Ividata Life Sciences

Compliance

• Draft and review regulatory documents for clinical investigations involving medical devices, including protocols, Investigator’s Brochures (IBs), and regulatory dossiers
• Contribute to the preparation of submissions to competent authorities and ethics committees in a European and/or international context
• Ensure documents comply with the Medical Device Regulation (MDR) 2017/745 and applicable guidelines
• Collaborate with clinical, quality, biometrics, and regulatory affairs teams
• Contribute to regulatory strategy for medical device clinical investigations
• Ensure the quality, consistency, and traceability of data in produced documents
• Contribute to document management and the updating of regulatory templates
• Provide consulting services to pharmaceutical and biotechnology clients on high-value projects

Regulatory Affairs Consultant – Medical Devices

Database Administrator

• Enter, enrich, and update product regulatory data in RIM and PMS databases
• Analyze and leverage source dossiers, particularly eCTD dossiers, to identify manufacturer, site, and activity data
• Verify the compliance and accuracy of data integrated into the EMA PMS database as part of the eDMP project
• Identify inconsistencies or errors between different systems and perform data-cleansing activities
• Ensure the ongoing reliability of packaging information and packaging items
• Contribute to drafting and updating standard operating procedures related to regulatory data management
• Collaborate with Regulatory Affairs and IT teams to optimize data flows and eliminate duplicate data entry
• Work on high-value projects for clients in the pharmaceutical and biotechnology sectors

Consultant – Regulatory Database Administrator

Consultant

• Lead, train, and provide day-to-day support to a team of in-house and outsourced Clinical Research Associates (CRAs)
• Conduct performance reviews and monitor team members’ professional development
• Oversee the management and follow-up of investigator sites
• Review and approve site selection, initiation, monitoring, and close-out visit reports
• Ensure recruitment targets are met
• Ensure compliance with study protocols, ICH Good Clinical Practice (ICH-GCP), and applicable regulations
• Participate in study budget monitoring
• Manage key performance indicators (KPIs)
• Manage relationships with service providers, including CROs and laboratories
• Anticipate risks and manage major protocol deviations
• Implement corrective and preventive action (CAPA) plans
• Collaborate with pharmaceutical and biotechnology clients on high-value projects

Consultant – CRA Manager

Pharmacist

• Oversee the regulatory compliance of ICSR (Individual Case Safety Reports)
• Monitor the timeliness of submissions to health authorities and partners
• Conduct root cause analyses in the event of delays
• Analyze compliance trends
• Implement corrective action plans
• Escalate identified issues
• Propose appropriate solutions
• Contribute to the continuous improvement of pharmacovigilance processes
• Meet the client’s critical submission timeline objectives
• Work across the pharmaceutical, biotechnology, medical device, animal health, cosmetics, and nutrition sectors

Consulting Pharmacist – Quality and Pharmacovigilance

• Supervise global case management activities across one or more pharmacovigilance platforms
• Monitor key performance indicators (KPIs) and report on them to Safety leads and Quality teams
• Provide hands-on operational support, including case quality review, issue resolution, and day-to-day team guidance
• Manage case processing and transmission timelines in accordance with regulatory and contractual requirements
• Coordinate and oversee external case processing and literature screening providers
• Organize and participate in regular operational meetings with service providers
• Reconcile cases with partners and clinical databases (SDEA/PVA)
• Contribute to the management of CAPAs, audits, inspections, and quality documents related to case processing
• Collaborate with PV systems teams to integrate regulatory intelligence updates into safety databases
• Support pharmaceutical and biotechnology clients on high-value projects

Consultant – Pharmacovigilance Case Processing Lead

QA Engineer

• Deploy and lead the Quality policy across the French subsidiary, in compliance with regulatory requirements and Group procedures
• Lead the quality management system and contribute to the continuous improvement of internal processes and practices
• Oversee the pharmacovigilance and safety surveillance system in accordance with regulatory requirements and local and international procedures
• Serve as the Local Safety Officer (LSO) and the person responsible for pharmacovigilance for the subsidiary
• Oversee the maintenance and updating of pharmacovigilance reference documentation
• Contribute to safety signal detection and assessment activities
• Monitor regulatory developments and assess their impact on the subsidiary’s activities
• Coordinate interactions with health authorities and healthcare professionals on product safety matters
• Oversee the management of quality incidents, complaints, audits, and inspections, as well as the follow-up of corrective and preventive actions
• Provide pharmacovigilance, quality, and risk management expertise to the company’s various functions
• Contribute to the collection, assessment, and follow-up of safety data generated through the company’s various programs and activities
• Escalate safety signals to the relevant stakeholders and contribute to defining action plans
• Manage and develop a Quality and Safety Surveillance team
• Support change, set priorities, and contribute to the evolution of methods and processes within the assigned scope
• Collaborate with pharmaceutical and biotechnology clients on high-value-added projects

Consultant – Pharmacovigilance and Quality Assurance Lead

Risk

• Lead the strategy and execution roadmap for the Advanced eDMS program’s document migration
• Design and refine the project’s associated budget model
• Convert existing data and processes into a structured, wave-based operational plan
• Prepare for and coordinate the arrival of the system integrator
• Facilitate workshops and present progress to governance committees
• Ensure regulatory compliance, including GxP, data integrity, and traceability
• Collaborate with IVIDATA Life Sciences teams and clients in the pharmaceutical and biotechnology sectors