We are seeking a dedicated and dynamic Senior Manager to join our Global Patient Safety team, specifically supporting the Qualified Person(s) for Pharmacovigilance (QPPV) and their deputy. As a vital member of the QPPV Office, you’ll play a key role in ensuring the efficient functioning of global pharmacovigilance systems. This position offers an exciting opportunity to contribute to patient safety worldwide while being part of a collaborative and innovative environment.
Monitor and maintain the QPPV Office mailbox, ensuring timely responses and updates.
Schedule QPPV Oversight meetings, coordinate attendance of subject matter experts, and prepare meeting minutes.
Manage the QPPV Office SharePoint site, ensuring content is organized and accessible.
Support the creation and maintenance of the Pharmacovigilance System Master File (PSMF) and its derivatives in compliance with EU and global legislation.
Facilitate cross-functional communication between the QPPV Office and global business units.
Participate in process improvement initiatives within the global safety department, enhancing operational efficiency.
Collaborate on the development and maintenance of Standard Operating Procedures (SOPs), Working Instructions (WIs), and Business Process Tools.
Assist with inspection readiness activities to ensure compliance with regulatory requirements.
You thrive in a collaborative, international matrix environment and excel at building partnerships internally and externally.
You have a strong understanding of European pharmacovigilance legislation and global regulatory requirements.
You possess exceptional organizational skills and can manage complex projects with precision.
You are proficient in Microsoft Office and drug safety databases, with technical writing expertise.
You bring direct pharmacovigilance experience in pharmaceuticals or biologics and have knowledge of EMA GvP modules.
You are innovative, detail-oriented, and passionate about contributing to patient safety.
You are skilled in problem-solving and can analyze diverse issues and data effectively.
Candidates must have direct pharmacovigilance experience within the pharmaceutical industry or regulatory authority, with a focus on pharmaceuticals and/or biologics. Knowledge of European pharmacovigilance legislation, global regulatory requirements, and PV quality systems is essential. Proficiency in drug safety databases, Microsoft Office, and technical writing is required. Preferred qualifications include experience with EMA GvP modules and a proven ability to manage collaborative partnerships in an international matrix environment.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.