Senior Pharmacovigilance Officer

Excelya; Paris; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A growing health company is seeking a professional in Pharmacovigilance to supervise case management and ensure compliance with regulations. The ideal candidate will have a Master's degree in Life Sciences, experience in fast-paced environments, and fluency in English and French. Join a dynamic team dedicated to making an impact in clinical research and enjoy a stimulating work environment that promotes growth and collaboration.

Qualifications

• Proven ability to thrive in collaborative, fast-moving environments.
• Fluent in written and spoken English and French.
• Strong communication skills with global teams.

Responsabilités

• Supervise pharmacovigilance case management.
• Monitor case processing timelines and investigate delays.
• Support review and validation of clinical study case narratives.

Connaissances

Collaboration

Knowledge of PV regulations

Data quality assurance

MedDRA coding

Narrative writing

Formation

Master's degree in Life Sciences

Outils

Argus Safety

Description du poste

Overview

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 contribute to a dynamic, ambitious team in Pharmacovigilance. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Responsibilities

• Supervise pharmacovigilance case management outsourced to assigned platform(s)
• Respond to case-related emails and inquiries from external service providers
• Monitor case processing timelines and investigate any delays in reporting or transmission
• Participate in weekly quality control of data entry, MedDRA coding, and narrative writing
• Support the review and validation of clinical study case narratives for inclusion in study reports
• Contribute to the reconciliation of PV cases with business partners per Safety Data Exchange Agreements (SDEAs)
• Oversee reconciliation of cases with clinical databases managed by outsourced providers
• Collaborate closely with cross-functional and global teams to ensure compliance and data integrity

Requirements

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: Proven ability to thrive in collaborative, fast-moving environments.
• Skills: Solid understanding of international PV regulations (EMA, FDA, MHRA, PMDA, Health Canada, etc.), proficient in using Argus Safety or similar safety database systems, excellent skills in MedDRA coding, narrative writing, and ensuring high data quality.
• Education: Master\'s degree or higher in Life Sciences (Pharmacy, Nursing, Medicine, or related field).
• Languages: Fluent in written and spoken English and French; strong communication skills with global teams.

Benefits

Why Join Us?

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

Company Highlights

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.