DBV Technologies

Translator

• Translate documents and content from French to English and English to French with accuracy and clarity
• Review and revise translations to ensure consistency, grammar, tone, and style alignment
• Collaborate with the Quality, Regulatory, and Manufacturing/MSAT team to maintain and improve translation standards and guidelines
• Perform proofreading and quality checks on translated materials
• Assist in maintaining glossaries, style guides, and translation memories
• Flag linguistic or content issues and suggest improvements
• Meet deadlines while managing multiple translation tasks
• Conduct quality checks, proofreading, and editing of translated materials
• Manage multiple translation projects simultaneously while meeting tight deadlines

Director

• Provide biostatistical leadership to support clinical development strategy, protocol design, and endpoint selection.
• Lead analysis planning and execution, including SAP development, interim/ad hoc analyses, and interpretation of study results.
• Oversee statistical programming deliverables and ensure fit-for-purpose QC and traceability.
• Partner cross-functionally to deliver high-quality clinical study reports and support regulatory submissions.

Associate Director, Biostatistics

• Represent the PV function in cross-functional projects and teams, partnering with Drug Safety Physicians to develop safety surveillance strategies and contribute to benefit-risk assessments for assigned products.
• Support the evaluation and management of safety signals from all data sources, including signal detection, benefit-risk profile assessment, and aggregate reporting activities.
• Oversee, prepare, and/or review safety documents including periodic safety reports (PSURs/PBRERs), DSURs, signal evaluation reports, risk management plans, and other safety-related documents.
• Formulate and contribute to responses to health authority inquiries related to product safety.
• Partner with the Clinical team to support safety management plans and medical monitoring strategies for clinical programs.

Senior Director, Pharmacovigilance Scientist

Operations

• Lead and oversee all PV operational activities, including adverse event intake, case processing, quality review, and regulatory reporting.
• Ensure timely and compliant submission of expedited safety reports (e.g., SAEs, SUSARs, MDRs) and lead aggregate safety reporting activities (e.g., DSURs, PSURs/PBRERs).
• Manage PV vendor relationships, including case processing and safety database vendors; establish and monitor KPIs, quality metrics, and service performance.
• Oversee the safety database and associated workflows to ensure data integrity, inspection readiness, and regulatory compliance.
• Develop, implement, and maintain PV SOPs, work instructions, and operational processes aligned with FDA, Health Canada, EMA, ICH, and global PV regulations.
• Serve as the primary PV Operations interface with Medical Affairs, Clinical Development, Regulatory Affairs, Quality, and external partners.
• Lead and/or contribute to safety governance activities and committees.
• Drive inspection and audit readiness, including supporting the hosting of health authority inspections.
• Serve as a key contributor to health authority inquiry responses and interactions.
• Mentor and develop PV Operations staff and contribute to the growth and scaling of the pharmacovigilance function.

Translator

Associate Director, Biostatistics

Senior Director, Pharmacovigilance Scientist

Senior Director, Pharmacovigilance Operations