Purpose and Scope:Strategy Development and Execution Contributes to the implementation of 1–3-year Global, Regional Affiliate Management and Local specific objectives and plans as part of the overall PV strategy and plans. Supports in the successful execution and implementation of Global Affiliate Management vision, mission, objectives and plans. Provides input to PV leadership and strategic direction to the local PV dept in the country/affiliate. Coaching/mentoring of the local PV dept staff employees (if applicable).Responsibilities and Accountabilities:General department Executes processes and activities in which the PV department can contribute to the compliance, efficiency and overall effectiveness of the affiliate. Responsibility for executing locally new initiatives, management tools or processes in cooperation with PV-Affiliate Management Function. Provide support in ensuring that all affiliate PV staff have access to the necessary tools and systems. Effectively collaborates with the PV-Affiliate Management Function, the affiliate functions and the competent authorities. Ensure that processes, procedures and PV files are well documented in an up-to-date and complete archive i.e. ‘audit/inspection ready’ status.Management of Product Safety Information Ensures that safety information (Adverse Events) received fromallsources (e.g literature search, Market Research, Patient Support, Digital Media) by the affiliate are collected, translated and forwarded to designated Regional Global PV Headquarter, in compliance with required timelines (reporting timelines), quality guidelines and standards. Ensures that all Individual Case Safety Reports (ICSRs) are captured, tracked and managed in the applicable system(s) in accordance with applicable standards and procedures. Supports in monitoring caseload trends. Provide support for monitoring interactions with vendors that are used to conduct PV services Overseeing and monitoring compliance of case documentation Is responsible for ensuring the filing, storage and archiving of Product Safety Information in the electronic archive or paper-based archive Be aware of the system(s) in place for the handling and tracking of e.g., medical information inquiries and product quality complaints Is supporting reconciliation with other Astellas operating unit systems (e.g., Medical Information and TrackWise for Quality Assurance) and contractual partners, as applicable Supports the monitoring of vendors to which PV activities have been outsourced (If allowed by local regulations)PV Quality and Compliance Conducts assigned PV activities in alignment with regulatory requirements and internal Astellas procedures to ensure full compliance with Regulatory requirements. Supports the implementation of relevant updates to PV regulations (including maintenance reporting rules matrix), within the required timeline. Communicates any changes to PV Affiliate Management Function, EU-QPPV, the PV Regional HQ Office and/or other local business functions, as applicable. Executes PV activities in compliance with local and regional PV regulations and Astellas policies/procedures and take corrective and/or preventive actions, as appropriate and required. Supports the due diligence of potential new product acquisitions/local country licensing agreements if applicableMaintenance of PV System and Oversight Responsibilities Provides input for the PSMF regarding the affiliate communication to PV regional Head Quarters Supports in ensuring Astellas affiliate is GPvP inspection-ready: project management related to regulatory authority, business partner or internal inspections. Act as the main point of contact, and as such, coordinate regulatory authority inspections in collaboration with QA and PV: both announced and unannounced - as and when required. Supports in conducting PV self-assessments, PV audits/inspections at the affiliate and assist in developing CAPAs (with qualitative/quantitative measures and timelines) in response to findings/observations Contributes to the process of qualification of PV vendors is conducted and periodic audits are requested. Collaborates outsourced partners to ensure PV activities are conducted according to the relevant procedures Supports the establishment of contracts with Vendors and License Partners: subject to language ability. Performs activities of the Quality Management System (QMS), including QA and QC activities Supports the development and maintenance of locally applicable PV Quality documents. Ensure filing, storage and archiving of PV documentation in accordance with PV regulations and with Astellas policies and procedures. Requests to have access to, and be aware of, the affiliate business continuity plan (for example system failure and other disasters) in relation to PV activities. Responsible for ensuring a local mechanism is in place for 24/7 availability to enable appropriate handling of potential urgent safety issues by the affiliate. Contributes to the oversight and monitoring of all local studies and projects, including digital media and Astellas sponsored websites that impacts PV. Supports in the development of safety monitoring and reporting plans for clinical trials that impact the affiliate. Ensures local post-marketing programs (e.g. Post Authorization Studies [PAS], Post Authorization Programs [PAP] or market research, post marketing surveillance [PMS]) protocols are reviewed for compliance with PV requirements, as applicable. Participates in local activities concerning Risk Management Plans and Risk Minimization Measures and support the implementation activities. Provides support in ensuring local initiatives such as company sponsored websites and other digital media, registries, and marketing initiatives are reviewed for compliance with PV requirements and Astellas PV procedures.Training Provides the annual delivery, and documentation of PV Product Safety Awareness training to Affiliate (e.g., Medical Information, Sales Rep, receptionists). Also, where applicable, to third party personnel providing PV-related services, and to other staff within the territory. Supports the maintenance of local PV Training Role MatrixQuality Assurance Maintain the Quality Management System: implementation and continual improvement of QM systems, procedures, and processes, i.e.: handling of deviations, complaints and CAPAs, handling of GMP/ GDP regulated changes or escalation of potential significant quality issues. Ensure that deviations and complaints, as identified at the affiliate are raised in TrackWise and TrackWise digital, are appropriately investigated and CAPA plans are developed where appropriate. Ensure deviations, complaints, CAPAs and change control actions are progressed in a timely manner. Maintain the training system for all personnel involved in wholesale dealer and/or MAH activities and perform training of the relevant Quality Management Systems. Perform local checks following receipt of certified medicinal product according to a documented process and execute the local “Release for Distribution” for products in accordance with local regulations and guidelines. Check and prepare quality agreements with local country third parties in accordance with internal and external regulations. Perform audits of local country third parties, as appropriate. Conduct self-inspections according to the approved self-inspection plan. Ensure local GMP / GDP procedures are maintained in the Astellas Document Management Systems. Ensure that only approved Local Service Providers are used, if applicable. Collaborate with LSPs to ensure Quality Assurance requirements are followed and maintain appropriate QA oversight for GDP operations and warehouse management. Properly document changes with potential impact on GDP/GMP compliance and implement the changes in timely manner. Perform validation activities for local GDP / GMP systems, as required. Review the Product Quality Review reports in a timely manner. Support SQI investigation and recalls. Prepare for GDP/GMP Inspections by Competent Authorities and assist the Quality Assurance Lead & Responsible Person during these inspections. Prepare and respond QA Internal audits Prepare and approve monthly KPI report and submit the KPI report to the QA Sub-region lead.Required Qualifications:Minimum BA/BS (Pharmacy, Medical or Biomedical/Life Sciences preferred) preferably with an advanced professional degree Track record of demonstrable and relevant minimum 3 years’ experience within PV and/or combined PV/RA/QA; to include direct contact and engagement with national competent authorities. 1 Year people/project management experience preferred. Good understanding of establishing and maintaining (GxP) Quality Management Systems. Awareness of local industry code(s) of practice and local and/or regional PV regulations and guidelines. Experience in supporting a PV system in at least one single country; low complexity, low case volume. Awareness and experience with some aspects of a PV quality management system Proficiency in local language and business English language (written, verbal, presentation, facilitation)
Job Title
PVQA Manager