Senior Safety Officer

il y a 5 jours

Paris, Île-de-France Excelya Temps plein

Join Excelya, where Audacity, Care, and Energy define who we are and how we work.

We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to join our dynamic and ambitious Pharmacovigilance and Safety team. Rooted in a long-standing tradition of excellence in pharmacovigilance, our department continues to evolve rapidly, offering a vivid, forward-thinking work environment that embraces innovation and growth 

We are seeking a Senior Safety Officer with a primary focus on the compilation, authoring, and review of aggregate periodic safety reports, including PSURs/PBRERs, DSURs, and ACOs. The role leads the coordination and development of high-quality safety reports including clinical safety evaluations, cumulative safety analyses, and benefit–risk assessments in line with global regulatory requirements. In addition to aggregate reporting and related medical writing activity, the position may support additional pharmacovigilance activities such as risk management, regulatory submissions, compliance oversight, SOPs, training, audits, and CAPA implementation.

Requirements

·       Education: Degree in Life Sciences (Pharmacy, Medicine, Biology, Chemistry); advanced degree (MSc, PhD) is a plus

·       Languages: Fluent in English; French proficiency preferred

·       Experience: Minimum 3 years in pharmacovigilance, including at least 2 years hands-on experience writing aggregate safety reports (DSURs, PSURs/PBRERs)

·       Skills: Strong medical writing expertise, including clinical safety evaluations, benefit–risk assessments, and cumulative safety analyses; ability to translate complex data into clear, regulatory-compliant narratives; solid knowledge of ICH E2C(R2), E2F, and GVP guidelines; strong analytical skills and attention to detail

Benefits

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here's what makes us unique—

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

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