Clinical Safety Manager (m / f / d)

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.

Responsibilities

We are seeking a Clinical Safety Manager responsible for overseeing safety management across Phase 1–4 clinical trials. This role ensures regulatory compliance (ICH, FDA / EMA), manages external safety service providers, and supports ongoing safety surveillance. Working closely with the Clinical Safety Physician and cross-functional teams, the manager plays a key role in maintaining safety standards across clinical development programs.

• Manage clinical safety activities across Phase 1–4 trials, ensuring compliance with global regulatory requirements and internal SOPs.
• Collaborate with cross-functional teams and external partners (, CROs, vendors) to ensure effective safety oversight and communication.
• Support the Clinical Safety Physician in the medical review of safety cases, including serious adverse events (SAEs), adverse events of special interest (AESIs), and pregnancy reports.
• Monitor and assess vendor performance in safety case processing, reporting, and compliance with contractual obligations.
• Prepare and distribute regular safety compliance and performance reports; coordinate issue resolution and necessary follow-up.
• Contribute to signal detection activities, periodic safety data reviews, and the development of aggregate safety reports.
• Review clinical trial and regulatory documents from a safety perspective, and support the development of key safety documents and plans (, Safety Management Plans, SDEAs).
• Organize and participate in safety-related meetings, including DSMB and SRC meetings, and support risk-benefit assessments.
• Participate in audits and inspections, contribute to SOP development, and deliver training on safety procedures.
• Maintain accurate documentation and filing of safety-related records in compliance with regulatory and company standards.

Requirements

Benefits

Working with Valneva means being part of a  global biotech company  with a clear vision to make a meaningful  impact in the world . At Valneva, you can expect a dynamic and  innovative  work environment characterized by an open, appreciative company culture and exciting,  impactful assignments . Enjoy the benefits of  flat hierarchies , an international atmosphere, and regular company events that foster  collaboration  and connection.

Additionally, we offer :

Join us and shape the future of biotechnology!

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.