Pharmacovigilance Officer
Creative Pharma Services S.A
Αθήνα, Ελλάδα
πριν από 16 μέρες
source : Kariera.gr

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, 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)

Main Responsibilities

The position lies within the Pharmacovigilance Department 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
  • Απαιτήσεις

  • Life sciences education and background (preferably in Medical sciences, e.g Pharmacy, Nursery Studies, etc) with minimum of 1 year of relevant experience in drug safety.
  • Excellent written and verbal communication skills, be fluent in English and have excellent knowledge of Microsoft office.
  • 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
  • Strong interpersonal, written and verbal communication skills in both English and Greek as well as demonstrated capability to problem-
  • solving and managing complex safety issues.

  • 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, and for that reason we invest in people’s potential and growth.

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