For one of our clients (East-Flanders), we are urgently looking for a senior PV operations specialist.
This is a temporary position, also open for freelancers!
The Senior PV operations specialist is involved in or fully responsible for directing the training and quality/compliance efforts for Drug Safety/Pharmacovigilance. You are responsible for working with management to ensure effective quality oversight, art 57 compliance and training activities. You are responsible for creating and delivering training, as well as providing ongoing feedback related to quality of services and compliance with regulatory guidelines, with critical attention to addressing issues with solution-oriented proposals.
Management of reconciliation activities with all data sources providing safety information to Global Drug Safety (GDS), e.g., Business Partners and Internal Stakeholders to GDS to ensure compliance. Reconciliation activities include:
• Standard operating procedures (SOPs)/work instructions (WIS) documentation of reconciliation process and maintenance of documents
• Follow-up to ensure 100% reconciliation, communication with the data sources for issue resolution, documentation of all activities
• Monitoring of timeliness of reconciliation files and necessary follow-up
• Create and track monthly metrics and trends from each of the for missing reconciliation cases & Manage corrective and preventative actions
• Provide monthly metrics on all reconciliation processes
• Establish and implement tools and processes, in close collaboration with other functions within GDS, to identify and monitor compliance and quality metrics for GDS, PV license partners and vendors for outsourced PV activities.
• Ensure continuous monitoring on compliance, timeliness and quality metrics, including detected patterns and trends, in close collaboration with internal (other GDS functions and EU-QPPV) and external stakeholders (GRA, GQA, affiliates, license partners)
• Monitor compliance with inspection/audit response commitments and effectiveness checks.
• Facilitate the Management Review process related to key performance indicators for global PV processes.
• Supports the maintenance of the PSMF in collaboration with the EU/Deputy QPPV with regards to QMS processes, Compliance Metrics and KPIs.
• Contribute to the development and ensure implementation of global best practices in Process Improvement Management in close collaborations with the GDS functions, GQA and relevant global stakeholders.
• Ensure the systemic identification of Quality Risks (trends and patterns), in close collaboration with the business subject matter experts.
• Conduct regular internal assessments of GDS for continuous improvement according to the established quality plan.
• Responsible for ensuring quality of all documentation, driving process improvements and tracking, trending and presenting trends of late submission root causes and other compliance related CAPAs as appropriate.
• Responsible for the investigation of late ICSRs, aggregate reports, including approval of single case deviations, development of corrective/preventative actions (CAPAs) and provide consultation as required
• Review deviations, identifies appropriate CAPAs
• Lead investigation of key compliance issues with the GDS
• Monitor timeliness of deviation and CAPA completions
• Manage, track and follow-up on corrective and preventative actions for GDS
• Assess effectiveness measures for CAPAs and corrective actions
• Perform data quality sampling and develop strategies for continuous quality improvement
• Work closely with the case management team to review and sample Individual Case Safety Reports (ICSRs) in (global safety database)
• Document data quality assessments
• Provide metrics on PV data quality assessments and assess effectiveness of resulting process improvements
• Responsible for collecting, coordinating, and analyzing all compliance and reconciliation metrics for ICSRs, aggregate reports and quality reviews
• Provide leadership for simplification and improvement in the PV process
• Interface with Global Drug Regulatory Affairs to: Coordinate , track and follow-up on Drug Safety regulatory document submissions (e.g., safety variations, periodic aggregate reports)
• In cooperation with the director of GSS & QPPV department, prepare job/role specific training curricula
• SOP maintenance, development, and implementation of Drug Safety SOPs across all drug safety activities, including responsibility for department training and training of Affiliates /vendors / business partners
• Track and follow-up on PV trainings on both local and global level
• Upon request, advises functional managers on the development of individual training plans
• Provide an input for the external training need of the Global Drug Safety team and communicate these needs to higher management staff
• Responsible for developing, reviewing and maintaining training materials related to Compliance and Key Performance Indicators.
• Contribute to Global PV training to ensure PV audit and inspections readiness, and understanding on preparation of high quality audit/inspection responses by all staff. Ensure collaboration and coordination with stakeholders in all GDS functions including affiliates.
• Develop, review, and maintain training materials related to audit and inspection readiness and audit/inspection response preparation across regions.
Audits & Inspection
• Manage internal, business partner and Health Authority audits/inspections
• Function as a subject matter expert for global PV regulatory requirements, inspections and audits
• Provide assertive leadership for a compliant environment
• Ensure coordination and support within GDS (before, during and after) for external audits & inspections; mentor and prepare GDS and affiliate staff for internal audits and external regulatory inspections.
• Perform trend analysis of aggregated inspection/audit findings to serve continuous improvements and to avoid repetitive findings.
• Manage the timely update and submission of the product information in line with the Art 57 requirements (xEVMPD)
• Identify and drive system or process changes to enhance data quality, user experience and compliance for the xEVMPD product information.
• Provide guidance and support for related initiatives, including system upgrades and enhancements in support of xEVMPD processes and obligations in collaboration with the IT organization.
• Monitor system performance and ensure that performance or capability issues are resolved effectively related to xEVMPD.
• Manage the design, validation and delivery of reports for compliance and dept KPIs for xEVMPD.
• Identify and communicate data errors and inconsistencies, and drive data remediation initiatives as required related to the xEVMPD product information.
• Delivery of effective system user training and system access promoting compliant use of MPD application, focused on the xEVMPD requirements.
• Ensure up to date process documentation, training materials and user guides for xEVMPD product information.
• Manage the IDMP implementation within the organization, ensure compliance to the EU requirements with regards to quality and timelines. This includes efforts such as data pilots, mapping of internal data/systems with IDMP, support migration from XEVMPD to IDMP…
• Monitor requirements change for IDMP, contribute and influence where possible to facilitate rapid implementation.
• Manage negociations with Vendor to maintain compliance and ensure implemented systems and processes are evolving with regulatory requirements.
• Life science degree (pharmacy, medicine, …) or equivalent through experience
• You have at least 5 years’ experience preferably in international Pharmacovigilance within a QPPV office supporting maintenance of the pharmacovigilance system
• Full awareness of EU GVP
• Highly analytical, process minded and detail oriented
• Be able to work in a matrix environment whilst remaining organized at all times
• You demonstrate initiative and capacity to work under pressure
• You have a hands on-mentality and a proactive attitude
• Your are fluent in English and have excellent communication skills. Knowledge of other European languages is an asset
015 21 11 04