Global Case Processing Specialist

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.

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.

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.

• Fluent English (written and spoken).