The Manager, Global Aggregate Reports Quality and Compliance is an integral member of the Global Aggregate Report office and PV Writing Organization. The position holder responsibility includes the entire CSL product portfolio and development pipeline.
Responsibilities include: -
- Acts as a Regulatory Intelligence Triage Manager, responsible for driving initial assessment of regulatory changes related to Safety Sciences in alignment with functional Leads (e.g., Signal detection processes, aggregate reporting processes and templates, literature surveillance) based on comprehensive review of new and evolving pharmacovigilance legislation within the GRIP process.
- Coordinates the Aggregate Reports Quality Review Board and overseeing Aggregate report KPIs across CSL business units.
- The authoring of high quality regulatory required aggregate reports including scientific analysis and presentation of safety data which is a key contribution for successful product registrations.
- Acts as a Regulatory Intelligence Triage Manager, responsible for driving initial assessment of regulatory changes related to Safety Sciences in alignment with functional Leads (e.g., Signal detection processes, aggregate reporting processes and templates, literature surveillance) based on comprehensive review of new and evolving pharmacovigilance legislation within the GRIP process.
- Coordinates the Aggregate Reports Quality Review Board and overseeing Aggregate report KPIs across CSL business units.
- Acts as a Triage Manager, performs impact assessments of evolving pharmacovigilance legislation and regulatory guidance in safety sciences, e.g., aggregate reporting, literature review, signal detection / signal management (GRIP Process), assign to different functional representatives based on the impact within GRIP process and if required, seek input from functions outside of safety sciences
- Reviews and communicates all regulatory changes that may have an impact on areas within safety sciences to all relevant stakeholders for further implementation, if required
- Provides status of implementation of regulatory changes to Head of safety sciences and Team Leads in safety sciences following alignment with functional SMEs.
- Collaborate with relevant QPPV function within GCSP for further coordination of input to upcoming regulatory changes through Health Authority Consultation Reviews within safety sciences.
- Acts as a SME for quality and regulatory compliance for Aggregate reports.
- Support on Aggregate Reporting Quality Review Board meeting: oversee HA responses to CSL aggregate reports, ensure compliance with HA commitments in the area of aggregate reporting, adapt processes to HA requirements to continuously ensure CSL aggregate reports of highest quality, supporting smooth product registration in all countries where CSL markets its products., including organization and running of Quality Review Board Meetings, definition of KPIs and proposal of measure for continuous improvement of the quality of CSL Aggregate Reports based on Health Authority feedback.
- Acts as a SME for Quality oversight in preparation and conduct of audit and inspection, including interviewee and CAPA management.
- Acts as a CAPA owner for any findings from audit/inspections in Trackwise.
- Support inspection readiness of Global Aggregate Report office and PV Writing function.
- Acts as subject matter expert for audits and Health Authority inspections and in case of findings, performs root cause analysis and management of CAPA for Global Aggregate report office.
- Support developing, maintaining, and overseeing the key performance indicators for vendors based on the governance documents.
- Quality Review of aggregate reports to ensure consistent high quality of CSL aggregate reports across the entire portfolio.
- Acts as a vendor management contact back-up.
- Attend operational meetings with vendors, as required.
- Mentors and trains newer members of the team as well as contributing functions (e.g., CSS, GPRO, Regulatory, L-QPPV/SO)
- May act as PV Trainer for service providers in Global Aggregate Report office
- Interface Management
- Global cross-functional collaboration with all relevant interfaces, e.g., Case Management, Regions and SO / L-QPPV network, CSS & GSL, GRA, Medical Affairs, Commercial Development, Clinical Development
- Integrations Support Integrations of Global Aggregate Report office and PV Writing function processes, templates, and principles, e.g., in the frame of mergers and acquisitions
Qualifications, Skills, and Experience:
- University Degree (Diploma or MSc) in a life science (e.g., MD, PharmD, biology, nursing, nutrition), Quality, Medical Records management, or related area with relevant experience
- Other degrees (e.g., BS, BA) and certifications considered if commensurate with related Pharmacovigilance experience
- Significant experience in PV across all key PV processes
- More than five (5) years of relevant pharmaceutical / biotechnology industry experience, of which at least four (3) should be in a Pharmacovigilance role, ideally in safety sciences and related to aggregate reporting and PV writing and/or vendor management and PV quality.
- Experience in writing and QC of GxP relevant documents (technical writing, medical writing)
- Expert Knowledge of international GxP regulations and PV processes.
- A comprehensive understanding of pharmacovigilance, clinical development, and post-marketing safety requirements, including the regulatory safety documents required at each stage.
- Experience in CAPA management as well as writing of SOPs and maintenance of templates.
- Experience in working with relevant software applications (Office, SharePoint, Databases)
- Experienced in regard to GxP Training and Training Systems.
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