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MEDICAL AFFAIRS EXECUTIVE

This job is no longer available

Recruiter
Real Staffing
Posted
30 June 2014
Closes
28 July 2014
Ref
RE-12527719
Contact
Amanda O'Connor
Location
Sector
Contract Type
Hours
Salary
Negotiable

Further information

Responsibilities:

  • 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 Staffing

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