Global Case Processing Specialist

About Excelya

At Excelya, we combine passion, scientific excellence, and collaboration to support our clients across the entire drug development lifecycle. As a trusted partner of leading pharmaceutical and biotechnology companies, we are looking for a Pharmacovigilance Case Processing Officer to join a global safety team and contribute to the delivery of high-quality pharmacovigilance activities in an international environment.

Missions

As a Pharmacovigilance Case Processing Officer, you will support the Global Safety team and ensure the timely and compliant management of case processing activities.

Your main responsibilities will include:

• Acting as a point of contact for case processing vendors and responding to operational queries related to case management activities.
• Monitoring case processing timelines and identifying root causes of delays in case reporting and submissions.
• Performing regular quality reviews of pharmacovigilance cases, including:
• Data entry verification
• MedDRA coding review
• Narrative review and quality assessment
• Consistency checks against source documentation
• Managing and tracking corrections, clarifications, and follow-up requests with external partners and vendors.
• Reviewing and approving quality control activities for assigned products and studies.
• Supporting pharmacovigilance case reconciliation activities with business partners and external service providers in accordance with Safety Data Exchange Agreements (SDEA) and Pharmacovigilance Agreements (PVA).
• Contributing to deviation management activities, including Root Cause Analysis (RCA), CAPA development, and continuous quality improvement initiatives.
• Collaborating closely with Pharmacovigilance Quality, Global Safety Operations, and cross-functional stakeholders.

Requirements

At Excelya, we encourage everyone to be bold, take initiative, and unlock their full potential. We are looking for professionals who share our values and are eager to grow in a dynamic and stimulating environment.

Education: Bachelor's degree or higher in Pharmacy, Life Sciences, Nursing, Medicine, or a related scientific discipline.

Experience : Solid experience in Pharmacovigilance with strong expertise in Case Processing and Case Management.

Technical Skills: Hands-on experience with Argus Safety or equivalent safety databases.

• Strong knowledge of global pharmacovigilance regulations and guidelines, including: EMA, FDA, MHRA, PMDA, Health Canada, ICH E2B, MedDRA, GVP, CIOMS
• Excellent MedDRA coding and narrative writing skills. Experience performing quality control and quality review of safety cases. Familiarity with vendor management and outsourced pharmacovigilance activities.
• Strong analytical, organizational, and problem-solving skills, Ability to manage multiple priorities in a fast-paced international environment. Excellent communication skills and ability to collaborate with global teams.
• Proficiency in Microsoft Office tools.

Languages :

• Fluent English (written and spoken).

Benefits

Why join us?

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

Here's what makes us unique:

We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience.

Our "one-stop provider" service model-combining full-service, functional service provider, and consulting-allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey.

Excelling with kindness means evolving in an environment that values your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.