A brand new role,- based in CZ or SK, member of the cluster Medical Affairs Team, reports to Cluster Medical Director (CZ)
Main Tasks and responsibilities – Operational Vigilance Roles and responsibilities (CZ & SK)
- Perform regular review of National regulatory requirements and best practices and inform GPS of any changes to National regulations that affect the reporting of safety data and associated processes
- Ensure the accurate, timely reporting and follow-up activities of all safety reports and have necessary translation and quality steps in place
- Ensure to have translation capability
- Ensure review of local literature for collection of safety information and Safety Signals
- Work with the quality department for product complaints so that both product complaints and safety reports are handled in a compliant and customer service-oriented manner.
- Handle safety reports solicited from trials by managing collection and reporting of all safety information
Aggregate reports management
- 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 National regulatory requirements, as required, and under the supervision of GPS, and/or Cluster Leadership.
- Collaborate with Global Regulatory Affairs to confirm specific National requirements for aggregate reports (i.e., Regional specific appendices) and to ensure compliance with National regulations.
Main Tasks and responsibilities – Cross-functional and oversight role (CEA cluster wise)
Quality Management System maintenance
- Maintain the CEA Cluster vigilance Quality Documents up to date by performing regular gap analysis against Good pharmacoVigilance Practices (GVP) and national regulations as well as global Quality Documents
- Ensure all vigilance activities are delivered in line with national guidelines, legislation as well as local and global Policies and SOPs
- Document and track deviations from vigilance processes and ensuring that appropriate Corrective Action and Preventive Actions (CAPA) are developed and implemented to address identified issues
- Compile monthly metric reports and perform regular reconciliations for safety reports (with internal and external partners)
- Provide information as requested to support the maintenance of the EU PSMF
- Escalate any signals identified at Cluster level or highlighted by National Health authorities to GPS.
- Provide Pharmacovigilance oversight to the delivery of Risk Management Plans in conjunction with the cross-functional team, as applicable, and ensure Additional Risk Minimisation Measures (ARMMs) are managed as per global and National requirements
- Support the business through the provision of drug safety expertise in the review and approval of activities such Patient Data Collection Systems (PDCS)
- Act as the local vigilance contact for PDCS
- Act as the PV contact for all CEA Cluster sponsored clinical trials
- Support clinical trials by reviewing study protocols to ensure inclusion of a system for timely collection and handling of safety information.
- Coordinate with Global and Cluster medical affairs, and vigilance service providers as required on any ongoing studies
- Work with the legal team to ensure that all contracts with CEA Cluster third parties include the appropriate vigilance agreement/clause
- Maintain oversight of any local/global vigilance agreements in the region and collaborate in the review of such agreements as required.
- Maintain direct relationship with the third parties and be responsible for oversight of the implementation, maintenance and termination of safety exchange with the partner, including monitoring compliance.
- Exhibit excellence leadership skills to guide vigilance service providers staff
- Manage tenders for vigilance service providers in the CEA cluster
- Set up clear objectives and KPI for vigilance service providers through agreements
- Manage monthly compliance reports with vigilance service providers and commercial partners
- Manage invoices with vigilance service provider
- Partnering with training team 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 vigilance training courses are provided and documented for internal and external staff to ensure that all affiliate staff are trained in compliance with National regulatory requirements and global/CEA Cluster SOPs for safety information reporting on company products.
- Provide vigilance expertise into all areas of the business as required.
- Ensure seamless cooperation between external and internal stakeholders (Cluster, local and global)
- Liaise with all functions including Commercial partners, Service Providers, third parties, and other company functions like medical affairs, regulatory affairs, medical information etc. to have an overview of processes impacting vigilance workflows
- Support and attend GPS affiliate meetings to ensure awareness of any changes in global and/or regional requirements of the PV system
- Escalate safety, compliance and operational issues to GPS in addition to the Cluster Leadership.
- Provide reporting rules covering the CEA Cluster and review that they are appropriately set up in the global safety database.
- Ensure that the safety documentation is archived in a timely fashion and in line with company SOPs and regulatory requirements
Business Continuity Plan
- Work with GPS and the country Leadership to ensure vigilance Business Continuity Plans across the Cluster are in place and tested regularly.
- Ensure that regular, documented audits of the Cluster vigilance system take place
- Coordinate and provide input into deviations and CAPAs (Corrective Action and Preventive Action) where necessary
- Coordinate, prepare and participate in regulatory authority Vigilance inspections and internal audits in the CEA Cluster and support the development of responses to findings.