Safety Periodic Reports Lead

Excelya Group; Saclay; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A leading health company in Saclay is seeking a Pharmacovigilance Specialist to lead the development of safety periodic reports. The ideal candidate has a strong background in pharmacovigilance and a Master's degree in Life Sciences or Pharmacy. You will contribute to high-quality pharmacovigilance services, ensuring compliance with industry regulations while working in a dynamic team environment. Fluency in both French and English is required, along with excellent analytical and communication skills.

Prestations

Inclusive work environment

Passion for science

Opportunities for growth through diverse projects

Qualifications

• Strong background in pharmacovigilance and experience in writing safety periodic reports.
• Proficient knowledge of regulatory guidelines (e.g., GVP, ICH) and best practices.
• Fluency in French and English (both written and spoken).

Responsabilités

• Prepare, coordinate, and maintain product safety profiles.
• Support the planning and delivery of periodic safety reports.
• Draft expert safety reports and responses to Health Authority questions.
• Lead and update Risk Management Plans for assigned products.
• Ensure proper tracking and submission of safety reports.

Connaissances

Analytical skills

Communication

Interpersonal skills

Teamwork

Attention to detail

Formation

Master’s degree in Life Sciences or Pharmacy

Description du poste

About the Job

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 lead the development of safety periodic reports within our dynamic and ambitious Safety team. You will contribute to high-quality pharmacovigilance services while ensuring compliance with industry regulations and standards in a stimulating professional environment.

Main Responsibilities

• Contribute to the preparation, coordination, and maintenance of product safety profiles within the Global Safety department, in compliance with internal procedures
• Support the planning and delivery of periodic safety reports (DSURs, PSURs, Clinical Overviews) in collaboration with Safety Periodic Reports Leads and PV Project Leads
• Draft and coordinate ad hoc expert safety reports, responses to Health Authority questions, and other safety data analyses
• Lead and update Risk Management Plans (RMPs) for assigned products
• Monitor and oversee the external service provider responsible for the coordination and drafting of periodic reports
• Ensure proper tracking and submission of safety reports to Health Authorities
• Participate in regulatory impact assessments related to periodic reporting and safety requirements
• Contribute to project teams and Medical Safety Teams as a pharmacovigilance representative when required

About You

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

• Experience: Strong background in pharmacovigilance and experience in writing safety periodic reports.
• Education: Minimum Master’s degree (Bac +5) in Life Sciences, Pharmacy, or a related field.
• Skills: Excellent analytical skills with a keen attention to detail; proficient knowledge of regulatory guidelines (e.g., GVP, ICH) and best practices in pharmacovigilance.
• Languages: Fluency in French and in English (both written and spoken).
• Soft Skills: Exceptional communication and interpersonal skills; able to work effectively in a team and manage relationships across departments.

Why Join Us?

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’sleading mid-size CROwith thebest employee experience. Ourone-stop provider service model, offering full-service, functional service provider, and consulting, enables you to evolve through diverse projects.

Excelling with caremeans 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.