PSURs, RMPs).
  • Assist and participate in Pharmacovigilance audits.
  • Assist in Pharmacovigilance Inspection readiness activities.

Profilo

Main requirements:

  • Medicine Degree
  • Previous experience in the role
  • Fluent English

1 marzo 2022
Azienda
Experis
Categoria
Medica
Località
Bologna
Esperienza richiesta
Da 1 a 3
Tipologia contrattuale
Full Time
Lingue richieste
Inglese
Livello lingua
good
posizione chiusa
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