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Pharmacovigilance Officer - ELPEN

ELPEN Pharmaceutical Co. Inc., a Greek Pharmaceutical Company, is seeking a Pharmacovigilance Officer.

Responsibilities:

The role will be responsible for handling and supporting internal Pharmacovigilance processes as part of Pharmacovigilance team. Pharmacovigilance officer directly reports to Pharmacovigilance Manager and QPPV and has close collaboration with Company’s departments as: Regulatory Affairs, Clinical Operations, Medical Affairs, Quality Assurance and others.
More specifically, the role:

  • Update and creation of Standard Operating Procedures
  • Handling of any reported adverse event: receipt, recording, follow-up and submission to Eudravigilance & Competent Authorities
  • Maintenance of PV database
  • Filing & archiving any PV-related document
  • Conduct reconciliation PV activities (internal & external)
  • Monitoring & administrative implementation of PV legislation
  • Monitoring & timely implementation of any decisions/recommendations derived from
  • Committees, European Medicines Agency, European Commission and Health Authorities
  • Identification and notification of any deviation to PV Manager
  • Administrative support in audit/inspection preparation
  • Communication with Authorities
  • Communication with other companies/third parties
  • Operating Eudravigilance
  • Operating Internal Data Management System

Education (minimum/desirable)
Minimum requirements

  • University Degree in Health Sciences, preferably in Pharmacy.
  • Minimum 1 year of experience in Pharmacovigilance of Medicinal Products for Human Use.
  • Very good knowledge of EU Pharmacovigilance legislation.
  • Familiar with Eudravigilance Environment
  • Excellent interpersonal skills and ability to work as part of a cross functional team.
  •  Excellent use of Microsoft Office.

Languages

  • Excellent or Fluent command of English (oral & written)

If you want to apply for this position please send your CV to the email Αυτή η διεύθυνση ηλεκτρονικού ταχυδρομείου προστατεύεται από τους αυτοματισμούς αποστολέων ανεπιθύμητων μηνυμάτων. Χρειάζεται να ενεργοποιήσετε τη JavaScript για να μπορέσετε να τη δείτε. with the indication “PV02”.

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