Manager Gps Pv Intelligence Temporary (Remote)

We are seeking a dedicated and experienced GPS PV Intelligence Manager to join our Global Patient Safety team. This role is pivotal in ensuring the identification, review, and dissemination of new and updated regulatory information specific to pharmacovigilance. If you are passionate about patient safety and regulatory compliance, this is an excellent opportunity to make a meaningful impact. This is a 14-month contractor role.

A Typical Day Might Include The Following

• Act as the GPS liaison to Regeneron Regulatory Intelligence Committees, focusing on pharmacovigilance-specific regulatory information.
• Coordinate with other GPS functions to review new/updated regulatory information and ensure compliance with global regulatory safety requirements.
• Liaise with GPS functions to implement changes to processes, procedures, and training to address new or updated PV regulatory requirements.
• Collaborate with Regulatory Affairs Regulatory Intelligence counterparts to ensure the availability and awareness of accurate and timely PV-specific regulatory requirements.
• Track regulatory intelligence information escalation within GPS and follow up on outstanding open items.
• Manage corrective and preventative actions as assigned.

This Role May Be For You

• You have a strong understanding of pharmacovigilance, regulatory compliance and legislation.
• You excel in coordinating and implementing changes to processes and procedures.
• You are adept at managing complex issues and providing clear direction.
• You possess excellent communication skills and can work well with people at all levels of the organization.
• You are self-motivated and can manage multiple priorities with a sense of urgency.

The ideal candidate will have a Bachelor’s degree (Master’s preferred) in life sciences and a minimum of 7+ years of relevant proven experience, including 5+ years in Pharmacovigilance/Drug Safety. Proficiency in Microsoft Office and a solid understanding of post-marketing pharmacovigilance and clinical trial safety regulations (EMA, MHRA, FDA, PMDA) are essential. Strong project management, organizational, and writing skills are also required.

Join us in our mission to ensure patient safety and regulatory compliance. Apply today to be part of a team that makes a difference.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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.