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- 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
Real is a global leader in the provision of pharmaceutical, biotechnology and medical devices recruitment services.