EU QPPV – France

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

What we offer:

The QPPV will implement and maintain the PV System. Under the supervision of the CMO, the EU QPPV will: 

• Oversee Regulatory Compliance:
  Ensure adherence to European pharmacovigilance regulations by implementing and monitoring internal procedures.

• Coordinate Product Safety Activities:
  Organize and supervise all processes related to drug safety monitoring, including the collection, assessment, and reporting of adverse events.

• Manage Safety Reports:
  Prepare and validate periodic safety update reports (PSURs) and continuously assess the benefit-risk profile of products.

• Liaise with Health Authorities:
  Act as the primary contact for regulatory agencies, ensuring clear and effective communication.

• Develop Pharmacovigilance Procedures:
  Create and maintain up-to-date standard operating procedures (SOPs) to support effective drug safety management.

• Training and Awareness:
  Train internal teams on pharmacovigilance requirements and foster a culture of compliance and vigilance.

• Audits and Inspections:
  Prepare for and support regulatory audits and inspections, ensuring appropriate corrective and preventive actions are implemented.

• Ongoing Risk Monitoring:
  Implement and oversee risk management plans (RMPs) to identify and mitigate potential drug-related risks.

• Continuous Process Improvement:
  Propose and implement improvements to optimize pharmacovigilance practices and enhance overall operational efficiency.