Senior Safety Officer

Excelya; France; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading health company in France is seeking a Senior Safety Officer to oversee the compilation and review of safety reports within pharmacovigilance. Candidates should have at least 3 years of experience in the field, with a strong background in medical writing and aggregate safety reports. Passion for science and teamwork is essential, as well as fluency in English and preferably French. This role offers the opportunity to contribute to meaningful projects in a supportive environment.

Qualifications

• Minimum 3 years of experience in pharmacovigilance.
• At least 2 years of hands-on experience writing aggregate safety reports.
• Strong knowledge of ICH E2C(R2), E2F, and GVP guidelines.

Responsabilités

• Compile, author, and review aggregate periodic safety reports.
• Lead the development of high-quality safety reports.
• Support pharmacovigilance activities and regulatory submissions.

Connaissances

Medical writing expertise

Analytical skills

Attention to detail

Fluent in English

French proficiency

Formation

Degree in Life Sciences

Advanced degree (MSc, PhD)

Description du poste

Senior Safety Officer

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.
• 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.

Seniority Level

• Mid‑Senior level

Employment Type

• Full‑time

Job Function

• Management and Manufacturing

Industries

• Pharmaceutical Manufacturing