Senior Manager, QPPV Operations
Regeneron is seeking a Senior Manager to support our Pharmacovigilance System Master File (PSMF) creation and maintenance.
Key Responsibilities:
* Collaborate with our team on global and local literature screening processes.
* Participate in process improvement initiatives, including SOPs, WIs, and supporting documents.
* Schedule QPPV Oversight meetings and ensure subject matter experts are present.
* Facilitate cross-functional communication with the QPPV Office and global business.
Requirements:
* Knowledge of European pharmacovigilance legislation and global pharmacovigilance principles.
* Strong grasp of the EMA GvP module.
* Ability to analyze complex issues and data.
* Exceptional initiative, creativity, and innovation skills.
* Capacity to build and lead collaborative partnerships.
Qualifications:
* Bachelor's degree or equivalent experience.
* 8+ years of experience in pharmaceutical industry or regulatory authority.
* Direct pharmacovigilance experience with proficiency in drug safety databases.
* Strong expertise in Microsoft Office.