Freelance Qualified Person for Pharmacovigilance (QPPV) - Remote

Overview

At Clinigen, we're shaping the future of healthcare by delivering specialised pharmaceuticals and services that are essential for patients globally. Our dedicated team is comprised of ambitious and innovative professionals whose mission aligns with the larger goal of ensuring that the right medicine reaches the right patient at the right time.

In Short

• Act as the Qualified Person for Pharmacovigilance and/or Local Contact Person for PV for the EU and UK.
• Oversee pharmacovigilance activities, ensuring safety issues are managed appropriately.
• Ensure timely submission of safety reports to regulatory authorities.
• Establish and maintain the pharmacovigilance system and safety databases.
• Work with cross-functional teams to ensure compliance and implement risk management plans.
• Provide guidance for safety-related matters in clinical trials and post-marketing settings.
• Support with audits and inspections for compliance.
• Stay updated with changes to pharmacovigilance legislation.

Requirements

• Experience in pharmacovigilance and compliance with EU and UK regulations.
• Strong understanding of safety reporting and risk management.
• Excellent communication skills.
• Ability to work independently and collaboratively.
• Knowledge of clinical trial processes.

Benefits

• Flexible working arrangements.
• Opportunity to work on diverse projects.
• Collaborate with a dedicated team of professionals.
• Impact healthcare positively for patients.