Medical Assurance Professional

Purpose And Scope

• Support the development, implementation, and successful execution of the Medical Assurance objectives, supporting the overall PV Case Management, RAPV Operations and RAPV mission.
• Contribute to driving a globally aligned approach to ensure ICSR medico-scientific quality and consistency, to support the effective management of the safety profile of Astellas marketed and investigational products.
• Collaborate with vendor medical personnel, Astellas RAPV and non-RAPV colleagues to ensure, support and improve processes to deliver high quality medico-scientific assessments for ICSRs.
• Maintain processes and tools to support high quality medico-scientific assessment of ICSRs
• Lead projects to establish and utilise effective systems to house regulatory documentation and support tools relevant for medical assessment case processing activities (including but not limited to RSI, Medical Concept Library and EPTLs).
  

Responsibilities And Accountabilities

• Oversee daily management of the Medical Assurance mailbox by team members through triaging, direct handling and flagging/distributing urgent and routine requests to relevant team members. Correspondence includes but not limited to potential safety issues originating from ICSRs, new/updated reference safety information and associated documents, product trainings and any question/request from Astellas RAPV/non-RAPV stakeholders or vendor staff pertaining to the medico-scientific aspects of ICSR processes and tools.
• Contributes to global (cross-functional) process improvement initiatives and projects impacting medico-scientific aspects of ICSR reporting, medical support tools and associated activities, and actively participate in cross-functional teams to represent the medical voice of the RAPV Operations organization.
• Contribute to the creation, maintenance, and optimization of PV Case Management medical support tools to ensure quality and consistency.
• Ensure effective and timely maintenance of the Medical Concept Library and Expected Preferred Terms Lists (EPTLs) to support expectedness assessments
• Lead medico-scientific activities for the biannual (twice a year) MedDRA updates
• Perform Medical Assurance activities for the maintenance of product labelling for Astellas marketed and investigational products, including the Reference Safety Information for clinical trials/studies.
• Supports (un)planned non-conformances and CAPAs and global quality improvement initiatives associated with medico- scientific aspects of ICSRs and related activities.
• Undertake impact assessments of non-conformances affecting ICSR case processing for Medical Assurance, including collaborating with other RAPV and non-RAPV colleagues, as required.
• Support regular and ad-hoc training and medical education to internal and vendor medical personnel on medico-scientific aspects of ICSRs, support tools and associated processes.
• Ongoing review and maintenance of quality documents owned by Medical Assurance.
• Support inspection readiness activities for topics associated with in-house and outsourced medico-scientific aspects of ICSR case management.
• Other tasks, activities or projects assigned by line manager, as appropriate
  

Required Qualifications

• Minimum BSc degree in life sciences, or equivalent
• Minimum 2 years case processing experience (post-marketing/clinical trial) and expertise within Pharmacovigilance, including seriousness, expectedness and causality assessments.
• Minimum of 5 years relevant experience in pharmacovigilance or combined PV/RA/QA, and/or clinical development
• Good understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations.
• Good knowledge of MedDRA dictionary for coding activities.
• A technical expert within the organization, with extensive knowledge within their chosen specialty and developing knowledge of related disciplines. Has the ability to recommend enhancements to internal policies, processes and procedures based on new requirements, legislation, etc.
• Provides solutions to a wide variety of problems of greater complexity that require the regular use of creativity and ingenuity, while safeguarding compliance and quality
• Experience in quality and process improvement activities
  

Preferred Qualifications

• Medical/physician qualification
• Advanced Excel skills, including development/usage of formulas and macros
  

Working Environment

Astellas’ Global Capability Centres – Overview