Patient Safety Director - Sant Feliu de Llobregat, España - Almirall

Almirall
Almirall
Empresa verificada
Sant Feliu de Llobregat, España

hace 1 semana

Isabel García

Publicado por:

Isabel García

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Descripción

Date:23 Nov 2023


Location:
SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain


Company:
Almirall


Mission:

The director of patient safety at Almirall is accountable for:

  • Establishing and maintain a Global/Corporate Pharmacovigilance system that protects patients and users of Almirall medical solutions.
  • Acting as the EU Qualified Person for Pharmacovigilance (QPPV) and UK QPPV.

Education & Experience:


  • Life science degree (preferably MD) with high level of pharmacovigilance expertise (minimum of 10 years)
  • Knowledge of European regulatory requirements relating to PV
  • PV systems experience, GVP audits and regulatory inspections experience.
  • Proficient command in English, fluency in Spanish desirable
  • Team management experience

Tasks and Responsibilities:


  • Manages the Almirall Corporate Patient Safety Team and coordinate Safety activities for all Almirall products, both investigational and marketed products. Coordinates communication of safety issues both internally and to health authorities.
  • Directs the activities of CPS concerning the processing and optimal management of pharmacovigilancerelated safety information on Almirall products towards internal stakeholders (i.e headquarters, management, market companies) and external stakeholders (business partners, regulatory authorities).
  • Ensures proper safety surveillance of Almirall marketed products. Oversee ongoing and periodic review of safety information to detect and investigate safety signals in order to establish/maintain adequate safety profile for Almirall products; Recommends regulatory actions and risk minimisation measures as required.
  • Responsible for clinical safety aspects of development projects along with clinical department since first in man studies such as: safety monitoring, B/R balance assessment, periodic safety reports (eg. DSURs) management, SAE management and Risk Management activities.
  • Maintains compliance with patient safety legal requirements and international guidelines.
  • Ensures that there is quality management system in place suitable for Pharmacovigilance.
  • Is the European Union Qualified person responsible for Pharmacovigilance (EUQPPV) and UK QPPV.
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