OVERVIEW
FOCUS AREAS
Over 7 years of global experience in pharmacovigilance operations, signal detection, and compliance monitoring.
Late case monitoring and CAPA management
Quality improvement and KPI analysis
Cross-functional project leadership
Process design and SOP development
Arnaud Bertrand is a Pharmacovigilance consultant with over seven years of international experience in drug safety and medical information operations. Specializing in PV workflow optimization, global project execution across 15+ countries, and signal detection, Arnaud has led quality improvement initiatives and managed complex safety data portfolios for top-tier pharmaceutical companies. His expertise spans case processing, compliance monitoring, and process design.
Arnaud has held diverse roles including project manager support, business analyst, and workstream lead, contributing to complex PV projects for leading pharmaceutical clients. Arnaud has worked extensively with safety databases such as Argus and Veeva Safety, and has been actively involved in signal detection and management initiatives. Dedicated to streamlining workflows, enhancing compliance, and transforming data into strategic actions, he approaches each engagement with a collaborative mindset and a focus on practical, results-driven solutions.
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EDUCATION:
- Bachelor’s degree European Public Health at Maastricht University, NL
- Specialization Social and Environnement Entrepreneurship
- Cambridge C1 proficiency diploma
CERTIFICATIONS:
- Signal Detection and Management in Pharmacovigilance Certificate at Udemy PV Drug Safety Academy
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Professional Experience
- Truliant Consulting (Sep 2022 – Present)
Roles: Project Manager Support, Business Analyst, Workstream Lead
Responsibilities: Project coordination, stakeholder engagement, data analysis, process improvement - IQVIA (Jun 2019 – Aug 2022)
Roles: Workflow Lead, Pharmacovigilance Specialist on Argus Safety
Responsibilities: ICSR process oversight, workflow optimization, compliance monitoring - Abbott Diabetes Care – Sitel (Feb 2018 – Jun 2019)
Roles: Healthcare Consumer Advisor, Product and Quality Specialist
Responsibilities: Medical information handling, quality support, consumer engagement
Leadership Positions
- Workstream Lead on global PV compliance and process improvement projects
- Lead for Argus workflow coordination and quality monitoring initiatives
- Workshop coordinator with trainers and quality leads to implement improvement plans
Detailed Areas of Expertise
- Pharmacovigilance Operations and Workflow Optimization
- Case Processing and Compliance Monitoring (Late Case, PM Safety Data)
- Signal Detection and Management
- Safety Database Experience: Argus, Veeva Safety
- KPI Calculation and Data Analysis for Quality Improvement
- CAPA (Corrective and Preventive Actions) Analysis and Documentation
- Process Design, SOP Authoring, and Quality Monitoring Plans
- Global Project Execution (Experience in 15+ countries)
- Audit Support and Deliverables Preparation
- Stakeholder Engagement and Cross-functional Collaboration
- Root Cause Analysis and Trend Identification
- Truliant Consulting (Sep 2022 – Present)