Safety Specialist, (Belgium, Home-based) - IQVIA MedTech

IQVIA MedTech Clinical Solutions, including genae which is a fully owned business unit of IQVIA, specializes in clinical research for Medical Devices and In-Vitro Diagnostic (IVD) products.

IQVIA MedTech’s focused expertise meets the growing needs of device Sponsors to justify product safety and effectiveness as well as reimbursement and adoption challenges due to increased scrutiny by regulators, end-users, and patients.

We have a vacancy within our Clinical Safety Team for an (experienced) permanent Safety Specialist to join our team throughout Germany or Belgium.

Basic Functions:

Prepares and performs safety reporting to Reviewing Committees and Regulatory Authorities according to the relevant legislation and guidelines for clinical trials with medical devices under supervision of the Safety Manager.  Assists the Safety Manager with the Clinical Event Committee (CEC) and Data Monitoring Committee (DMC) management.  

Responsibilities:

• Processes events from designated clinical trials, including receipt, review, case triage and regulatory reporting assessment.
• Completes safety reporting tables, national safety forms and periodic safety reports.
• Writes event narratives.
• Performs expedited and periodic safety reporting to the involved Reviewing Committees and Regulatory Authorities in compliance with the relevant reporting requirements and safety guidelines (Meddev 2.7/3).
• Tracks compliance reporting.
• Assists with preparation, conduction and follow up of Data Monitoring Committee Board and Clinical Event Committee meetings.
• Communicates with Clinical Research Associate, Reviewing Committees, Regulatory Authorities and CEC/DMC members.
• Reports on  activities in a timely fashion to the Safety Manager.
• Ensures safety reporting tracking systems remain up to date.
• Assures adherence to Good Clinical Practices and compliance with all IQVIA MedTech SOPs and study procedures and safety manuals.  
• May draft study safety manuals and other related documents, as requested by the Safety Manager.
• Attends study-related, company, departmental, and external meetings, as required.
• Ensures all study deliverables are completed per IQVIA MedTech and study timelines.

Knowledge, skills and abilities:

• You have a (para-) medical or scientific degree and by preference relevant experience in clinical research and processing of safety events.
• Fluent in English, by preference in more languages.
• Excellent written and verbal communication skills.
• Excellent planning and organizational skills with proven time-management capability.
• Detail-oriented and pro-active with a strong analytical mindset.
• Able to form productive professional relationships both internally within own function, cross-functionally and externally with health care professionals.
• Able to handle several priorities within multiple, complex trials.
• Able to reason independently and recommend specific solutions in clinical settings.
• Able to work independently, prioritize, and work within a matrix team environment.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.