Manager, Global Aggregate Reports quality and compliance

Found in: Talent UK C2 - 7 days ago

Maidenhead, United Kingdom CSL Full time

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.

Our Benefits

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives.

  • Manager, Global Aggregate Reports quality and compliance

    Found in: beBee S GB - 2 weeks ago

    Maidenhead, United Kingdom CSL Full time

    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...

  • Manager, Global Aggregate Reports quality and compliance

    6 days ago

    Maidenhead, Berkshire, United Kingdom CSL Seqirus Full time

    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. Be one of the first applicants, read the complete overview of the role below, then send your application...

  • Manager, Global Aggregate Reports quality and compliance

    Found in: Adzuna UK C2 - 7 days ago

    Seqirus UK - Maidenhead, SL6 8AD, Maidenhead, United Kingdom CSL Seqirus Full time

    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...

  • Medical Writing Manager(Regulatory experience required)

    6 days ago

    Maidenhead, Berkshire, United Kingdom CSL Seqirus Full time

    The Manager, Global Aggregate Reports Quality and Compliance is an integral member of the Global Aggregate Report office and PV Writing Organization. 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., Coordinates the Aggregate...

  • Quality Document Manager

    4 days ago

    Maidenhead, South East, United Kingdom Randstad Tech IT Full time

    Are you an experienced Quality Document Manager? Or, do you have a background in Medical Writing? If so, our Biotechnology client is looking for individuals just like you! The successful candidate will perform quality review to ensure documents authored by the Safety Surveillance and Aggregate Reports team or their vendors are of high quality and support...

  • Compliance Support Manager

    6 days ago

    Maidenhead, United Kingdom The Rank Group Full time

    **Company Description** The Rank Group is a Venues and Digital gaming businesses. If you’re not sure who we are, you may be more familiar with us through our venue brands; Mecca Bingo and Grosvenor Casino. We employ circa 8,000 people globally, with our UK office functions being located in Maidenhead (Head Office), Sheffield (Customer Solutions Hub),...

  • Executive Assistant Global Head of Quality

    Found in: Talent UK C2 - 7 days ago

    Maidenhead, United Kingdom CSL Full time

    This role will provide high quality, efficient, administrative support to the Global Head, CSL Quality (CSL Seqirus and Enterprise Functions) and the Quality Leadership Team. You will maintain a strict sense of professional ethics, ensuring confidentiality and privacy and abiding by Company policy. The Quality Leadership team are located globally. To...

  • Financial Reporting Manager/Senior

    2 days ago

    Maidenhead, Berkshire, United Kingdom Hays Accountancy and Finance Full time

    Financial Reporting Manager/SeniorMaidenhead, UK Permanent, Full-Time Our client is a leading accountancy practice in Maidenhead dedicated to delivering exceptional financial services to our diverse client base. They are seeking a highly skilled and experienced Financial Reporting Manager/Senior to join their financial reporting team. The successful...

  • Quality Assurance Manager

    Found in: Talent UK C2 - 7 days ago

    Maidenhead, United Kingdom Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Senior Financial Reporting Manager

    2 days ago

    Maidenhead, Berkshire, United Kingdom Hays Accountancy and Finance Full time

    Financial Reporting Manager/SeniorMaidenhead, UK Permanent, Full-Time Our client is a leading accountancy practice in Maidenhead dedicated to delivering exceptional financial services to our diverse client base. They are seeking a highly skilled and experienced Financial Reporting Manager/Senior to join their financial reporting team. The successful...

  • Manager/Quality Manager

    Found in: Jooble UK C2 - 2 weeks ago

    Maidenhead, Berkshire, United Kingdom Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. We are looking for a full...

  • Manager/Quality Manager

    2 weeks ago

    Maidenhead, Berkshire, United Kingdom Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. We are looking for a full...

  • Medical Writer

    7 days ago

    Maidenhead, United Kingdom Randstad Tech IT Full time

    Are you an experienced Quality Document Manager? Or, do you have a background in Medical Writing? If so, our Biotechnology client is looking for individuals just like you! The successful candidate will perform quality review to ensure documents authored by the Safety Surveillance and Aggregate Reports team or their vendors are of high quality and support...

  • Global Health and Safety Advisor

    7 days ago

    Maidenhead, United Kingdom Irwin and Colton Full time

    **Global Health and Safety Advisor Maidenhead (Home working 3 days a week) | £40,000 to £50,000 + Excellent Benefits** Irwin and Colton are pleased to have been engaged by the Commonwealth War Graves Commission to recruit a Global Health and Safety Advisor. The Commonwealth War Graves Commission is an intergovernmental organisation providing an...

  • Global Export Coordinator

    10 hours ago

    Maidenhead, United Kingdom Seqirus Full time

    Reporting to the Global Logistics Manager, the Global Export Coordinator will manage and track the progress of all export and import shipments end to end and ensure accurate and timely filing of required documentation. This individual will manage import and export documents (e.g. permits, EUR1s, COO, POAs, etc.) to meet HMRC custom audits, maintain files and...

  • Global Export Coordinator

    10 hours ago

    Maidenhead, United Kingdom Seqirus A CSL Company Full time

    Reporting to the Global Logistics Manager, the Global Export Coordinator will manage and track the progress of all export and import shipments end to end and ensure accurate and timely filing of required documentation. This individual will manage import and export documents (e.g. permits, EUR1s, COO, POAs, etc.) to meet HMRC custom audits, maintain files and...

  • Supply Chain Quality Associate

    Found in: beBee S GB - 2 weeks ago

    Maidenhead, United Kingdom Proclinical Staffing Full time

    Supply Chain Quality Associate - Maidenhead, England - PermanentProclinical is seeking a dedicated QA Associate for our Supply Chain Quality Assurance team. This is a permanent position located in Maidenhead, England. Primary Responsibilities:The primary focus of this role is to work with internal and external stakeholders to ensure the timely release of...

  • Supply Chain Quality Associate

    Found in: Talent UK 2A C2 - 2 weeks ago

    Maidenhead, United Kingdom Proclinical Staffing Full time

    Supply Chain Quality Associate - Maidenhead, England - PermanentProclinical is seeking a dedicated QA Associate for our Supply Chain Quality Assurance team. This is a permanent position located in Maidenhead, England.Primary Responsibilities:The primary focus of this role is to work with internal and external stakeholders to ensure the timely release of...

  • Supply Chain Quality Associate

    Found in: Appcast UK C2 - 2 weeks ago

    Maidenhead, United Kingdom Proclinical Staffing Full time

    Supply Chain Quality Associate - Maidenhead, England - PermanentProclinical is seeking a dedicated QA Associate for our Supply Chain Quality Assurance team. This is a permanent position located in Maidenhead, England.Primary Responsibilities:The primary focus of this role is to work with internal and external stakeholders to ensure the timely release of...

  • Supply Chain Quality Associate

    Found in: Appcast UK C C2 - 2 weeks ago

    Maidenhead, United Kingdom Proclinical Staffing Full time

    Supply Chain Quality Associate - Maidenhead, England - PermanentProclinical is seeking a dedicated QA Associate for our Supply Chain Quality Assurance team. This is a permanent position located in Maidenhead, England.Primary Responsibilities:The primary focus of this role is to work with internal and external stakeholders to ensure the timely release of...