Nivel cariera

Senior (5-10 ani)

Limbi vorbite

engleză

Adresa/ adresele jobului

București


MAIN RESPONSABILITIES

  • Maintaining and coordinating the pharmacovigilance system;
  • Overview of all processes and procedures that are in place in pharmacovigilance department (ICSR, PSUR, CCSI, Evaluation of the need to prepare RMP);
  • Overview of compliance in relation to the quality, completeness and timeless of PSURs and ICSRs;
  • Implement the corrective actions related to pharmacovigilance inspections and audits;
  • Provision of the competent authorities of important information regarding the benefit-risk assessment for Alvogen products;
  • When needed initiate variations of urgent safety restrictions;
  • Acting as contact point for Pharmacovigilance inspections;
  • Makes sure that all relevant employees are trained in relation to pharmacovigilance activity;

CANDIDATE REQUIREMENTS

  • Knowledge of EU pharmacovigilance regulations
  • Previous experience in a global PV position
  • Proven experience as PV Manager at least 5 years
  • Previous experience with PV inspections and audits
  • Previous experience of ICSR, PSUR, CCSI, RMP
  • English language - advanced level both speaking and writing; good understanding of medical English terms is a must
  • Ability to prioritize, delegate and decide
  • Excellent communication and leadership skills
  • Proactive, open minded

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