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

Mains Responsibilities :

The position involves performing as Local Contact Person responsible for Pharmacovigilance for Paris and participating in local/global projects within the Pharmacovigilance (PV) and Safety department.

Work in several aspects of pharmacovigilance shall be expected, such as

Manage pharmacovigilance (PV) case processing, including receipt, acknowledgement, coding (MedDRA), seriousness assessment, and timely forwarding to the external PV provider.

Conduct follow‑up activities with reporters to obtain additional case information.

Handle increased PV case volumes during Early Access Programs (ATU/AAP).

Perform regular reconciliations with multiple stakeholders (PV vendor, MedInfo, QA, DSE, Business Partners, CRM, Market Research agencies, ATU/AAP provider, Global MedInfo).

Review Market Research questionnaires in Veeva PromoMats and evaluate local partner questionnaires for compliance.

Draft file notes for late case reporting and support CAPA processes.

Update monthly and quarterly Affiliate PV reports.

Contribute to regulatory and scientific activities, including PSUR/PBRER and RMP summaries, weekly literature screening, and reimbursement dossiers.

Support updates of local SOPs and deliver PV training to internal and external stakeholders.

Provide transversal support, including LSO backup, participation in Affiliate and DSE meetings, and maintenance of PV archives in SharePoint.

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.

Education: Pharmacist or Pharmaceutical Degree

Experience: Minimum 2 years of relevant experience in pharmacovigilance, preferably within a global working environment.

Skills: Strong organizational skills with high attention to detail; proven ability to work both independently and collaboratively in a demanding multinational context; goal- and client-oriented mindset; demonstrated success in handling diverse tasks efficiently

Technical: Proficient in MS Windows and MS Office; experience with safety databases and/or possession of an Eudravigilance certificate considered an asset. Codage MedDRA is Mandatory and GVP Modules

Languages: Excellent command of English (written and spoken)

Soft-Skills: Self-motivated, strong communication skills, and a true team player.

Benefits:
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.