Pharmacovigilance Officer

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

Résumé du poste

A dynamic clinical research firm in Paris is seeking a Pharmacovigilance Specialist to supervise case management and ensure regulatory compliance. Suitable candidates will have a Doctor of Pharmacy (PharmD) and solid experience in PV regulations. Responsibilities include supervising pharmacovigilance cases, responding to inquiries, and monitoring timelines. Join a workplace that fosters growth, collaboration, and a commitment to excellence in healthcare.

Qualifications

• Proven ability to thrive in collaborative, fast-moving environments.
• Strong communication skills with global teams.
• Experience in regulatory compliance indicators.

Responsabilités

• Supervise pharmacovigilance case management.
• Respond to case-related inquiries from providers.
• Monitor case processing timelines.

Connaissances

Solid understanding of global PV regulations

Experience in managing CAPAs

Familiar with audits and inspections

Formation

Doctor of Pharmacy (PharmD) degree

Description du poste

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.

Main 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

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 (talent matters most to us!)
• Skills: Solid understanding of global PV regulations and quality systems, experience in managing CAPAs, deviations, and regulatory compliance indicators, familiar with the preparation and conduct of audits and inspections (internal and external).
• Education: Doctor of Pharmacy (PharmD) degree required.
• Languages: Fluent in written and spoken English and French; strong communication skills with global teams.

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’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.