Senior Manager EU/UK QPPV Operations Lead

3 weeks ago


United Kingdom Regeneron Ireland DAC Full time £12,000
Senior Manager EU/UK QPPV Operations Role

Regeneron Ireland DAC is seeking a highly skilled Senior Manager to join our QPPV operations department. As a key member of our team, you will play a crucial role in supporting the creation and maintenance of our Pharmacovigilance System Master File (PSMF) and all corresponding documents and annexes.

Key Responsibilities:
  • Collaborate with our team to support global and local literature screening processes to identify and assess safety signals.
  • Participate in process improvement initiatives, including the development and maintenance of relevant SOPs, WIs, and supporting documents.
  • Schedule QPPV Oversight meetings, ensuring subject matter experts are present, and collate metrics/data for presentation.
  • Facilitate and enhance cross-functional communication with the QPPV Office and the global business.
Requirements:
  • Knowledge of European pharmacovigilance legislation and global pharmacovigilance requirements.
  • Strong grasp of the EMA GvP module.
  • Ability to build and lead collaborative partnerships within the organization and externally.
  • Proven experience in the pharmaceutical industry or regulatory authority, with direct pharmacovigilance experience.
  • Proficiency in the use of drug safety databases or equivalent, with strong expertise in Microsoft Office.
What We Offer:

Regeneron Ireland DAC is an equal opportunity employer and offers a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees. We are committed to creating an inclusive and diverse culture that provides opportunities for growth and development.


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