The incumbent is assigned to support one of three functional areas within Global PV Process Global Management, and may participate in assigned projects that can span more than one PV Process functional area:
A: GPV Process Global Management Governance support
- Responsible of administration of global PV process sharepoint(s) to ensure up to date and effective information sharing
- Interact with other functions within and outside of Global PV Process to prepare and maintain supporting documentation for outsourced activity, e.g. SAE reporting plans, reconciliation plans, Therapeutic Area conventions, training materials
- Triage questions from within GPV and ensures questions are routed to appropriate functions and follow up through resolution
- Contributes to or executes projects related to process improvements independently as directed. Projects are more complex, relative to the incumbent’s knowledge and abilities. Guides the completion of programs and may have a project leadership role.
- Coordinate and execute Safety Data Exchange Agremeents implementation activities in collaboration with PV process regional staff
- Responsible for maintaining expert knowledge processes and procedures for case processing and other PV Process activities
- Deliver PV process training to internal and external (vendor) staff, maintain training records
- Liaise with PV process compliance manager to perform investigations for e.g. late case
- Support updates to SOPs/WPDs , liaise with other relevant functions to facilitate process updates
- participate in assigned projects
- Act as Subject Matter Expert in audits and inspections for assigned subjects
- Maintain project documentation, meeting minutes, etc.
B: Vendor support - Support of all Vendor management activities in Global Vendor Management group, coordinate with PV process regional staff as needed
- Support daily interactions with global outsourcing vendors and license partners by routing questions to the relevant function and follow up through completion
- Responsible for maintenance of sharepoint site for GVM group
- Interact with relevant functions to ensure maintenance and support for outsourcing activities, including availability of relevant project documentation (training materials / matrixes, checklists, meeting minutes, TA conventions, etc.)
- Support global vendor management with oversight and guidance for additional Astellas vendors, including Clinical vendors
- Responsible for maintenance of calendar of planned and recurrent activities such as clinical study reconciliation, partner reconciliation, clinical database lock, end of study unblinding etc to enable accurate resource planning both internally and by the vendor
- Coordinate generation of listings etc for partner and Product Quality Complaint reconciliation with relevant groups (PVIM, trackwise administrator etc) and ensure documentation of periodic reconciliation completion by vendor and partner
- Assist in analysis of Key Performance Indicators, relevant metrics for outsourced activities and report to Ass. Director Vendor Manager - Liaise with PV Process Compliance manager to track and ensure compliance with CAPA - Liaise with PV Process Compliance manager for relevant deviations pertaining to case processing activities as executed by the vendor(s)
- Assist with necessary analysis including metrics, financial, budgetary, forecasting, case volumes, etc to support Vendor Management function
C: GPV Process Global Medical Expert support
- Coordinate and ensure accurate administration of bi-annual MedDRA upgrades of Expected Preferred Term Lists and Aways Serious Terms list
- Coordinate and ensure accurate administration of monthly Reference Safety Information maintenance process
- Coordinate and ensure accurate administration of periodic and ad hoc PT list updates with Global Medical Expert, Product Responsible Person, vendor and PV-Information Management
- Coordinate and ensure accurate administration of periodic and ad hoc AST list updates with GME and PVIM
- Responsible for administration of global PV process sharepoint(s) to ensure up to date and effective information sharing
- Support maintenance and coordination of product training materials, Therapeutic Area conventions, etc.
- Coordinate review of product related materials with Global Medical Expert and Product Responsible Person
Wat we bieden
Wat we bieden
Fulltime job in an international environment;
Good working conditions;
Salary: €3000-€4200 (based on working experience);
Flexible about opportunity working from home.
Minimum BA/BS in life sciences
Minimum of 2-3 years relevant experience in pharmacovigilance or combined PV/RA/QA, and/or clinical development
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 Astellas' compliance.
Self directed within the scope of his/her duties and responsibilities
Contributes to or completes projects independently as directed
Extensive PV knowledge
Experience with safety database
Over het bedrijf
Over het bedrijf
This company it an international pharmaceutical company positioned all over the world, this job is recuired in Leiden.