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Pharmacovigilance Officer

  • Creative Pharma Services S.A
  • Αθήνα
  • 22/9/2017

Στοιχεία αγγελίας

Σχέση απασχόλησης - Πλήρης ΑπασχόλησηΕλάχιστη Απαιτούμενη Εκπαίδευση - ΑΕΙΑπαιτούμενη Προϋπηρεσία - Τουλάχιστον 1 έτος/ηΚατηγορίες - Επαγγέλματα Υγείας, Επιστήμες

Περιγραφή

Creative Pharma Services SA is a customer oriented Contract Research Organization offering services to the Pharmaceutical, Biotechnology and Medical Devices Industry. Our mission is to meet customer needs, while maintaining strict confidentiality and professionalism.

The quality of our people is the cornerstone of Creative Pharma Services. Our Team consists of passionate, outcome-oriented, collaborative, innovative, enthusiastic and with outstanding academic background people and that is our greatest asset. Due to our constant growth we are currently seeking for a:

PHARMACOVIGILANCE OFFICER (PV Officer)

 

The position lies within the Pharmacovigilance Department and general duties include:

  • Supports the Pharmacovigilance Manager in the performance of drug safety related duties.
  • Records, screens and categorises reports of adverse drug reactions in post marketing environment and clinical studies.
  • Coordinates tracking and evaluation of adverse drug reaction reports.
  • Compiles and submits reports on cases of suspected adverse drug reactions to authorities in accordance with applicable regulations.
  • Manages case-related information including interpretation of medical conditions, lab results, and procedures as well as compile complete narrative summaries; and ensure proper coding (MedDRA) into the global safety database.
  • Reports adverse events to internal sources and external regulatory authorities.
  • Screens local literature for expediting safety reports.
  • Generate documentation required for regulatory authorities.
  • Responds to inquiries from health care professionals, consumers, and company personnel regarding safety issues with marketed products.
  • Prepares periodic reports, aggregate safety reports, and safety analyses.
  • Provides drug safety guidance and training to our clients’ employees.
  • Ensures adherence to SOPs and other process documents.
  • Maintains and uses Pharmacovigilance Database and other relevant data collection tools.
  • Ensure procedures in relation to safety monitoring are being adhered to regulatory requirements.

Απαιτήσεις

  • Life sciences background with minimum 1 year of relevant professional experience in drug safety.
  • A thorough understanding of the global PV regulatory environment with working knowledge of ICH guidelines, EMA/CHMP regulations and guidelines, and other international regulatory requirements, a working understanding of drug safety databases.
  • PC literate and fluent in English.
  • Excellent written and verbal communication skills.
  • Ability to work effectively as an individual contributor and as a project team member.
  • Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
  • Willingness to work in a matrix environment and to value the importance of teamwork.


What we offer 


Creative Pharma Services is offering a competitive remuneration package according the Industry’s standards. Nonetheless, we are also proud at Creative Pharma Services that we are an open and learning organization that fosters a collaborative, enthusiastic, fast paced working environment, but also an employer that invests in people’s potential and growth.

All applications will be treated fairly and with strict confidentiality.


Περιγραφή Εταιρίας