Senior Manager for QPPV Operations
We are seeking a Senior Manager to support our Pharmacovigilance System Master File (PSMF) and related documents.
* Collaborate with the team on global and local literature screening processes to identify safety signals.
* Participate in process improvement initiatives, including SOPs and supporting documents.
* Schedule QPPV Oversight meetings and ensure subject matter experts attend.
* Schedule ad-hoc meetings with key partners and take meeting minutes.
* Foster cross-functional communication between the QPPV Office and global business.
Requirements
* Knowledge of European pharmacovigilance legislation and global pharmacovigilance requirements.
* Familiarity with the EMA GvP module.
* Ability to analyze complex issues, data, and PV processes.
* Demonstrated initiative, creativity, and innovation skills.
* Collaborative leadership and partnership-building abilities.
Experience
* Bachelor's degree or equivalent experience.
* 8 years of experience in the pharmaceutical industry or regulatory authority, with direct pharmacovigilance experience.
* Proficiency in using drug safety databases and strong expertise in Microsoft Office.
We offer a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off.
Regeneron is an equal opportunity employer and welcomes applications from diverse candidates.