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Lieu: Séoul, Seoul, Corée du Sud
ID de l'offre 12842309
Date de publication: 08/09/2019

Purpose of the Job

Performs Patient Safety function responsibilities in accordance with AZ Procedural Documents, international guidelines such as ICH and GCP, as well as relevant local regulations

Typical Accountabilities

  • Identifies and selects single cases on JASPER (web based tool for retrieving potential expedited reports) for the assessment regarding the need for reporting to the local regulatory authority, Ethics Committee and investigators, as required.
  • Prepares submission packages, as necessary, to ensure compliance with local regulatory for overall safety reporting.
  • Distributes reports in accordance with local regulations and the timelines stated in ‘Patient Safety Standards’, ‘Adverse Events in clinical studies’ and 8-P37-current version-X Periodic Safety Update Reports (PSURS) and Related Reports.
  • Maintains a current knowledge of AstraZeneca policies and procedures; Standard Operating Procedures (SOPs); ICH GCP; protocol and legislative requirements, as required.
  • Acts as local trainer for new MC Safety Specialists, as appropriate, and for other stakeholders
  • Maintains an accurate and up to date tracking log for submission dates and submission decisions for individual case reports, periodic reports and for any training conducted by the Patient Safety Manager, as appropriate.
  • Maintains up to date information on local authority contacts, reporting requirements, reference documents, marketed status of products in the country and local licensing agreements, as applicable.
  • Plans, prepares, follows up(& implement) regulatory required studies and local Risk Management Plan
  • Prepares agreements with CROs/institutions/investigators/External Service Providers.

Functional Capabilities

  • Good communication skill with internal & external relevant stakeholders
  • Good understanding of clinical development & study process
  • Demonstrated working knowledge of regulations and guidelines relevant to Good Pharmacovigilance Practice

Essential Qualification

  • Bachelors degree in medicine or science/healthcare related field
  • Experience in the pharmaceutical medical sector ( PV/PMS/RA preferred ) at least 3 years
  • Good medical knowledge of AZ therapeutic areas
  • Computer literacy and ability to learn and work with systems
  • Ability to form partnerships, build and maintain relationships
  • Excellent time management/Planning/Organisational skills
  • Good attention to detail
  • Excellent ability to prioritize and handle multiple tasks within strict timeframes
  • Team player
  • Excellent ability to work according to global standards
  • Ability to work independently

Desired skills or requirements

  • Good verbal & written communication skills (fluent in local language with at least Intermediate level of English)
  • Pharmacist preferred

Patient Safety Associate
Développement clinique

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