Η θέση Senior Pharmacovigilance Officer έχει αποθηκευτεί.

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GR
αποτελέσματα
Πλήρης Απασχόληση
Chalandri

Περιγραφή Θέσης

Creative Pharma Services SA is a client-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 outcome-oriented, 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:

Senior Pharmacovigilance Officer

Main Responsibilities


The jobholder will be part of the Pharmacovigilance Team and general duties include:

  • Support 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
  • Manage 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
  • Respond 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
  • Provide 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

Απαραίτητα Προσόντα

  • Life sciences education and background (preferably in Medical sciences, e.g Pharmacy, Nursery Studies, etc) with minimum of 2 years of professional experience in drug safety and CRO/ Pharma Industry.
  • Excellent written and verbal communication skills, fluency in English and Microsoft office applications.
  • 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, effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective.
  • 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 fast pace and client-oriented environment


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 collaboration and team-work, and for that reason we invest in people’s potential and growth.

By sending your CV to us you accept our “Privacy Statement and Terms for submitting your Curriculum Vitae”, which is available at http://www.creativephs.com/en/data-protection-policy


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