30 Jun 2014
28 Jul 2014
Amanda O'Connor
Full Time


  • Work as part of the Medical and Regulatory team working on EU and Rest of World territories for the P3 project.
  • Determine all products within the Company that require updates from a safety perspective
  • Medically and scientifically assess the relevant product information and
  • Utilise Company Core Safety Datasheets, medical and scientific references books and online literature searches, including summary of product characteristics (SPCs), patient information leaflets/literature (PIL) and Clinical Expert Statements (CESs) in compliance with:
  • Periodic Safety Update Reports (PSURs)
  • Harmonisation of SPC/PIL for different countries as per the regulatory requirements/variation
  • Annotate SPCs and PILs having a strong understanding of QRD/non-QRD requirements, System Organ Class (SOC) and MedDRA coding
  • Requests for Further Information from Regulatory Agencies
  • Analyse and justify safety data, making relevant updates and comparisons and presenting these to the team for agreement
  • Perform medical updates and support regulatory affairs to complete submissions to the local regulatory authorities
  • Collaboration with company medics and consultants for scientific advice
  • Work with an international-based team and be confident with communicating and collaborating with internal and external colleagues