Act as the local quality assurance/quality system representative for the TSO;
Establish and maintain TSO Quality Management System and Quality Assurance activities to ensure compliance with all regulatory and GxP requirements;
Host/Coordinate audits/inspections on behalf of GxP functions within TSO;
Local supplier assessment and oversight including QTAs maintenance and local audits conduct;
Ensure Quality management review and KPIs are established;
Focuses on proactive crisis prevention and supports crisis (QSEB) and CAPA follow-up when needed;
Facilitate change;
Drive and support local and global initiatives on continuous quality improvement;
Drives remediation plan when a product quality or GxP process issue is identified;
Maintain and ensure local Product Complaints and recalls management;
Integrate global/corporate and TSO quality needs and priorities, including representing the TSO at the Ipsen Global Quality Forum;
Foster quality culture by encouraging best practices and a high performing “quality beyond compliance” culture, both from procedural and patient/customer centricity perspectives;
Contribute strongly to building quality and compliance through governance and education;
Participate on regulatory intelligence process and, where necessary, escalate with technical expertise, assessment and solution proposals;
Ensures comprehensive training program covering all GxP activities;
Ensure the TSO self-inspection, GxP audit readiness; business continuity, change control, Deviations and CAPA management systems and activities are in place and implemented to cover GxP processes;
Create the local standard operating procedures (SOPs) to handle all the pharmacovigilance activities to be compatible accordance with the regulation on the SFDA variations guidelines
Ensure all PV activities are delivered in line with local guidelines, legislation as well as local and global Ipsen Policies and SOPs
Act as the local PV contact for Ipsen Global Patient Safety (GPS)
Being involved in the causality assessment, seriousness of Individual Case Safety Reports (ICSRs). In addition, ensure the accurate, timely reporting and follow-up activities of all adverse events and special situations reports and have necessary translation and quality steps in place
Have translation capability
Ensure review of literature for collection of AEs and Safety Signals
Escalate any signals identified at local level or highlighted by local health authorities, and any emerging safety concerns
Compile monthly metric reports and perform weekly/monthly reconciliations for adverse events (internal and with external partners)
Having awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the products
Provide Pharmacovigilance oversight to the delivery of Risk Management Plans in conjunction with the cross-functional team and having a sufficient authority over its content, as applicable and ensure aRMMs are managed per global and local requirements
Ensure the correctness and completeness of pharmacovigilance data submitted to the SFDA
Ensure a full and prompt response to any request from the SFDA for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product
Provide Pharmacovigilance expertise into all areas of the business as required.
Ensure local Ipsen has a comprehensive local PV system
Work with the quality head for product complaints so that both product complaints and adverse event reports are handled in a compliant and customer service-oriented manner.
When requested, prepare and review accurate, high quality pharmacovigilance reports (aggregate safety reports and other ad hoc reports) and documentation, within agreed regulatory timelines, to assist in meeting local regulatory requirements, as required under the supervision of GPS, and/or country Leadership.
Support the business through the provision of drug safety expertise in the review and approval of activities such as Patient Support Programs and Patient Data Collection Systems
Act as the local contact for all Patient Data Collect Systems (PDCS):
Provide training and support with regards to PV requirements on PDCS’s to Ipsen colleagues
Assess program for eligibility and liaise with the GPS solicited team
Ensure all documentation is completed, PV training is provided, and that the Global Inventory is updated
Support and attend affiliate/GPS meetings to ensure awareness of any changes in global and/or regional requirements of the PV system.
Perform regular review of local regulatory requirements and best practices and inform the QPPV Office and/or GRA of any changes to local regulations that affect the reporting of safety data and associated reports. Escalate safety, compliance and operational issues to GPS in addition to the local Leadership.
Provide local reporting rules and review that they are appropriately set up in the global safety database.
Act as the pharmacovigilance contact for the SFDA 24/7, and be the contact point for any PV inspections
PV Cross-functional and oversight role
Liaise with all functions including Commercial partners, Service Providers, third parties, and other Ipsen functions like medical affairs, regulatory affairs, medical information etc. to have an overview of processes impacting PV affiliate workflows
Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare providers)
Demonstrate scientific and business expertise relevant to therapeutic areas, including roducts, disease state management, emerging therapies, and the competitive landscape
Maintain a working knowledge of internal and external medical information systems
Provide support to Medical Information and Product Complaint teams to ensure the receipt, management, follow up, and tracking of safety reports from all sources are forwarded to the Ipsen Global Patient Safety (GPS) Case Processing Center for entry into the global safety database.
Act as the PV contact for all Ipsen sponsored local clinical trials
Support clinical trials by reviewing study protocols and be involved on the sign-off to ensure inclusion of a system for timely collection and handling of safety information.
Handle adverse events associated with the trials and manage collection and reporting of all safety information
Provide GPS and local management with outcome reports on all safety related activities
Work with the legal team to ensure that all contracts with local third parties include the appropriate PV agreement or language
Maintain oversight of any local/global PV agreements in the region and collaborate in the review of such agreements as required. Maintain direct relationship with the third-party partner and be responsible for oversight of the implementation and maintenance of the safety exchange with the partner, including monitoring compliance.
Collaborate with Global Regulatory Affairs to confirm specific local requirements for aggregate reports (i.e. Regional specific appendices) and to ensure compliance
Coordinate with Global and local medical affairs on any ongoing studies
Provide information as required by or requested to support the maintenance of the EU PSMF
Training, Audit, Inspection and CAPA management role
Ensure that regular, documented audits of the local PV system take place
Coordinate and input into deviations and CAPAs (Corrective Action and Preventive Action) where necessary
Document and track deviations from PV processes and ensuring that appropriate CAPA are developed and implemented to address issues with compliance
Perform regular review of local Quality Documents such as SOPs and Instructions to ensure that they are compliant with GVP regulatory requirements and global Quality
Documents as well as local regulatory needs as applicable
Ensure that the PV team archiving is done in a timely fashion and in line with Ipsen SOPs and regulatory requirements
Partnering with Training to develop and update training programs and present to new hires
Ensure that all members of the PV team maintain an up-to-date Training Record
Ensure that pharmacovigilance training courses are provided and documented for internal and external staff such that all Ipsen affiliate staff are trained in compliance with local regulatory requirements and global/local SOPs for adverse event reporting on Ipsen products.
Coordinate and prepare regulatory authority PV inspections and internal affiliate country office audits and supporting the development of responses to findings.
Participate in inspections and audits and conducting audits as needed.
Work with the GPS and the country Leadership to ensure a PV Business Continuity Plan is in place and tested.
Collaboration with other Departments
Proactively advocate for quality processes across functions
Proactively identify areas for process improvement and mediate cooperation cross-functionally to effect and implement the Quality System;
Contribute towards stakeholder value by providing quality leadership and operational input towards affiliate strategic and tactical activities
Strengthen the risk management culture and support the update of the IPSEN Risk register;
Communication
To respect and apply the company rules (especially the confidentiality ones) and strategy in communication with media, authorities and health professionals;
To maintain membership of societies and professional organisations of interest to the company, according to local legislation and the Group’s guidance;
To act with all relevant authorities/entities, with a great sense of public relations, having in perspective an increased efficiency and recognition of Ipsen;
To maintain and develop positive and ethical interactions with relevant authorities;
To respect and apply the IPSEN ethical code;
To develop a deep knowledge of company products.
Thank you for considering Ipsen as an employer of choice. We wish you all the best with your application.
